Phase 4: Investigational Study to Evaluate Metformin XR Monotherapy Versus Metformin IR Monotherapy in Subjects With Type 2 Diabetes
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: Metformin XRDrug: Metformin IRDrug: Placebo matching with Metformin XRDrug: Placebo matching with Metformin IR
- Registration Number
- NCT01864174
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is determine if Metformin XR monotherapy in subjects with type 2 diabetes is non-inferior to Metformin IR monotherapy
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1736
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1: Metformin XR and Placebo matching with Metformin XR 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 Arm 1: Metformin XR and Placebo matching with Metformin XR 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 Arm 2: Metformin IR and Placebo matching with Metformin IR 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 Arm 2: Metformin IR and Placebo matching with Metformin IR 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
- Primary Outcome Measures
Name Time Method Adjusted Mean Change From Baseline in HbA1c 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 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.
- Secondary Outcome Measures
Name Time Method Mean Change in Fasting Plasma Glucose (FPG) 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
Percent of Participants With HbA1c < 7% Week 24 Percent of participants achieving a therapeutic glycemic response (defined as HbA1c \< 7.0%) at Week 24 in the double-blind treatment period.
Mean Change in Mean Daily Glucose (MDG) 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.
Trial Locations
- Locations (47)
Policlinica Dr. Luis Rodriguez
🇵🇷Carolina, Puerto Rico
Center For Clinical Trials Of Sacramento, Inc.
🇺🇸Sacramento, California, United States
Cedar-Crosse Research Ctr
🇺🇸Chicago, Illinois, United States
Medical Research Unlimited, Inc.
🇺🇸Cincinnati, Ohio, United States
Covenant Clinical Research, Pa
🇺🇸San Antonio, Texas, United States
Central Alabama Research
🇺🇸Birmingham, Alabama, United States
Clinical Res Advantage Central
🇺🇸Phoenix, Arkansas, United States
Terence T. Hart, Md
🇺🇸Muscle Shoals, Alabama, United States
Actca
🇺🇸Los Angeles, California, United States
Marin Endocrine Care And Research, Inc.
🇺🇸Greenbrae, California, United States
National Research Institute
🇺🇸Los Angeles, California, United States
R. Srinivasan, M.D., Inc.
🇺🇸Monterey Park, California, United States
Clinical Research Advantage
🇺🇸Colorado Springs, Colorado, United States
Solutions Through Advanced Research, Inc.
🇺🇸Jacksonville, Florida, United States
Clinical Research Advantage, Inc/Co Springs Health Partners, Briar
🇺🇸Colorado Springs, Colorado, United States
Family Care Partners
🇺🇸Jacksonville, Florida, United States
Omega Research Consultants, Llc
🇺🇸Orlando, Florida, United States
Palm Harbor Medical Associates
🇺🇸Palm Harbor, Florida, United States
Gulfcoast Medical Research Center, Llc
🇺🇸Tampa, Florida, United States
American Health Network Of In Llc
🇺🇸Muncie, Indiana, United States
Columbia Medical Practice
🇺🇸Columbia, Maryland, United States
Centennial Medical Group
🇺🇸Elkridge, Maryland, United States
Ny Clinical Trials
🇺🇸New York, New York, United States
Drs. Rodbard And Dempsey
🇺🇸Rockville, Maryland, United States
White Oak Family Physicians, Pa
🇺🇸Asheboro, North Carolina, United States
Metrolina Internal Medicine
🇺🇸Charlotte, North Carolina, United States
Lion Research
🇺🇸Norman, Oklahoma, United States
Lynn Institute of Norman
🇺🇸Norman, Oklahoma, United States
Palmetto Clinical Trial Services Llc
🇺🇸Fountain Inn, South Carolina, United States
Dallas Diabetes & Endocrine Center
🇺🇸Dallas, Texas, United States
Local Institution
🇬🇧Nuneaton, United Kingdom
Holston Medical Group
🇺🇸Bristol, Tennessee, United States
Independence Family Medicine
🇺🇸Virginia Beach, Virginia, United States
Fb Med Research, Psc
🇵🇷Caguas, Puerto Rico
Luis Rivera-Colon, Md
🇵🇷Las Lomas, Puerto Rico
Ponce School Of Medicine
🇵🇷Ponce, Puerto Rico
Research & Cardiovascular Corp
🇵🇷Ponce, Puerto Rico
The Office Of Miguel Sosa-Padilla, Md
🇵🇷San Juan, Puerto Rico
Caparra Internal Med Res Ctr
🇵🇷Rio Grande, Puerto Rico
Altamira Family Medicine And Research Institute
🇵🇷San Juan, Puerto Rico
Colorado Springs Family Practice
🇺🇸Colorado Springs, Colorado, United States
Clini Res Advantage Desert Clin Res, Llc
🇺🇸Mesa, Arizona, United States
Torrance Clinical Research Institute Inc.
🇺🇸Lomita, California, United States
Diabetes Medical Center Of California
🇺🇸Northridge, California, United States
Valley Clinical Trials
🇺🇸Northridge, California, United States
Clinical Research Advantage, Inc./Family Medicine Associates
🇺🇸Evansville, Indiana, United States
Integrated Medical Group Pc / Fleetwood Medical Assoc.
🇺🇸Fleetwood, Pennsylvania, United States