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

Phase 2CompletedNCT02097277

Bristol-Myers Squibb219 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

219

Conditions

Diabetes Mellitus Type 2

Interventions

BMS-986036BIOLOGICAL

Placebo (Matching with BMS-986036)BIOLOGICAL

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (16)

Arkansas Clinical Research

Little Rock, Arkansas, United States

Anaheim Clinical Trials Llc

Anaheim, California, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline (Day 1) and Week 12

Secondary Outcomes

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.

Time frame: 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)

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.

Time frame: 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)

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.

Time frame: Baseline (Day 1) and Week 12

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)).

Data from ClinicalTrials.gov

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National Research Institute

Los Angeles, California, United States

Encompass Clinical Research

Spring Valley, California, United States

Encompass Clinical Research

Spring Valley, California, United States

All Medical Research, Llc

Cooper City, Florida, United States

Central Kentucky Research Associates, Inc.

Lexington, Kentucky, United States

Premier Research

Trenton, New Jersey, United States

Metrolina Internal Medicine

Charlotte, North Carolina, United States

Sterling Research Grp, Ltd.

Cincinnati, Ohio, United States

...and 6 more locations

Time frame: 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

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).

Time frame: Baseline (Day 1) and Week 12

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).

Time frame: Bseline (Day 1) and Week 12

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).

Time frame: Baseline (Day 1) and Week 12

Average Concentration (Cavg) of C-terminal Intact BMS-986036

Cavg of C-terminal Intact BMS-986036 was reported.

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

Maximum observed concentration (Cmax) of C-terminal Intact BMS-986036 was reported.

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)

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.

Time frame: Pre-dose, 6, 24 hours postdose on Week 8

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.

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)

Average Concentration (Cavg) of Total BMS-986036

Cavg of Total BMS-986036 was reported.

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

Maximum observed concentration (Cmax) of Total BMS-986036 was reported.

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)

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.

Time frame: Pre-dose, 6, 24 hours postdose on Week 8

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.

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)

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.

Time frame: Baseline and Day 126