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A Study to Evaluate BMS-986036 in Obese Adults With Type-2 Diabetes

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: NCT02097277
Recruitment Status : Completed
First Posted : March 27, 2014
Results First Posted : May 9, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to assess the potential of BMS-986036 for treatment obese adults with type-2 diabetes.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Biological: BMS-986036 Biological: Placebo (Matching with BMS-986036) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 219 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Effects of BMS-986036 in Obese Adults With Type-2 Diabetes
Actual Study Start Date : April 15, 2014
Actual Primary Completion Date : September 22, 2015
Actual Study Completion Date : May 17, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Treatment A: Placebo (Matching with BMS-986036 - Daily)
Placebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks
Biological: Placebo (Matching with BMS-986036)
Experimental: Arm 2: Treatment B: BMS-986036 (1 mg Daily)
BMS-986036 1 mg subcutaneous injection once daily for 12 weeks
Biological: BMS-986036
Experimental: Treatment C: BMS-986036 (5 mg Daily)
BMS-986036 5 mg subcutaneous injection once daily for 12 weeks
Biological: BMS-986036
Experimental: Treatment D: BMS-986036 (20 mg Daily)
BMS-986036 20 mg subcutaneous injection once daily for 12 weeks
Biological: BMS-986036
Experimental: Treatment E: BMS-986036 (20 mg Weekly)

BMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks

Followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks

Biological: BMS-986036
Biological: Placebo (Matching with BMS-986036)



Primary Outcome Measures :
  1. Percent Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 12 [ Time Frame: Baseline (Day 1) and Week 12 ]
    HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Percent Change in Glycosylated Hemoglobin A1c (HbA1c) from Baseline to Week 12 was reported.


Secondary Outcome Measures :
  1. Change in Body Weight From Baseline to Week 12 [ Time Frame: Baseline (Day 1) and Week 12 ]
    Change in Body Weight from Baseline to Week 12 as a part of Physical measurement was reported.

  2. Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Composite Index of Insulin Sensitivity (CISI) (Matsuda Index) [ Time Frame: Baseline (Day 1) and Week 12 ]
    Whole body insulin sensitivity as quantified by Matsuda Index at the end of the treatment period, calculated by the following equation: 10,000/square root of(FPG*FI)*(FPG+PG30*2+PG60*3+PG120*2)/8*(FPI+PI30*2+PI60*3+PI120*2)/8). FPG=fasting plasma glucose level; FPI=fasting plasma insulin level; PG30,60,90, and 120=plasma glucose levels sampled at 30,60, and 120 minutes after oral glucose load; PI30,60,and 120=plasma insulin levels sampled at 30,60 and 120 minutes after the oral glucose load.

  3. Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) [ Time Frame: Baseline (Day 1) and Week 12 ]
    Homeostasis model assessment of insulin resistance (HOMA-IR) was used as a validated measure of insulin resistance. HOMA-IR is calculated using the following formula's fasting glucose(mg/dL) x fasting insulin(mU/L) / 405.

  4. Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Quantitative Insulin Sensitivity Check Index (QUICKI) [ Time Frame: Baseline (Day 1) and Week 12 ]
    The Quantitative Insulin Sensitivity Check Index (QUICKI) score, measures insulin sensitivity which is the inverse of insulin resistance. QUICKI is derived using the inverse of the sum of the logarithms of the fasting insulin and fasting glucose: 1 / (log(fasting insulin mU/L) + log(fasting glucose mg/dL)).

  5. Change in Oral Glucose Tolerance Test (OGTT) Area Under the Curve From 0 to 2 Hours for Postprandial Glucose From Baseline to Week 12 [ Time Frame: Baseline (Day 1) and Week 12 ]
    Blood samples were drawn after an overnight fast and standard OGTT from 0 to 120 minutes. Plasma Glucose levels over 2 hours were shown as Area Under the Curve, (AUC).

  6. Change in OGTT Insulin AUC (0-2 Hours) From Baseline to Week 12 [ Time Frame: Bseline (Day 1) and Week 12 ]
    Blood samples were drawn after an overnight fast and standard OGTT from 0 to 120 minutes. Insulin levels over 2 hours were shown as Area Under the Curve, (AUC).

  7. Change in OGTT C-peptide AUC (0-2 Hours) From Baseline to Week 12 [ Time Frame: Baseline (Day 1) and Week 12 ]
    Blood samples were drawn after an overnight fast and standard OGTT from 0 to 120 minutes. C-peptide levels over 2 hours were shown as Area Under the Curve, (AUC).

