Phase 4: Investigational Study to Evaluate Metformin XR Monotherapy Versus Metformin IR Monotherapy in Subjects With Type 2 Diabetes
|Type 2 Diabetes Mellitus||Drug: Metformin XR Drug: Metformin IR Drug: Placebo matching with Metformin XR Drug: Placebo matching with Metformin IR||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
|Official Title:||A 24-Week International, Multi-center, Randomized, Parallel-group, Double-blind Trial to Evaluate Metformin Extended Release Monotherapy Compared to Metformin Immediate Release Monotherapy in Adults Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise|
- Adjusted Mean Change From Baseline in HbA1c [ Time Frame: Baseline to Week 24 ]Mean change in glycated hemoglobin (HbA1c) from baseline to Week 24 in the double-blind treatment period.
- Number of Participants With Death, Serious Adverse Events (SAEs), SAEs Related to Study Therapy, SAEs Leading to Discontinuation, Adverse Events (AEs) Related to Study Therapy, and AEs Leading to Discontinuation [ Time Frame: Date of first dose (Day 1) up to 30 post last dose of study drug (approx. 28 weeks) ]SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug. All listed events are treatment emergent, which is defined as nonserious and serious AEs with an onset from Day 1 of the double-blind treatment up to and including 4 days and 30 days respectively, after the last dose date of double-blind study. randomized.
- Mean Change in Fasting Plasma Glucose (FPG) [ Time Frame: Week 24 ]The mean change in fasting plasma glucose (FPG) from baseline to Week 24 in the double-blind treatment period was assessed. The lack of glycemic control criteria for initiation of rescue medication during Week 12 to Week 24 was having a FPG > 200 mg/dL (11.1 mmol/L). mg/dL = milligrams per deciliter; mmol/L = millimole per Liter
- Mean Change in Mean Daily Glucose (MDG) [ Time Frame: Week 24 ]The mean change in Mean Daily Glucose (MDG) from baseline to Week 24 in the double-blind treatment period was assessed. Prior to the Day 1 visit (between Week -1 and Day 1) and in the week before the Week 24/Study Termination and Rescue or Early Treatment Termination visit, participants performed 7-point finger stick blood glucose monitoring (before and 2 hours after 3 meals per day, and at bedtime) for 3 consecutive days in order to determine their MDG.
- Percent of Participants With HbA1c < 7% [ Time Frame: Week 24 ]Percent of participants achieving a therapeutic glycemic response (defined as HbA1c < 7.0%) at Week 24 in the double-blind treatment period.
|Actual Study Start Date:||June 20, 2013|
|Study Completion Date:||June 1, 2016|
|Primary Completion Date:||June 1, 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Arm 1: Metformin XR and Placebo matching with Metformin XR
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
Drug: Metformin XR
Other Name: Glucophage XRDrug: Placebo matching with Metformin XR
Active Comparator: Arm 2: Metformin IR and Placebo matching with Metformin IR
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
Drug: Metformin IR
Other Name: GlucophageDrug: Placebo matching with Metformin IR
Please refer to this study by its ClinicalTrials.gov identifier: NCT01864174
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|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|