Type 2 Diabetes Mellitus | Phase 4: Investigational Study to Evaluate Metformin XR Monotherapy Versus Metformin IR Monotherapy in Subjects With Type 2 Diabetes
Type 2 Diabetes Mellitus research study
What is the primary objective of this study?
The purpose of this study is determine if Metformin XR monotherapy in subjects with type 2 diabetes is non-inferior to Metformin IR monotherapy
Who is eligible to participate?
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)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Type 2 Diabetes Mellitus
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Placebo matching with Metformin XR
Drug:Placebo matching with Metformin IR
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Arm 1: Metformin XR and Placebo matching with Metformin XRMetformin 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
Arm 2: Metformin IR and Placebo matching with Metformin IRMetformin 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
Start Date: June 20, 2013
Completed Date: June 1, 2016
Phase: Phase 4
Primary Outcome: Adjusted Mean Change From Baseline in HbA1c
Secondary Outcome: Mean Change in Fasting Plasma Glucose (FPG)
Study sponsors, principal investigator, and references
Principal Investigator: Bristol-Myers Squibb
Lead Sponsor: Bristol-Myers Squibb