Phase 4: Investigational Study to Evaluate Metformin XR Monotherapy Versus Metformin IR Monotherapy in Subjects With Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT01864174|
Recruitment Status : Completed
First Posted : May 29, 2013
Results First Posted : July 21, 2017
Last Update Posted : November 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1736 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Study Start Date :||June 20, 2013|
|Actual Primary Completion Date :||June 1, 2016|
|Actual Study Completion Date :||June 1, 2016|
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 XR
Drug: 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: Glucophage
Drug: Placebo matching with Metformin IR
- Adjusted Mean Change From Baseline in HbA1c [ Time Frame: Baseline and 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: Baseline and 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: Baseline and 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.
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): NCT01864174
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|