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

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ClinicalTrials.gov Identifier: NCT02097277
Recruitment Status : Completed
First Posted : March 27, 2014
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Biological: BMS-986036 Biological: Placebo (Matching with BMS-986036) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : April 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Treatment A: Placebo (Matching with BMS-986036 - Daily)
Placebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks
Biological: Placebo (Matching with BMS-986036)
Experimental: Arm 2: Treatment B: BMS-986036 (1 mg Daily)
BMS-986036 1 mg subcutaneous injection once daily for 12 weeks
Biological: BMS-986036
Experimental: Treatment C: BMS-986036 (5 mg Daily)
BMS-986036 5 mg subcutaneous injection once daily for 12 weeks
Biological: BMS-986036
Experimental: Treatment D: BMS-986036 (20 mg Daily)
BMS-986036 20 mg subcutaneous injection once daily for 12 weeks
Biological: BMS-986036
Experimental: Treatment E: BMS-986036 (20 mg Weekly)

BMS-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

Biological: BMS-986036
Biological: Placebo (Matching with BMS-986036)



Primary Outcome Measures :
  1. Change in glycosylated hemoglobin A1c (HbA1c) from baseline to Week 12 [ Time Frame: Baseline (Day 1) and Week 12 ]
  2. Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, Electrocardiogram (ECGs), physical examinations, Dual-energy X-ray Absorptiometry (DXA) scans and clinical laboratory tests [ Time Frame: Approximately 10 months ]

Secondary Outcome Measures :
  1. Average concentration (Cavg) of BMS-986036 [ Time Frame: 13 time points up to 126 days ]
  2. Trough observed concentration (Cmin) of BMS-986036 [ Time Frame: 13 time points up to 126 days ]
  3. Maximum observed concentration (Cmax) of BMS-986036 [ Time Frame: 13 time points up to 126 days ]
  4. Area under the concentration-time curve (AUC) at steady state of BMS-986036 [ Time Frame: 13 time points up to 126 days ]
  5. Change or percent change in Body weight, Waist circumference and Body mass index (BMI) from baseline to Week 12 [ Time Frame: Baseline (Day 1) and Week 12 ]
  6. Change or percent change in Insulin sensitivity indexes, calculated from Glucose and Insulin in oral glucose tolerance test (OGTT), from baseline to Week 12 [ Time Frame: Baseline (Day 1) and Week 12 ]
    Insulin sensitivity index include Homeostatic model assessment of Insulin resistance (HOMA-IR), Quantitative Insulin sensitivity check index (QUICKI) and Matsuda Index

  7. Change or percent change in OGTT area under the curve from 0 to 120 minutes for postprandial glucose and Insulin response to an OGTT from baseline to Week 12 [ Time Frame: Baseline (Day 1) and Week 12 ]
  8. Change or percent change in fasting Plasma glucose, Serum Insulin and Serum C-peptide and glucagon from baseline to Week 12 [ Time Frame: Baseline (Day 1) and Week 12 ]
  9. Immunogenicity measures [ Time Frame: Up to 161 days ]
    Subjects will be monitored for antibodies to study medication and to FGF-21 with an anti-drug antibody assay and an anti-FGF21 assay. Titers will be reported for samples testing positive in either assay. In addition, subjects testing positive in either assay will be assessed for neutralizing antibodies with a functional cell based neutralizing antibody assay



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02097277


Locations
United States, Arkansas
Arkansas Clinical Research
Little Rock, Arkansas, United States, 72205
United States, California
Anaheim Clinical Trials Llc
Anaheim, California, United States, 92801
National Research Institute
Los Angeles, California, United States, 90057
Encompass Clinical Research
Spring Valley, California, United States, 91978
United States, Florida
All Medical Research, Llc
Cooper City, Florida, United States, 33024
United States, Kentucky
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States, 40509
United States, New Jersey
Premier Research
Trenton, New Jersey, United States, 08611
United States, North Carolina
Metrolina Internal Medicine
Charlotte, North Carolina, United States, 28204
United States, Ohio
Sterling Research Grp, Ltd.
Cincinnati, Ohio, United States, 45219
Canada, British Columbia
Manna Research Vancouver
Vancouver, British Columbia, Canada, V6J 1S3
Canada, Ontario
Aggarwal And Associates
Brampton, Ontario, Canada, L6T 0G1
Canada, Quebec
Rhodin Recherche Clinique
Drummondville, Quebec, Canada, J2B 7T1
Recherche Gcp Research
Montreal, Quebec, Canada, H1M 1B1
Medexa Recherche
Victoriaville, Quebec, Canada, G6P 6P6
Canada
Alpha-Recherche Clinique
Quebec, Canada, G3K 2P8
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02097277     History of Changes
Other Study ID Numbers: MB130-002
First Posted: March 27, 2014    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: August 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases