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The Effect Of NS-0200 and NS-0300 Versus Placebo on Weight In Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03364335
Recruitment Status : Completed
First Posted : December 6, 2017
Results First Posted : November 27, 2018
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
NuSirt Biopharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Obesity
Interventions Drug: Leu Sil 1.0mg
Drug: Leu Sil 4.0mg
Drug: Leu Met Sil 1.0mg
Drug: Leu Met Sil 4.0mg
Drug: Placebo
Enrollment 267
Recruitment Details Subjects meeting all inclusion criteria and no exclusion criteria were randomized to one of five treatment arms in the ratio of 1:1:1:1:1(A:B:C:D:E). The randomization was stratified by a maximum of 70% female with a BMI range between 30 kg/m2 and 45 kg/m2
Pre-assignment Details The discrepancy in the number of enrolled subjects and the actual number that started the study is because some of the enrolled subjects did not start the study for the following reasons: they moved, were not compliant with investigator request or were sent on active military duty.
Arm/Group Title Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
Hide Arm/Group Description Placebo: Placebo

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID

Metformin: Metformin 500 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID

Metformin: Metformin 500 mg BID

Period Title: Overall Study
Started 52 51 53 50 52
Completed 42 40 42 37 41
Not Completed 10 11 11 13 11
Reason Not Completed
Adverse Event             3             4             1             2             0
Lost to Follow-up             7             7             10             11             11
Arm/Group Title Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg Total
Hide Arm/Group Description Placebo: Placebo

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID

Metformin: Metformin 500 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID

Metformin: Metformin 500 mg BID

Total of all reporting groups
Overall Number of Baseline Participants 52 51 53 50 52 258
Hide Baseline Analysis Population Description
Subjects who met the inclusion criteria, with BMI between 30kg/m2 and 45kg/m2.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 51 participants 53 participants 50 participants 52 participants 258 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
52
 100.0%
51
 100.0%
53
 100.0%
50
 100.0%
52
 100.0%
258
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 52 participants 51 participants 53 participants 50 participants 52 participants 258 participants
41.29  (11.30) 40.94  (11.14) 39.55  (11.14) 41.36  (12.66) 42.89  (10.70) 41.20  (11.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 51 participants 53 participants 50 participants 52 participants 258 participants
Female
38
  73.1%
29
  56.9%
32
  60.4%
39
  78.0%
35
  67.3%
173
  67.1%
Male
14
  26.9%
22
  43.1%
21
  39.6%
11
  22.0%
17
  32.7%
85
  32.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 51 participants 53 participants 50 participants 52 participants 258 participants
Hispanic or Latino
8
  15.4%
12
  23.5%
13
  24.5%
12
  24.0%
15
  28.8%
60
  23.3%
Not Hispanic or Latino
44
  84.6%
39
  76.5%
40
  75.5%
38
  76.0%
37
  71.2%
198
  76.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 51 participants 53 participants 50 participants 52 participants 258 participants
American Indian or Alaska Native
1
   1.9%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.4%
Asian
0
   0.0%
0
   0.0%
1
   1.9%
2
   4.0%
1
   1.9%
4
   1.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
9
  17.3%
9
  17.6%
13
  24.5%
11
  22.0%
11
  21.2%
53
  20.5%
White
40
  76.9%
42
  82.4%
39
  73.6%
37
  74.0%
40
  76.9%
198
  76.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   3.8%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.8%
Weight (kg)  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 52 participants 51 participants 53 participants 50 participants 52 participants 258 participants
101.67  (13.856) 105.05  (15.568) 107.16  (17.962) 100.18  (16.991) 104.50  (17.405) 103.74  (16.49)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 52 participants 51 participants 53 participants 50 participants 52 participants 258 participants
35.773  (3.31) 37.179  (4.28) 37.9  (4.20) 36.425  (4.13) 37.152  (4.23) 36.89  (4.08)
Waist Circumference  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 52 participants 51 participants 53 participants 50 participants 52 participants 258 participants
110.40  (10.998) 112.91  (11.466) 116.02  (12.411) 111.17  (13.291) 112.93  (13.311) 112.71  (12.39)
1.Primary Outcome
Title Percentage Body Weight Change
Hide Description The percentage body weight change from baseline to Day 168 was evaluated.
Time Frame Baseline to Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
ANCOVA Analysis for Primary Endpoint – Percent Change in Body Weight from Baseline to Day 168 in per protocol population.
Arm/Group Title Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
Hide Arm/Group Description:
Placebo: Placebo

