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Completed

NCT Number: NCT02097277

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

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

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Manna Research Vancouver, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986036

Biological

Placebo (Matching with BMS-986036)

Biological

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Mar 27, 2014
Registry last updated
Jul 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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