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Trial record 65 of 1019 for:    Area Under Curve AND insulin

Glargine Versus NPH in Patients With Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT02451917
Recruitment Status : Completed
First Posted : May 22, 2015
Results First Posted : November 7, 2017
Last Update Posted : December 20, 2017
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Type 2 Diabetes Mellitus
Chronic Kidney Disease
Interventions Drug: Glargine insulin
Drug: NPH insulin
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Glargine Insulin, Then NPH Insulin NPH Insulin, Then Glargine Insulin
Hide Arm/Group Description The initial insulin dose for those randomized to IGlar was 80% of the total daily NPH dose that was being discontinued. All of them had pre-prandial Regular insulin switched to Lispro insulin (Humalog™, Lilly, Brazil), at the same dose as in use previously. After 24 weeks, basal insulins were switched; in other words, individuals on IGlar in the first period switched to INPH, and the doses of pre-meal insulin were sustained The same total daily NPH insulin dose was maintained for those randomized to INPH. All of them had pre-prandial Regular insulin (Humulin R™, Lilly, Brazil) switched to Lispro insulin (Humalog™, Lilly, Brazil), at the same dose as in use previously. . After 24 weeks, basal insulins were switched; in other words, individuals on NPH in the first period switched to glargine insulin, and the doses of pre-meal insulin were sustained.
Period Title: First Intervention (24 Weeks)
Started 16 18
Completed 14 15
Not Completed 2 3
Reason Not Completed
Lost to Follow-up             2             0
Death             0             1
Adverse Event             0             2
Period Title: Second Intervention (24 Weeks)
Started 14 15
Completed 14 15
Not Completed 0 0
Arm/Group Title Glargine Insulin, Then NPH Insulin NPH Insulin, Then Glargine Insulin Total
Hide Arm/Group Description The initial insulin dose for those randomized to IGlar was 80% of the total daily NPH dose that was being discontinued. All of them had pre-prandial Regular insulin switched to Lispro insulin (Humalog™, Lilly, Brazil), at the same dose as in use previously. After 24 weeks, basal insulins were switched; in other words, individuals on IGlar in the first period switched to INPH, and the doses of pre-meal insulin were sustained The same total daily NPH insulin dose was maintained for those randomized to INPH. All of them had pre-prandial Regular insulin (Humulin R™, Lilly, Brazil) switched to Lispro insulin (Humalog™, Lilly, Brazil), at the same dose as in use previously. . After 24 weeks, basal insulins were switched; in other words, individuals on NPH in the first period switched to glargine insulin, and the doses of pre-meal insulin were sustained. Total of all reporting groups
Overall Number of Baseline Participants 16 18 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 18 participants 34 participants
62.8  (7.0) 60.1  (8.7) 61.4  (7.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 18 participants 34 participants
Female
4
  25.0%
7
  38.9%
11
  32.4%
Male
12
  75.0%
11
  61.1%
23
  67.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 16 participants 18 participants 34 participants
16 18 34
Duration of Diabetes  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 18 participants 34 participants
19.0  (11.7) 19.2  (7.0) 19.1  (9.4)
Body weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 16 participants 18 participants 34 participants
75.4  (11.9) 82.6  (17.4) 79.2  (15.3)
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m²
Number Analyzed 16 participants 18 participants 34 participants
28.6  (4.8) 30.4  (4.3) 29.6  (4.6)
Systolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 16 participants 18 participants 34 participants
147  (22) 136  (18) 141  (20)
Diastolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 16 participants 18 participants 34 participants
79  (12) 75  (13) 76  (12)
1.Primary Outcome
Title Difference in A1c Levels
Hide Description A1c using high performance liquid chromatography measured in percentage
Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Primary endpoint A1c was assessed using an analysis of covariance (ANOVA) model.
Arm/Group Title Glargine Insulin Period NPH Insulin Period
Hide Arm/Group Description:
This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of insulin glargine, regardless of the sequence were grouped as glargine insulin.
This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of NPH insulin, regardless of the sequence were grouped as NPH insulin.
Overall Number of Participants Analyzed 34 34
Mean (Standard Deviation)
Unit of Measure: percentage
Baseline 8.86  (1.4) 8.21  (1.3)
24 weeks treatement 7.95  (1.1) 8.44  (1.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glargine Insulin Period, NPH Insulin Period
Comments A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power to detect a mean difference of 0.7% in the primary endpoint (A1c), considering a 15% dropout rate and assuming an SD of 0.85%, and a type I error of 5%. Test for data normality (Kolmogorov–Smirnov statistics) was performed at baseline for each sequence of the therapy.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18randomized to sequence INPH/IGlar) provided 90% power to detect a mean difference of 0.7% in the primary endpoint(A1c), considering a 15% dropout rate and assuming an SD of 0.85%, and a type I error of 5%.
Statistical Test of Hypothesis P-Value 0.00045
Comments The intention-to-treat population consisted of all randomized participants.
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Number of Hypoglycemic Events
Hide Description Hypoglycemia was defined by capillary glycemia< 70 mg/dL (3.9 mmol/L), even if it was not accompanied by typical symptoms. Otherwise, hypoglycemia was classified as “severe” with SMBG below 50 mg/dL (2.8 mmol/L) or when it resulted in stupor, seizure, or unconsciousness that precluded self-treatment, thus requiring the assistance of another individual. Nocturnal events were defined as SMBG < 70mg/dL occurring after midnight and before wake-up in the morning (before 7:00am)12.
Time Frame between 1rst and 24 weeks of each treatment arm
Hide Outcome Measure Data
Hide Analysis Population Description
Endpoint hypoglycemia was assessed using an analysis of covariance (ANOVA) model
Arm/Group Title Glargine Insulin Period NPH Insulin Period
Hide Arm/Group Description:
This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of insulin glargine, regardless of the sequence were grouped as glargine insulin.
This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of NPH insulin, regardless of the sequence were grouped as NPH insulin.
Overall Number of Participants Analyzed 34 34