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID

Metformin: Metformin 500 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID

Metformin: Metformin 500 mg BID

Overall Number of Participants Analyzed 42 40 42 37 41
Mean (Standard Deviation)
Unit of Measure: percentage
1.121  (3.6241) 0.674  (3.2286) -0.489  (3.9041) -0.929  (4.5533) -0.552  (2.5924)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 1.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.5461
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 4.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.0364
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 1.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.0156
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 4.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.0349
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Change in Absolute Body Weight
Hide Description The change in absolute body weight from baseline to day 168 was evaluated.
Time Frame Baseline to Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
ANCOVA Analysis for Secondary Endpoint – Change in Absolute Body Weight from Baseline to day 168 (Per-Protocol Population).
Arm/Group Title Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
Hide Arm/Group Description:
Placebo: Placebo

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID

Metformin: Metformin 500 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID

Metformin: Metformin 500 mg BID

Overall Number of Participants Analyzed 42 40 42 37 41
Mean (Standard Deviation)
Unit of Measure: kg
1.126  (3.5903) 0.678  (3.2502) -0.460  (4.0352) -0.870  (4.5445) -0.461  (2.7583)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 1.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.5348
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 4.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.0379
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 1.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.0215
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 4.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.0464
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Change in Percentage of Patients With ≥5% Body Weight Loss
Hide Description The number of patients with ≥5% body weight loss in each group was assessed from baseline to day 168.
Time Frame Baseline to Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis for Secondary Endpoint - Percentage of Subjects with ≥5% Relative Percentage Reduction from Baseline to day 168 in Body Weight by Treatment (Per-Protocol Population).
Arm/Group Title Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
Hide Arm/Group Description:
Placebo: Placebo

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID

Metformin: Metformin 500 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID

Metformin: Metformin 500 mg BID

Overall Number of Participants Analyzed 42 40 42 37 41
Measure Type: Count of Participants
Unit of Measure: Participants
2
   4.8%
1
   2.5%
6
  14.3%
7
  18.9%
3
   7.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 1.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Pearson’s Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 4.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Pearson’s Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.2646
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 1.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Pearson’s Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.0749
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 4.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Pearson’s Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.6758
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Change in Waist Circumference
Hide Description The change in waist circumference by using a tape measure across the mid-section was evaluated in subjects from baseline to day 168.
Time Frame Baseline to Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
ANCOVA Analysis for Secondary Endpoint – Change in Waist Circumference from Baseline (Per-Protocol Population).
Arm/Group Title Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
Hide Arm/Group Description:
Placebo: Placebo

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID

Metformin: Metformin 500 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID

Metformin: Metformin 500 mg BID

Overall Number of Participants Analyzed 42 40 42 37 41
Mean (Standard Deviation)
Unit of Measure: cm
0.043  (5.5591) 0.028  (5.5152) -1.060  (5.5564) -1.841  (4.7654) 0.637  (5.7908)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 1.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.9656
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 4.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.4254
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 1.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.1276
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 4.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.5937
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Change in Total Cholesterol
Hide Description Changes in total cholesterol was examined by standard blood chemistry.
Time Frame Baseline to Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
ANCOVA Analysis for Secondary Endpoint – Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population).
Arm/Group Title Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
Hide Arm/Group Description:
Placebo: Placebo

