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Trial record 61 of 547 for:    INSULIN ASPART

Effect of a Basal/Pre-Meal Insulin Strategy (Detemir/Aspart) on Insulin Secretion and Action in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00998335
Recruitment Status : Completed
First Posted : October 20, 2009
Results First Posted : July 29, 2016
Last Update Posted : September 28, 2016
Sponsor:
Collaborators:
VA Office of Research and Development
Novo Nordisk A/S
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 2 Diabetes
Interventions Drug: Long-acting bedtime insulin detemir (Levemir)
Drug: Insulin detemir and pre-meal insulin aspart.
Enrollment 30
Recruitment Details Clinical Research Unit
Pre-assignment Details All participants started in the "Insulin detemir only" arm. At week 12 the participants were randomized in a 2:1 ratio to either Insulin detemir only arm or to Insulin detemir plus aspart.
Arm/Group Title Insulin Detemir Only Insulin Detemir Plus Aspart
Hide Arm/Group Description

Patients with uncontrolled T2DM are treated with insulin detemir for 6 months

Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.

After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.

Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner.

Period Title: Initial Treatment (Months 0 - 3)
Started 30 0
Completed 30 0
Not Completed 0 0
Period Title: Randomized Period (Months 3 to 6)
Started 8 [1] 22 [1]
Completed 8 20
Not Completed 0 2
Reason Not Completed
Withdrawal by Subject             0             2
[1]
All participants started in the "Insulin detemir only" arm. At month 3 subjects were randomized 2:1.
Arm/Group Title Insulin Detemir Only Insulin Detemir Plus Aspart Total
Hide Arm/Group Description

Patients with uncontrolled T2DM are treated with insulin detemir for 6 months

Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.

After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.

Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner.

Total of all reporting groups
Overall Number of Baseline Participants 8 22 30
Hide Baseline Analysis Population Description
All participants were started in the "Insulin detemir only" arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 22 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
 100.0%
22
 100.0%
30
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 22 participants 30 participants
50  (8) 59  (8) 57  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 22 participants 30 participants
Female
0
   0.0%
3
  13.6%
3
  10.0%
Male
8
 100.0%
19
  86.4%
27
  90.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 22 participants 30 participants
8 22 30
1.Primary Outcome
Title Hepatic Steatosis
Hide Description Hepatic steatosis measured by proton magnetic resonance spectroscopy (1H-MRS).
Time Frame 3 and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
In six patients liver MRS was not possible due to claustrophobia, metal parts, or too large for MRI scanner. N=30 participants in the Insulin detemir x 3 months, N=8 participants in the Insulin Detemir alone and 22 in the Detemir Plus Aspart at 6 months.
Arm/Group Title Insulin Detemir x 3 Months (All Pts Had Liver MRS) Insulin Detemir Plus Aspart
Hide Arm/Group Description:
Liver fat by MRS measured after 3 months of insulin.

After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.

Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner.

Overall Number of Participants Analyzed 30 22
Mean (Standard Deviation)
Unit of Measure: percentage of liver fat
Month 3 6.7  (4.4) NA [1]   (NA)
Month 6 8.4  (7.2) 5.9  (4.2)
[1]
Participants were only randomized to this arm after 3 months of treatment.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Detemir x 3 Months (All Pts Had Liver MRS)
Comments Baseline versus 3 months
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Metabolic Control as Measured by the A1c
Hide Description [Not Specified]
Time Frame 3 and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were started in the "Insulin detemir only" arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms.
Arm/Group Title Insulin Detemir Only (3 and 6 Months) Insulin Detemir Plus Aspart
Hide Arm/Group Description:
All patients with uncontrolled T2DM are treated with insulin detemir for 6 months and after 3 months randomized to either arm. Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.

After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.

Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner.

