A Study to Evaluate BMS-986036 in Obese Adults With Type-2 Diabetes
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
1 other identifier
interventional
219
2 countries
16
Brief Summary
The purpose of this study is to assess the potential of BMS-986036 for treatment obese adults with type-2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 diabetes-mellitus-type-2
Started Apr 2014
Typical duration for phase_2 diabetes-mellitus-type-2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2014
CompletedFirst Posted
Study publicly available on registry
March 27, 2014
CompletedStudy Start
First participant enrolled
April 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 17, 2016
CompletedResults Posted
Study results publicly available
May 9, 2019
CompletedJuly 31, 2019
July 1, 2019
1.4 years
March 19, 2014
March 14, 2019
July 29, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to 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.
Baseline (Day 1) and Week 12
Secondary Outcomes (16)
Change in Body Weight From Baseline to Week 12
Baseline (Day 1) and Week 12
Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Composite Index of Insulin Sensitivity (CISI) (Matsuda Index)
Baseline (Day 1) and Week 12
Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Baseline (Day 1) and Week 12
Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Quantitative Insulin Sensitivity Check Index (QUICKI)
Baseline (Day 1) and Week 12
Change in Oral Glucose Tolerance Test (OGTT) Area Under the Curve From 0 to 2 Hours for Postprandial Glucose From Baseline to Week 12
Baseline (Day 1) and Week 12
- +11 more secondary outcomes
Study Arms (5)
Treatment A: Placebo (Matching with BMS-986036 - Daily)
PLACEBO COMPARATORPlacebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks
Arm 2: Treatment B: BMS-986036 (1 mg Daily)
EXPERIMENTALBMS-986036 1 mg subcutaneous injection once daily for 12 weeks
Treatment C: BMS-986036 (5 mg Daily)
EXPERIMENTALBMS-986036 5 mg subcutaneous injection once daily for 12 weeks
Treatment D: BMS-986036 (20 mg Daily)
EXPERIMENTALBMS-986036 20 mg subcutaneous injection once daily for 12 weeks
Treatment E: BMS-986036 (20 mg Weekly)
EXPERIMENTALBMS-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
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosed with type-2 diabetes mellitus with HbA1c ≥6.5% to less than 10.0%
- Body mass index 30.0 to 50.0
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Arkansas Clinical Research
Little Rock, Arkansas, 72205, United States
Anaheim Clinical Trials Llc
Anaheim, California, 92801, United States
National Research Institute
Los Angeles, California, 90057, United States
Encompass Clinical Research
Spring Valley, California, 91978-1522, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
All Medical Research, Llc
Cooper City, Florida, 33024, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509, United States
Premier Research
Trenton, New Jersey, 08611, United States
Metrolina Internal Medicine
Charlotte, North Carolina, 28204, United States
Sterling Research Grp, Ltd.
Cincinnati, Ohio, 45219, United States
Manna Research Vancouver
Vancouver, British Columbia, V6J 1S3, Canada
Aggarwal And Associates
Brampton, Ontario, L6T 0G1, Canada
Rhodin Recherche Clinique
Drummondville, Quebec, J2B 7T1, Canada
Recherche Gcp Research
Montreal, Quebec, H1M 1B1, Canada
Alpha-Recherche Clinique
Québec, Quebec, G3K 2P8, Canada
Medexa Recherche
Victoriaville, Quebec, G6P 6P6, Canada
Related Publications (1)
Charles ED, Neuschwander-Tetri BA, Pablo Frias J, Kundu S, Luo Y, Tirucherai GS, Christian R. Pegbelfermin (BMS-986036), PEGylated FGF21, in Patients with Obesity and Type 2 Diabetes: Results from a Randomized Phase 2 Study. Obesity (Silver Spring). 2019 Jan;27(1):41-49. doi: 10.1002/oby.22344. Epub 2018 Dec 6.
PMID: 30520566DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2014
First Posted
March 27, 2014
Study Start
April 15, 2014
Primary Completion
September 22, 2015
Study Completion
May 17, 2016
Last Updated
July 31, 2019
Results First Posted
May 9, 2019
Record last verified: 2019-07