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID

Metformin: Metformin 500 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID

Metformin: Metformin 500 mg BID

Overall Number of Participants Analyzed 42 40 42 37 41
Mean (Standard Deviation)
Unit of Measure: mg/dL
1.0  (20.33) 0.2  (20.96) 1.9  (20.01) -0.7  (16.74) -6.6  (23.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 1.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.6010
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 4.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.6513
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 1.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.4354
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 4.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.0310
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
6.Secondary Outcome
Title Change in HDL Cholesterol
Hide Description Changes were measured in HDL cholesterol from Baseline to day 168 by standard blood chemistry.
Time Frame Baseline, Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
ANCOVA Analysis for Secondary Endpoint – Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population).
Arm/Group Title Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
Hide Arm/Group Description:
Placebo: Placebo

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID

Metformin: Metformin 500 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID

Metformin: Metformin 500 mg BID

Overall Number of Participants Analyzed 42 40 42 37 41
Mean (Standard Deviation)
Unit of Measure: mg/dL
1.1  (7.43) 0.6  (7.59) 2.4  (6.40) 1.8  (8.21) 1.6  (7.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 1.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.4644
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 4.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.8573
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 1.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.8167
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 4.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.9223
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
7.Secondary Outcome
Title Change in LDL Cholesterol
Hide Description Changes in LDL Cholesterol was measured by standard blood chemistry from baseline to day 168.
Time Frame Baseline, 168 days
Hide Outcome Measure Data
Hide Analysis Population Description
ANCOVA Analysis for Secondary Endpoint – Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population).
Arm/Group Title Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
Hide Arm/Group Description:
Placebo: Placebo

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID

Metformin: Metformin 500 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID

Metformin: Metformin 500 mg BID

Overall Number of Participants Analyzed 42 40 42 37 41
Mean (Standard Deviation)
Unit of Measure: mg/dL
-5.5  (15.40) -6.6  (16.86) -4.2  (15.81) -5.5  (11.77) -11.6  (19.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 1.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.6574
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 4.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.8971
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 1.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.6317
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 4.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.0341
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
8.Secondary Outcome
Title Change in Triglycerides
Hide Description The change in triglycerides was evaluated by standard blood chemistry in subjects from Baseline to Day 168.
Time Frame Baseline, Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
ANCOVA Analysis for Secondary Endpoint – Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population).
Arm/Group Title Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
Hide Arm/Group Description:
Placebo: Placebo

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID

Metformin: Metformin 500 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID

Metformin: Metformin 500 mg BID

Overall Number of Participants Analyzed 42 40 42 37 41
Mean (Standard Deviation)
Unit of Measure: mg/dL
13.4  (45.43) 9.7  (56.42) 1.9  (51.93) -4.4  (47.02) 3.5  (52.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 1.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.3720
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 4.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.2302
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 1.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.1377
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 4.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.4295
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
9.Secondary Outcome
Title Change in Plasma Glucose
Hide Description Change in plasma glucose was examined through standard fasting blood chemistry.
Time Frame Baseline to Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
ANCOVA Analysis for Secondary Endpoint – Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population).
Arm/Group Title Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
Hide Arm/Group Description:
Placebo: Placebo

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID

Metformin: Metformin 500 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID

Metformin: Metformin 500 mg BID

Overall Number of Participants Analyzed 42 40 42 37 41
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.4  (7.98) -1.6  (9.35) 0.3  (9.59) 1.1  (12.43) -1.7  (10.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 1.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.6726
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 4.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.7934
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 1.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.5485
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 4.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.3676
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
10.Secondary Outcome
Title Change in Hemoglobin A1c (HbA1c)
Hide Description Change in Hemoglobin A1c was assessed in the subjects from baseline to day 168.
Time Frame Baseline, Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
ANCOVA Analysis for Secondary Endpoint – Change in HbA1c from Baseline to day 168 (Per-Protocol Population).
Arm/Group Title Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
Hide Arm/Group Description:
Placebo: Placebo