Mean (Standard Deviation)
Unit of Measure: events per patients during 24 weeks
total hypoglycemic events 4.87  (5.39) 6.34  (9.37)
nocturnal hypoglycemias 0.52  (1.03) 1.52  (2.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glargine Insulin Period, NPH Insulin Period
Comments Analysis of covariance (ANOVA) model - total hypoglycemic events per patient during 24 weeks
Type of Statistical Test Non-Inferiority or Equivalence
Comments A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%. Test for data normality (Kolmogorov–Smirnov statistics) was performed at baseline for each sequence of the therapy.
Statistical Test of Hypothesis P-Value 0.35
Comments Analysis of covariance (ANOVA) model - total hypoglycemic events per patient during 24 weeks
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter number of total events per patient
Estimated Value 0
Estimation Comments The calculated value for the estimation parameter was zero, since the best treatment option for those with diabetes is reach a good glycemic control without hypoglycemia.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Glargine Insulin Period, NPH Insulin Period
Comments A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.
Statistical Test of Hypothesis P-Value 0.047
Comments Analysis of covariance (ANOVA) model - number of nocturnal hypoglycemic events per patient during 24 weeks
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter number of nocturnal events per patient
Estimated Value 0
Estimation Comments The calculated value for the estimation parameter was zero, since the best treatment option for those with diabetes is reach a good glycemic control without hypoglycemia.
3.Other Pre-specified Outcome
Title Glycemic Variability
Hide Description In order to observe variability in interstitial glucose levels related to the therapy in use, participants wore a blinded CGM for 3 days. Changes in glycemic patterns were expressed by the average daily time spent in hypoglycemia (≤70 mg/dL or <3.9 mmol/L), hyperglycemia (>180 mg/dL or >10 mmol/L) and euglycemia (70-180 mg/dL or 3.9–10 mmol/L).
Time Frame 24 week
Hide Outcome Measure Data
Hide Analysis Population Description
Patients were excluded from the analysis because of unfamiliarity with mechanical procedures related to the CGM use, visual impairment or technical problems with the sensor measurement.
Arm/Group Title Glargine Insulin Period NPH Insulin Period
Hide Arm/Group Description:
This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of NPH insulin, regardless of the sequence were grouped as glargine insulin.
This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of NPH insulin, regardless of the sequence were grouped as NPH insulin.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: percentage of time
hyperglycemia 30  (19) 38  (19)
normoglycemia 67  (19) 59  (19)
hypoglycemia 3  (6) 3  (5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glargine Insulin Period, NPH Insulin Period
Comments A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.
Type of Statistical Test Non-Inferiority or Equivalence
Comments t-test was applied to compare percentages of the time spent in hypoglycemia, hyperglycemia and euglycemia on CGM readings.
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
4.Other Pre-specified Outcome
Title Total Daily Insulin Dose
Hide Description Daily total insulin dose at baseline compared to dose at week 24.
Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Randomization was stratified by the A1c value at baseline: <9.0% or ≥9.0%, in a 1:1 ratio, and the individuals who met all inclusion-criteria were allocated alternately to either an IGlar/INPH or an INPH/IGlar treatment sequence.
Arm/Group Title Glargine Insulin NPH Insulin
Hide Arm/Group Description:
This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of insulin glargine, regardless of the sequence were grouped as glargine insulin.
This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of NPH insulin, regardless of the sequence were grouped as NPH insulin.
Overall Number of Participants Analyzed 34 34
Mean (Standard Deviation)
Unit of Measure: units/Kg/day
Baseline 0.61  (0.21) 0.63  (0.21)
24 weeks treatment 0.64  (0.26) 0.64  (0.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glargine Insulin, NPH Insulin
Comments A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.
Statistical Test of Hypothesis P-Value 0.668
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
5.Other Pre-specified Outcome
Title Body Mass Index (BMI)
Hide Description The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres.
Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
BMI endpoint was assessed using an analysis of covariance (ANOVA) model.
Arm/Group Title Glargine Insulin Period NPH Insulin Period
Hide Arm/Group Description:
This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of insulin glargine, regardless of the sequence were grouped as glargine insulin.
This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of NPH insulin, regardless of the sequence were grouped as NPH insulin.
Overall Number of Participants Analyzed 34 34
Mean (Standard Deviation)
Unit of Measure: Kg/m²
Baseline 29.7  (4.7) 30.0  (4.3)
24 weeks treatement 30.0  (4.3) 30.4  (4.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glargine Insulin Period, NPH Insulin Period
Comments A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18r andomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18r andomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.
Statistical Test of Hypothesis P-Value 0.999
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
6.Other Pre-specified Outcome
Title Serum Creatinine
Hide Description Creatinine is measured in milligrams per deciliter of blood (mg/dL
Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Creatinine endpoint was assessed using an analysis of covariance (ANOVA) model.
Arm/Group Title Glargine Insulin Period NPH Insulin Period
Hide Arm/Group Description:
This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of insulin glargine, regardless of the sequence were grouped as glargine insulin.
This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of NPH insulin, regardless of the sequence were grouped as NPH insulin.
Overall Number of Participants Analyzed 34 34
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline 2.4  (0.7) 2.5  (1.0)
24 weeks treatement 2.6  (0.8) 2.6  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glargine Insulin Period, NPH Insulin Period
Comments A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.
Statistical Test of Hypothesis P-Value 0.999
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
7.Other Pre-specified Outcome
Title Estimated Glomerular Filtration Rate (eGFR) Calculated by CKD-EPI
Hide Description

Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation is one of the most widely used IDMS traceable equations for estimating GFR in patients age 18 and over. CKD-EPI equation includes variables for age, gender, and race, which may allow providers to observe that CKD is present despite a serum creatinine concentration that appears to fall within or just above the normal reference interval.

CKD-EPI equation expressed as a single equation: GFR = 141 × min (Scr /κ, 1)α × max(Scr /κ, 1)-1.209 × 0.993Age × 1.018 [if female] × 1.159 [if black] where: Scr is serum creatinine in mg/dL, κ is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males,min indicates the minimum of Scr /κ or 1, and max indicates the maximum of Scr /κ or 1.

Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glargine Insulin Period NPH Insulin Period
Hide Arm/Group Description:
This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of insulin glargine, regardless of the sequence were grouped as glargine insulin.
This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of NPH insulin, regardless of the sequence were grouped as NPH insulin.
Overall Number of Participants Analyzed 34 34
Mean (Standard Deviation)
Unit of Measure: ml/min/1.7m²
Baseline 28.0  (9.6) 27.4  (9.1)
24 weeks treatement 26.9  (10.0) 25.9  (9.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glargine Insulin Period, NPH Insulin Period
Comments A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.
Statistical Test of Hypothesis P-Value 0.994
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame 1 year
Adverse Event Reporting Description hypoglycemia was classified as “severe” with SMBG below 50 mg/dL (2.8 mmol/L) or when it resulted in stupor, seizure, or unconsciousness that precluded self-treatment, thus requiring the assistance of another individual.
 
Arm/Group Title Glargine Insulin NPH Insulin
Hide Arm/Group Description

This is an open-label, randomized, two-way crossover study , one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of insulin glargine, regardless of the sequence were grouped as glargine.

Glargine insulin: The initial insulin dose for those randomized to IGlar was 80% of the total daily NPH dose that was being discontinued. All of them had pre-prandial Regular insulin switched to Lispro insulin (Humalog™, Lilly, Brazil), at the same dose as in use previously. After 24 weeks, basal insulins were switched; in other words, individuals on IGlar in the first period switched to INPH, and the doses of pre-meal insulin were sustained

This is an open-label, randomized, two-way crossover study , one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin.

At the end of the study, all data acquired during the use of NPH insulin, regardless of the sequence were grouped as NPH.

NPH insulin: The same total daily NPH insulin dose was maintained for those randomized to INPH. All of them had pre-prandial Regular insulin (Humulin R™, Lilly, Brazil) switched to Lispro insulin (Humalog™, Lilly, Brazil), at the same dose as in use previously. . After 24 weeks, basal insulins were switched; in other words, individuals on NPH in the first period switched to glargine insulin, and the doses of pre-meal insulin were sustained.

All-Cause Mortality
Glargine Insulin NPH Insulin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Glargine Insulin NPH Insulin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/34 (0.00%)      2/34 (5.88%)    
Nervous system disorders     
Severe hypoglycemia  [1]  0/34 (0.00%)  0 2/34 (5.88%)  2
Indicates events were collected by systematic assessment
[1]
stupor, seizure, or unconsciousness that precluded self-treatment, thus requiring the assistance of another individual
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Glargine Insulin NPH Insulin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/34 (0.00%)      0/34 (0.00%)    
The results only apply to patients with T2DM and DKD stages 3 and 4 and do not allow us to extrapolate any conclusion to those on dialysis or initial stages of DKD. The patients were randomized alternately, in accordance with the initial A1c.
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
Name/Title: Marcia Silva Queiroz, MD, PhD
Organization: Endocrinology Division, University of São Paulo Medical School,
Phone: + 5511 26616293
Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02451917     History of Changes
Other Study ID Numbers: ENDONEFRO
First Submitted: August 25, 2014
First Posted: May 22, 2015
Results First Submitted: October 20, 2016
Results First Posted: November 7, 2017
Last Update Posted: December 20, 2017