Clinical trial NCT02097277: A Study to Evaluate BMS-986036 in Obese Adults With Type-2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-03-27
Enrollment: 219
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Percent Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 12
timeFrame: Baseline (Day 1) and Week 12
Secondary outcomes:
measure: Change in Body Weight From Baseline to Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Composite Index of Insulin Sensitivity (CISI) (Matsuda Index)
timeFrame: Baseline (Day 1) and Week 12
measure: Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
timeFrame: Baseline (Day 1) and Week 12
measure: Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Quantitative Insulin Sensitivity Check Index (QUICKI)
timeFrame: Baseline (Day 1) and Week 12
measure: Change in Oral Glucose Tolerance Test (OGTT) Area Under the Curve From 0 to 2 Hours for Postprandial Glucose From Baseline to Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: Change in OGTT Insulin AUC (0-2 Hours) From Baseline to Week 12
timeFrame: Bseline (Day 1) and Week 12
measure: Change in OGTT C-peptide AUC (0-2 Hours) From Baseline to Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: Average Concentration (Cavg) of C-terminal Intact BMS-986036
timeFrame: 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)
measure: Maximum Observed Concentration (Cmax) of C-terminal Intact BMS-986036
timeFrame: 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)
measure: 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
timeFrame: Pre-dose, 6, 24 hours postdose on Week 8
measure: 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
timeFrame: 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)
measure: Average Concentration (Cavg) of Total BMS-986036
timeFrame: 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)
measure: Maximum Observed Concentration (Cmax) of Total BMS-986036
timeFrame: 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)
measure: Area Under the Concentration-time Curve From Time Zero to 24 Hours at Steady State (AUC [0-24 Hours, ss]) Total BMS-986036
timeFrame: Pre-dose, 6, 24 hours postdose on Week 8
measure: Area Under the Concentration-time Curve From Time Zero to 168 Hours at Steady State (AUC [0-168 Hours, ss]) of Total BMS-986036
timeFrame: 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)
measure: Percentage of Participants With ANTI-BMS-986036 Antibody Response
timeFrame: Baseline and Day 126
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Clinical Research
state: Arkansas
city: Anaheim
country: United States
facility: Anaheim Clinical Trials Llc
state: California
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Cooper City
country: United States
facility: All Medical Research, Llc
state: Florida
city: Lexington
country: United States
facility: Central Kentucky Research Associates, Inc.
state: Kentucky
city: Trenton
country: United States
facility: Premier Research
state: New Jersey
city: Charlotte
country: United States
facility: Metrolina Internal Medicine
state: North Carolina
city: Cincinnati
country: United States
facility: Sterling Research Grp, Ltd.
state: Ohio
city: Vancouver
country: Canada
facility: Manna Research Vancouver
state: British Columbia
city: Brampton
country: Canada
facility: Aggarwal And Associates
state: Ontario
city: Drummondville
country: Canada
facility: Rhodin Recherche Clinique
state: Quebec
city: Montreal
country: Canada
facility: Recherche Gcp Research
state: Quebec
city: Victoriaville
country: Canada
facility: Medexa Recherche
state: Quebec
city: Quebec
country: Canada
facility: Alpha-Recherche Clinique
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.