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID

Metformin: Metformin 500 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID

Metformin: Metformin 500 mg BID

Overall Number of Participants Analyzed 42 40 42 37 41
Mean (Standard Deviation)
Unit of Measure: percentage of glycosylated hemoglobin
0.16  (0.164) 0.09  (0.167) 0.11  (0.165) 0.07  (0.198) 0.09  (0.177)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 1.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.1653
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 4.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.1970
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 1.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.0608
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 4.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.1583
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
11.Secondary Outcome
Title Change in Diastolic Blood Pressure
Hide Description Diastolic blood pressure was measured by standard blood pressure monitor.
Time Frame Baseline to Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
ANCOVA Analysis for Secondary Endpoint – Change in Blood Pressure from Baseline to day 168 (Per-Protocol Population)
Arm/Group Title Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
Hide Arm/Group Description:
Placebo: Placebo

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID

Metformin: Metformin 500 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID

Metformin: Metformin 500 mg BID

Overall Number of Participants Analyzed 42 40 42 37 41
Mean (Standard Deviation)
Unit of Measure: mmHg
-1.7  (7.13) 1.8  (9.57) -2.6  (8.10) 1.1  (9.16) -3.3  (7.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 1.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.0524
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 4.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.5221
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 1.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.3702
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 4.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.5426
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
12.Secondary Outcome
Title Change in Systolic Blood Pressure
Hide Description Change in Systolic blood pressure was assessed in patients from baseline to Day 168
Time Frame Baseline, Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
ANCOVA Analysis for Secondary Endpoint – Change in Blood Pressure from Baseline to day 168 (Per-Protocol Population).
Arm/Group Title Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
Hide Arm/Group Description:
Placebo: Placebo

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID

Metformin: Metformin 500 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID

Metformin: Metformin 500 mg BID

Overall Number of Participants Analyzed 42 40 42 37 41
Mean (Standard Deviation)
Unit of Measure: mmHg
-2.0  (9.97) 0.5  (12.21) -2.7  (9.12) 0.6  (9.31) -3.5  (9.29)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 1.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.1843
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 4.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.4411
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 1.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.6991
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 4.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.3721
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
13.Secondary Outcome
Title Change in Inflammatory Markers
Hide Description hs-C-Reactive Protein (CRP) levels was examined by standard blood chemistry.
Time Frame Baseline to Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
Descriptive Statistics for Secondary Endpoint – hs-C-Reactive Protein Change from Baseline to day 168 (Per-Protocol Population).
Arm/Group Title Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
Hide Arm/Group Description:
Placebo: Placebo

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID

Metformin: Metformin 500 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID

Metformin: Metformin 500 mg BID

Overall Number of Participants Analyzed 42 40 42 37 41
Mean (Standard Deviation)
Unit of Measure: mg/L
0.90  (2.401) 0.12  (3.633) 0.35  (3.385) 0.56  (6.624) 0.12  (3.551)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 1.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.0318
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 4.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.3827
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 1.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.0050
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 4.0mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.
Statistical Test of Hypothesis P-Value 0.1045
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame 6 months
Adverse Event Reporting Description Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.
 
Arm/Group Title Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
Hide Arm/Group Description Placebo: Placebo

