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

Diabetes Mellitus Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02097277
• Other study ID #: MB130-002
• Status: Completed
• Phase: Phase 2
• Start date: April 15, 2014
• Est. completion date: May 17, 2016

Study information

• Verified date: July 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: May 17, 2016
• Est. primary completion date: September 22, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Biological:
• BMS-986036

• Placebo (Matching with BMS-986036)

Locations

Country	Name	City	State
Canada	Aggarwal And Associates	Brampton	Ontario
Canada	Rhodin Recherche Clinique	Drummondville	Quebec
Canada	Recherche Gcp Research	Montreal	Quebec
Canada	Alpha-Recherche Clinique	Quebec
Canada	Manna Research Vancouver	Vancouver	British Columbia
Canada	Medexa Recherche	Victoriaville	Quebec
United States	Anaheim Clinical Trials Llc	Anaheim	California
United States	Metrolina Internal Medicine	Charlotte	North Carolina
United States	Sterling Research Grp, Ltd.	Cincinnati	Ohio
United States	All Medical Research, Llc	Cooper City	Florida
United States	Central Kentucky Research Associates, Inc.	Lexington	Kentucky
United States	Arkansas Clinical Research	Little Rock	Arkansas
United States	National Research Institute	Los Angeles	California
United States	Encompass Clinical Research	Spring Valley	California
United States	Encompass Clinical Research	Spring Valley	California
United States	Premier Research	Trenton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Body Weight From Baseline to Week 12	Change in Body Weight from Baseline to Week 12 as a part of Physical measurement was reported.	Baseline (Day 1) and Week 12
Secondary	Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Composite Index of Insulin Sensitivity (CISI) (Matsuda Index)	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.	Baseline (Day 1) and Week 12
Secondary	Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)	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.	Baseline (Day 1) and Week 12
Secondary	Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Quantitative Insulin Sensitivity Check Index (QUICKI)	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)).	Baseline (Day 1) and Week 12
Secondary	Change in Oral Glucose Tolerance Test (OGTT) Area Under the Curve From 0 to 2 Hours for Postprandial Glucose From Baseline to 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).	Baseline (Day 1) and Week 12
Secondary	Change in OGTT Insulin AUC (0-2 Hours) From Baseline to 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).	Bseline (Day 1) and Week 12
Secondary	Change in OGTT C-peptide AUC (0-2 Hours) From Baseline to 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).	Baseline (Day 1) and Week 12
Secondary	Average Concentration (Cavg) of C-terminal Intact BMS-986036	Cavg of C-terminal Intact BMS-986036 was reported.	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)
Secondary	Maximum Observed Concentration (Cmax) of C-terminal Intact BMS-986036	Maximum observed concentration (Cmax) of C-terminal Intact BMS-986036 was reported.	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)
Secondary	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	AUC [0-24 hours, ss] of C-terminal Intact BMS-986036 was reported.	Pre-dose, 6, 24 hours postdose on Week 8
Secondary	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	AUC [0-168 hours, ss] of C-terminal Intact BMS-986036 was reported.	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)
Secondary	Average Concentration (Cavg) of Total BMS-986036	Cavg of Total BMS-986036 was reported.	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)
Secondary	Maximum Observed Concentration (Cmax) of Total BMS-986036	Maximum observed concentration (Cmax) of Total BMS-986036 was reported.	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)
Secondary	Area Under the Concentration-time Curve From Time Zero to 24 Hours at Steady State (AUC [0-24 Hours, ss]) Total BMS-986036	AUC [0-24 hours, ss] of Total BMS-986036 was reported.	Pre-dose, 6, 24 hours postdose on Week 8
Secondary	Area Under the Concentration-time Curve From Time Zero to 168 Hours at Steady State (AUC [0-168 Hours, ss]) of Total BMS-986036	AUC [0-168 hours, ss] of Total BMS- 986036 was reported.	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)
Secondary	Percentage of Participants With ANTI-BMS-986036 Antibody Response	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.	Baseline and Day 126

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