Overall Number of Participants Analyzed 30 22
Mean (Standard Deviation)
Unit of Measure: percentage of A1c
3-month - A1c 7.4  (1.4) NA [1]   (NA)
6-month - A1c 6.9  (0.5) 6.7  (0.7)
[1]
Participants were not randomized into this arm until month 3.
3.Secondary Outcome
Title Change in Insulin Secretion
Hide Description Derived from the hyperglycemic clamp (Plasma C-peptide change vs. pretreatment in first and second phase).
Time Frame 3 and 6 months.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were started in the "Insulin detemir only" arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 at 3 months and N=28 at 6 months.
Arm/Group Title Insulin Detemir Only (3 and 6 Months) Insulin Detemir Plus Aspart
Hide Arm/Group Description:
All patients with uncontrolled T2DM are treated with insulin detemir for 6 months and after 3 months randomized to either arm. Long-acting bedtime insulin detemir (Levemir) is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.

After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.

Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner.

Overall Number of Participants Analyzed 30 22
Mean (Standard Deviation)
Unit of Measure: ng/ml
3-month C-peptide level increase in first phase 0.5  (1.3) NA [1]   (NA)
3-month C-peptide level increase in second phase 1.6  (2.5) NA [1]   (NA)
6-month C-peptide level increase in first phase -0.1  (0.9) 0.2  (1.4)
6-month C-peptide level increase in second phase 0.6  (2.0) 0.2  (2.3)
[1]
Participants were not randomized to this arm until month 3.
4.Secondary Outcome
Title Intramyocellular (IMCL) by Magnetic Resonance Imaging and Spectroscopy (MRS).
Hide Description Percent intramyocellular (IMCL) by magnetic resonance imaging and spectroscopy (MRS).
Time Frame 3 and 6 months.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were started in the "Insulin detemir only" arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months
Arm/Group Title Insulin Detemir Only Insulin Detemir Plus Aspart
Hide Arm/Group Description:

Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. After patients were treated for 3 months with bedtime insulin detemir they were randomized to either continue with bedtime insulin detemir or add premeal rapid-acting insulin novolog.

Long-acting bedtime insulin detemir (Levemir) was given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.

After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.

Insulin detemir was given at bedtime. Insulin aspart before breakfast, lunch and dinner.

Overall Number of Participants Analyzed 30 22
Mean (Standard Deviation)
Unit of Measure: % of intramyocellular triglyceride
3-month intramyocellular triglycerides 0.63  (0.62) NA [1]   (NA)
6-month intramyocellular triglycerides 1.05  (0.18) 0.49  (0.47)
[1]
Participants were not randomized to this arm until month 3.
5.Secondary Outcome
Title Plasma Lipid Concentration.
Hide Description Fasting plasma lipid concentration on day of admission at 3 and 6 months.
Time Frame 3 and 6 months.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were started in the "Insulin detemir only" arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months
Arm/Group Title Insulin Detemir Only Insulin Detemir Plus Aspart
Hide Arm/Group Description:

Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. After patients were treated for 3 months with bedtime insulin detemir they were randomized to either continue with bedtime insulin detemir or add premeal rapid-acting insulin novolog.

Long-acting bedtime insulin detemir (Levemir) was given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.

After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.

Insulin detemir was given at bedtime. Insulin aspart before breakfast, lunch and dinner.

Overall Number of Participants Analyzed 30 22
Mean (Standard Deviation)
Unit of Measure: mg/dL
3-month total cholesterol 136  (36) NA [1]   (NA)
3-month LDL-cholesterol 76  (27) NA [1]   (NA)
3-month triglycerides 154  (76) NA [1]   (NA)
3-month HDL-C 33  (8) NA [1]   (NA)
6-month total cholesterol 147  (31) 145  (37)
6-month LDL-cholesterol 86  (29) 80  (28)
6-month triglycerides 150  (66) 144  (62)
6-month HDL-C 31  (5) 33  (7)
[1]
Participants were not randomized to this arm until month 3.
6.Secondary Outcome
Title Change in Anthropometric Measure (Body Weight).
Hide Description Change in anthropometric measure (body weight) done on day of admission at 3 and 6 months.
Time Frame 3 and 6 months.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were started in the "Insulin detemir only" arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months
Arm/Group Title Insulin Detemir Only Insulin Detemir Plus Aspart
Hide Arm/Group Description:

Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. After patients were treated for 3 months with bedtime insulin detemir they were randomized to either continue with bedtime insulin detemir or add premeal rapid-acting insulin novolog.

Long-acting bedtime insulin detemir (Levemir) was given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.

After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.

Insulin detemir was given at bedtime. Insulin aspart before breakfast, lunch and dinner.

Overall Number of Participants Analyzed 30 22
Mean (Standard Deviation)
Unit of Measure: Change from baseline (Kg)
3-month total body weight -0.8  (7.3) NA [1]   (NA)
6-month total body weight 0.8  (1.9) 0.3  (3.5)
[1]
Participants were not randomized to this arm until month 3.
7.Secondary Outcome
Title Number of Hypoglycemic Events
Hide Description Defined as hypoglycemia <40 mg/dl and/or requiring medical assistance during the trial.
Time Frame 3 and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were started in the "Insulin detemir only" arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months
Arm/Group Title Insulin Detemir Only Insulin Detemir Plus Aspart
Hide Arm/Group Description:

Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. After patients were treated for 3 months with bedtime insulin detemir they were randomized to either continue with bedtime insulin detemir or add premeal rapid-acting insulin novolog.

Long-acting bedtime insulin detemir (Levemir) was given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.

After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.

Insulin detemir was given at bedtime. Insulin aspart before breakfast, lunch and dinner.

Overall Number of Participants Analyzed 30 22
Measure Type: Number
Unit of Measure: Number of events
3-month rate of severe hypoglycemia 0 NA [1] 
6-month rate of severe hypoglycemia 0 0
[1]
Participants were not randomized to this arm until month 3.
8.Secondary Outcome
Title Metabolic Control as Measured by the Fasting Plasma Glucose Concentration
Hide Description [Not Specified]
Time Frame 3 and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were started in the "Insulin detemir only" arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months
Arm/Group Title Insulin Detemir Only (3 and 6 Months) Insulin Detemir Plus Aspart
Hide Arm/Group Description:
All patients with uncontrolled T2DM are treated with insulin detemir for 6 months and after 3 months randomized to either arm. Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.

After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.

Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner.

Overall Number of Participants Analyzed 30 22
Mean (Standard Deviation)
Unit of Measure: mg/dL
3-month - Fasting plasma glucose 105  (38) NA [1]   (NA)
6-month - Fasting plasma glucose 89  (18) 116  (27)
[1]
Participants were not randomized to this arm until month 3.
9.Secondary Outcome
Title Metabolic Control as Measured by the Postprandial Plasma Glucose During the Day-long Plasma Glucose Profile.
Hide Description [Not Specified]
Time Frame 3 and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were started in the "Insulin detemir only" arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months
Arm/Group Title Insulin Detemir Only (3 and 6 Months) Insulin Detemir Plus Aspart
Hide Arm/Group Description:
All patients with uncontrolled T2DM are treated with insulin detemir for 6 months and after 3 months randomized to either arm. Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.

After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.

Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner.

Overall Number of Participants Analyzed 30 22
Mean (Standard Deviation)
Unit of Measure: mg/dL
3-month - Day-long plasma glucose profile 168  (44) NA [1]   (NA)
6-month - Day-long plasma glucose profile 153  (38) 170  (48)
[1]
Participants were not randomized until month 3
10.Secondary Outcome
Title Advanced Lipid Testing
Hide Description Change in lipoprotein particle number was determined using NMR.
Time Frame 3 and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin Detemir Only (3 and 6 Months) Insulin Detemir Plus Aspart
Hide Arm/Group Description:
All patients with uncontrolled T2DM are treated with insulin detemir for 6 months and after 3 months randomized to either arm. Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.

After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.

Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner.