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID

Metformin: Metformin 500 mg BID

3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil

Leucine: 1100 mg BID

Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID

Metformin: Metformin 500 mg BID

All-Cause Mortality
Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/52 (0.00%)      0/51 (0.00%)      0/53 (0.00%)      0/50 (0.00%)      0/52 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/52 (0.00%)      2/51 (3.92%)      0/53 (0.00%)      1/50 (2.00%)      0/52 (0.00%)    
Infections and infestations           
Tooth abscess   0/52 (0.00%)  0 1/51 (1.96%)  1 0/53 (0.00%)  0 0/50 (0.00%)  0 0/52 (0.00%)  0
Metabolism and nutrition disorders           
Hypokalaemia   0/52 (0.00%)  0 1/51 (1.96%)  1 0/53 (0.00%)  0 0/50 (0.00%)  0 0/52 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Anal Cancer   0/52 (0.00%)  0 1/51 (1.96%)  1 0/53 (0.00%)  0 0/50 (0.00%)  0 0/52 (0.00%)  0
Metastatic malignant melanoma   0/52 (0.00%)  0 0/51 (0.00%)  0 0/53 (0.00%)  0 1/50 (2.00%)  1 0/52 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/52 (26.92%)      19/51 (37.25%)      12/53 (22.64%)      21/50 (42.00%)      19/52 (36.54%)    
Blood and lymphatic system disorders           
C-reactive protein increased   1/52 (1.92%)  1 0/51 (0.00%)  0 0/53 (0.00%)  0 0/50 (0.00%)  0 3/52 (5.77%)  3
Hypertension   3/52 (5.77%)  3 0/51 (0.00%)  0 0/53 (0.00%)  0 0/50 (0.00%)  0 0/52 (0.00%)  0
Gastrointestinal disorders           
Abdominal Pain   1/52 (1.92%)  1 0/51 (0.00%)  0 1/53 (1.89%)  1 3/50 (6.00%)  3 1/52 (1.92%)  1
General disorders           
Headache   4/52 (7.69%)  4 6/51 (11.76%)  6 0/53 (0.00%)  0 4/50 (8.00%)  4 5/52 (9.62%)  5
Increased Appetite   2/52 (3.85%)  2 4/51 (7.84%)  4 2/53 (3.77%)  2 2/50 (4.00%)  2 3/52 (5.77%)  3
Influenza   0/52 (0.00%)  0 1/51 (1.96%)  1 2/53 (3.77%)  2 3/50 (6.00%)  3 0/52 (0.00%)  0
Nausea   1/52 (1.92%)  1 4/51 (7.84%)  4 1/53 (1.89%)  1 4/50 (8.00%)  4 6/52 (11.54%)  6
Nasopharyngitis   1/52 (1.92%)  1 5/51 (9.80%)  5 0/53 (0.00%)  0 1/50 (2.00%)  1 2/52 (3.85%)  2
Pharyngitis   0/52 (0.00%)  0 3/51 (5.88%)  3 0/53 (0.00%)  0 0/50 (0.00%)  0 0/52 (0.00%)  0
Sinusitis   1/52 (1.92%)  1 0/51 (0.00%)  0 0/53 (0.00%)  0 0/50 (0.00%)  0 4/52 (7.69%)  4
Viral infection   2/52 (3.85%)  2 3/51 (5.88%)  3 3/53 (5.66%)  3 2/50 (4.00%)  2 1/52 (1.92%)  1
Musculoskeletal and connective tissue disorders           
Arthralgia   0/52 (0.00%)  0 4/51 (7.84%)  4 0/53 (0.00%)  0 0/50 (0.00%)  0 0/52 (0.00%)  0
Back Pain   0/52 (0.00%)  0 0/51 (0.00%)  0 1/53 (1.89%)  1 3/50 (6.00%)  3 1/52 (1.92%)  1
Renal and urinary disorders           
Constipation   3/52 (5.77%)  3 2/51 (3.92%)  2 1/53 (1.89%)  1 1/50 (2.00%)  1 1/52 (1.92%)  1
Diarrhoea   1/52 (1.92%)  1 2/51 (3.92%)  2 4/53 (7.55%)  4 21/50 (42.00%)  21 12/52 (23.08%)  12
Respiratory, thoracic and mediastinal disorders           
Upper respiratory tract infection   5/52 (9.62%)  5 6/51 (11.76%)  6 2/53 (3.77%)  2 4/50 (8.00%)  4 4/52 (7.69%)  4
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Barbara Cannon
Organization: NuSirt Biopharma
Phone: 6156567898
Responsible Party: NuSirt Biopharma
ClinicalTrials.gov Identifier: NCT03364335     History of Changes
Other Study ID Numbers: NS-WM-01
First Submitted: November 30, 2017
First Posted: December 6, 2017
Results First Submitted: October 29, 2018
Results First Posted: November 27, 2018
Last Update Posted: December 18, 2018