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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus Type 2

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02097277

MB130-002

Details and patient eligibility

About

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

Enrollment: 219 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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219 participants in 5 patient groups, including a placebo group

Treatment A: Placebo (Matching with BMS-986036 - Daily)

Placebo Comparator group

Description:

Placebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks

Treatment:

Biological: Placebo (Matching with BMS-986036)

Arm 2: Treatment B: BMS-986036 (1 mg Daily)

Experimental group

Description:

BMS-986036 1 mg subcutaneous injection once daily for 12 weeks

Treatment:

Biological: BMS-986036

Treatment C: BMS-986036 (5 mg Daily)

Experimental group

Description:

BMS-986036 5 mg subcutaneous injection once daily for 12 weeks

Treatment:

Biological: BMS-986036

Treatment D: BMS-986036 (20 mg Daily)

Experimental group

Description:

BMS-986036 20 mg subcutaneous injection once daily for 12 weeks

Treatment:

Biological: BMS-986036

Treatment E: BMS-986036 (20 mg Weekly)

Experimental group

Description:

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

Treatment:

Biological: BMS-986036

Biological: Placebo (Matching with BMS-986036)