Overall Number of Participants Analyzed 30 22
Mean (Standard Deviation)
Unit of Measure: Change in number of particles (nmol/L)
VLDL particles (3 months) -15  (39) NA [1]   (NA)
VLDL particles (6 months) -5  (38) -2  (31)
LDL particles (3 months) -100  (313) NA [1]   (NA)
LDL particles (6 months) 128  (206) 85  (209)
HDL particles (3 months) 0  (3) NA [1]   (NA)
HDL particles (6 months) 2  (4) 1  (4)
[1]
Randomization of this group occurred at month 3.
11.Secondary Outcome
Title Change in Anthropometric Measure (Body Mass Index [BMI]).
Hide Description Change in anthropometric measure (body mass index [BMI]) done on day of admission at 3 and 6 months.
Time Frame 3 and 6 months.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were started in the "Insulin detemir only" arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months
Arm/Group Title Insulin Detemir Only Insulin Detemir Plus Aspart
Hide Arm/Group Description:

Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. After patients were treated for 3 months with bedtime insulin detemir they were randomized to either continue with bedtime insulin detemir or add premeal rapid-acting insulin novolog.

Long-acting bedtime insulin detemir (Levemir) was given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.

After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.

Insulin detemir was given at bedtime. Insulin aspart before breakfast, lunch and dinner.

Overall Number of Participants Analyzed 30 22
Mean (Standard Deviation)
Unit of Measure: Change from baseline (Kg/m2)
3-month body mass index -0.4  (2.7) NA [1]   (NA)
6-month body mass index 0.3  (0.6) 0.2  (1.2)
[1]
Patients were not randomized to this arm until month 3.
12.Secondary Outcome
Title Percent Change From Baseline in Vascular Inflammatory Markers
Hide Description Inflammatory Markers include: Adiponectin, MMP-9, E-selectin, sICAM, and sVCAM
Time Frame 3 and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin Detemir Only Insulin Detemir Plus Aspart
Hide Arm/Group Description:

Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl. This group will receive Long-acting bedtime insulin detemir (Levemir).

Long-acting bedtime insulin detemir (Levemir): This group will receive Insulin detemir. Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.

After baseline evaluations, insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart (insulin detemir plus aspart) will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated. This group will receive Insulin detemir and pre-meal insulin aspart.

Insulin detemir and pre-meal insulin aspart.: This group will receive Insulin detemir plus aspart. The group will start with Insulin detemir at bedtime. Then in three months they will Insulin aspart before breakfast, lunch and dinner.

Overall Number of Participants Analyzed 30 22
Mean (Standard Deviation)
Unit of Measure: Percentage of change
Adiponectin (3 months) 18  (63) NA [1]   (NA)
Adiponectin (6 months) 65  (71) 5  (30)
MMP-9 (3 months) 32  (59) NA [1]   (NA)
MMP-9 (6 months) 30  (115) 49  (73)
E-selectin (3 months) -6  (25) NA [1]   (NA)
E-selectin (6 months) 34  (34) 19  (29)
sICAM (3 months) -4  (22) NA [1]   (NA)
sICAM (6 months) 2  (12) -1  (15)
sVCAM (3 months) 1  (8) NA [1]   (NA)
sVCAM (6 months) 14  (13) 7  (11)
[1]
Patients were not randomized to this arm until month 3.
Time Frame Up to 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Insulin Detemir Only Insulin Detemir Plus Aspart
Hide Arm/Group Description

Patients with uncontrolled T2DM are treated with insulin detemir for 6 months

Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.

After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.

Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner.

All-Cause Mortality
Insulin Detemir Only Insulin Detemir Plus Aspart
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Insulin Detemir Only Insulin Detemir Plus Aspart
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/22 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Insulin Detemir Only Insulin Detemir Plus Aspart
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/22 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Layout table for Results Point of Contact information
Name/Title: Dr. Kenneth Cusi
Organization: University of Florida
Phone: 352-273-7236
EMail: KCusi@ufl.edu
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00998335     History of Changes
Other Study ID Numbers: 20060167
First Submitted: October 19, 2009
First Posted: October 20, 2009
Results First Submitted: August 22, 2012
Results First Posted: July 29, 2016
Last Update Posted: September 28, 2016