  8. Average Concentration (Cavg) of C-terminal Intact BMS-986036 [ Time Frame: Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126) ]
    Cavg of C-terminal Intact BMS-986036 was reported.

  9. Maximum Observed Concentration (Cmax) of C-terminal Intact BMS-986036 [ Time Frame: Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126) ]
    Maximum observed concentration (Cmax) of C-terminal Intact BMS-986036 was reported.

  10. Area Under the Concentration-time Curve From Time Zero to 24 Hours at Steady State (AUC [0-24 Hours, ss]) of C-terminal Intact BMS-986036 [ Time Frame: Pre-dose, 6, 24 hours postdose on Week 8 ]
    AUC [0-24 hours, ss] of C-terminal Intact BMS-986036 was reported.

  11. Area Under the Concentration-time Curve From Time Zero to 168 Hours at Steady State (AUC [0-168 Hours, ss]) of C-terminal Intact BMS-986036 [ Time Frame: Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126) ]
    AUC [0-168 hours, ss] of C-terminal Intact BMS-986036 was reported.

  12. Average Concentration (Cavg) of Total BMS-986036 [ Time Frame: Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126) ]
    Cavg of Total BMS-986036 was reported.

  13. Maximum Observed Concentration (Cmax) of Total BMS-986036 [ Time Frame: Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126) ]
    Maximum observed concentration (Cmax) of Total BMS-986036 was reported.

  14. Area Under the Concentration-time Curve From Time Zero to 24 Hours at Steady State (AUC [0-24 Hours, ss]) Total BMS-986036 [ Time Frame: Pre-dose, 6, 24 hours postdose on Week 8 ]
    AUC [0-24 hours, ss] of Total BMS-986036 was reported.

  15. Area Under the Concentration-time Curve From Time Zero to 168 Hours at Steady State (AUC [0-168 Hours, ss]) of Total BMS-986036 [ Time Frame: Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126) ]
    AUC [0-168 hours, ss] of Total BMS- 986036 was reported.

  16. Percentage of Participants With ANTI-BMS-986036 Antibody Response [ Time Frame: Baseline and Day 126 ]
    Percentage of Participants with ANTI-BMS-986036 Antibody Response (ADA positive and ADA Negative) was reported. Participants were monitored for antibodies to BMS-986036 with an anti-BMS-986036 antibody assay. Titers were reported for samples testing positive in an assay.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Diagnosed with type-2 diabetes mellitus with HbA1c ≥6.5% to less than 10.0%
  • Body mass index 30.0 to 50.0

Exclusion Criteria:

  • Any significant acute or chronic medical illness
  • Inability to self-administer subcutaneous injections
  • Inability to be venipunctured
  • Evidence of organ dysfunction beyond what is consistent with the target population
  • History of allergy to PEGylated compounds or Fibroblast growth factor 21 (FGF21) related compounds

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02097277


Locations
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United States, Arkansas
Arkansas Clinical Research
Little Rock, Arkansas, United States, 72205
United States, California
Anaheim Clinical Trials Llc
Anaheim, California, United States, 92801
National Research Institute
Los Angeles, California, United States, 90057
Encompass Clinical Research
Spring Valley, California, United States, 91978-1522
Encompass Clinical Research
Spring Valley, California, United States, 91978
United States, Florida
All Medical Research, Llc
Cooper City, Florida, United States, 33024
United States, Kentucky
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States, 40509
United States, New Jersey
Premier Research
Trenton, New Jersey, United States, 08611
United States, North Carolina
Metrolina Internal Medicine
Charlotte, North Carolina, United States, 28204
United States, Ohio
Sterling Research Grp, Ltd.
Cincinnati, Ohio, United States, 45219
Canada, British Columbia
Manna Research Vancouver
Vancouver, British Columbia, Canada, V6J 1S3
Canada, Ontario
Aggarwal And Associates
Brampton, Ontario, Canada, L6T 0G1
Canada, Quebec
Rhodin Recherche Clinique
Drummondville, Quebec, Canada, J2B 7T1
Recherche Gcp Research
Montreal, Quebec, Canada, H1M 1B1
Medexa Recherche
Victoriaville, Quebec, Canada, G6P 6P6
Canada
Alpha-Recherche Clinique
Quebec, Canada, G3K 2P8
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02097277    
Other Study ID Numbers: MB130-002
First Posted: March 27, 2014    Key Record Dates
Results First Posted: May 9, 2019
Last Update Posted: July 31, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases