Phase 4: Investigational Study to Evaluate Metformin XR Monotherapy Versus Metformin IR Monotherapy in Subjects With Type 2 Diabetes

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo matching with Metformin XR; Drug: Metformin XR; Drug: Placebo matching with Metformin IR; Drug: Metformin IR

Study type: Interventional

Funder types: Industry

Identifiers

NCT01864174

CV181-206

2012-004531-23 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is determine if Metformin XR monotherapy in subjects with type 2 diabetes is non-inferior to Metformin IR monotherapy

Enrollment: 1,736 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Men and women, aged ≥18 years old at time of enrollment
• Treatment naive subjects with type 2 diabetes mellitus with inadequate glycemic (HbA1c ≥7.0% and ≤9.2% obtained at screening visit) control on diet and exercise alone
• Women must have a negative serum or urine test within 24 hours prior to start of investigational product

Exclusion Criteria:

• History of ketoacidosis, lactic acidosis or hyperosmolar non-ketonic coma
• Symptoms of poorly controlled diabetes, including but not limited to marked polyuria and polydipsia with >10% weight loss during last 3 months
• Serum creatinine ≥1.50 mg/dL (133 μmol/L) for male subjects; serum creatinine ≥1.40 mg/dL (124 μmol/L for female subjects)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,736 participants in 2 patient groups

Arm 1: Metformin XR and Placebo matching with Metformin XR

Active Comparator group

Description:

Metformin Extended Release (XR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks Placebo matching with Metformin XR 0 mg tablets by mouth twice daily (BID) for 24 weeks

Treatment:

Drug: Placebo matching with Metformin XR

Drug: Metformin XR

Arm 2: Metformin IR and Placebo matching with Metformin IR

Active Comparator group

Description:

Metformin Immediate Release (IR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks Placebo matching with Metformin IR 0 mg tablets by mouth twice daily (BID) for 24 weeks

Treatment:

Drug: Metformin IR

Drug: Placebo matching with Metformin IR