An Efficacy & Safety Study of BMS-512148 in Combination With Metformin Extended Release Tablets
- Registration Number
- NCT00643851
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this clinical research study is to learn if initiating treatment with BMS-51248 (Dapagliflozin) in combination with metformin XR can improve diabetes control in patients with Type 2 Diabetes who do not receive any pharmacological treatment for diabetes, when compared to initial treatment with monotherapy dapagliflozin or metformin XR. The safety of this treatment will also be studied
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 994
- Males & females, 18-77 years old inclusive, with type 2 diabetes and with inadequate glycemic control
- Drug naive or treated with anti-diabetic medication for < 24 weeks since original diagnosis
- C-peptide ≥ 1.0 ng/mL
- Body Mass Index ≤ 45.0 kg/m
- Serum creatinine < 1.50 mg/dL for men or < 1.40 mg/dL for women
- AST and/or ALT >3.0 times the upper limit of normal (ULN)
- Serum total bilirubin > 2.0 mg/dL
- Creatine kinase > 3X the upper limit of normal (ULN)
- Symptoms of severely uncontrolled diabetes
- Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric or rheumatic diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Dapagliflozin Dapagliflozin (5 mg) + Metformin XR (up to 2000 mg) Arm 1 Metformin XR Dapagliflozin (5 mg) + Metformin XR (up to 2000 mg) Arm 2 Dapagliflozin Dapagliflozin (5 mg) Arm 3 Metformin XR Metformin XR (500 mg up to 2000 mg)
- Primary Outcome Measures
Name Time Method Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]) From Baseline to Week 24 HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double- blind period.
- Secondary Outcome Measures
Name Time Method Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF]) From Baseline to Week 24 Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 in the double-blind period.
Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF]) From Baseline to Week 24 Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c \<7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Mean and standard error for percentage of participants estimated by modified logistic regression model.
Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) in Subjects With Baseline HbA1c ≥ 9% at Week 24 (Last Observation Carried Forward [LOCF]) From Baseline to Week 24 HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.
Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF]) From Baseline to Week 24 Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.
Adjusted Mean Change From Baseline in Total Body Weight (kg) in Subjects With Baseline Body Mass Index (BMI) ≥ 27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF]) From Baseline to Week 24 Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.
Trial Locations
- Locations (45)
Southeastern Research Associates, Inc.
🇺🇸Greenville, South Carolina, United States
Jackson Clinic
🇺🇸Rolling Fork, Mississippi, United States
Community Health Care, Inc.
🇺🇸Canal Fulton, Ohio, United States
Integris Family Care Yukon
🇺🇸Yukon, Oklahoma, United States
Deerbrook Medical Associates
🇺🇸Vernon Hills, Illinois, United States
Willamette Valley Clinical Studies
🇺🇸Eugene, Oregon, United States
Gilbert Medical Research, Llc
🇺🇸Bethany, Oklahoma, United States
Metrolina Medical Research
🇺🇸Charlotte, North Carolina, United States
Hudson Valley Clinical Research Center
🇺🇸Kingston, New York, United States
Southwest Clinical Research Center, Llc
🇺🇸Pearland, Texas, United States
Physician Research, Inc.
🇺🇸Zanesville, Ohio, United States
Inst. Of Clin. Research At The Diabetes Cntr. Of The Sw
🇺🇸Midland, Texas, United States
Hill Country Medical Associates
🇺🇸New Braunfels, Texas, United States
Valley Research
🇺🇸Fresno, California, United States
Fpa Clinical Research
🇺🇸Kissimmee, Florida, United States
Cedar Crosse Research Center
🇺🇸Chicago, Illinois, United States
Mercy Medical Group/Dba Woodlake Research
🇺🇸Chesterfield, Missouri, United States
Spartanburg Medical Research
🇺🇸Spartanburg, South Carolina, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
Endocrine Associates
🇺🇸Houston, Texas, United States
Village Family Practice
🇺🇸Houston, Texas, United States
Non-Invasive Cardiovascular, Pa
🇺🇸Houston, Texas, United States
Texas Center For Drug Development
🇺🇸Houston, Texas, United States
Wells Institute For Health Awareness
🇺🇸Kettering, Ohio, United States
Newark Physician Associates
🇺🇸Newark, Ohio, United States
Southland Clinical Research Center, Inc.
🇺🇸Fountain Valley, California, United States
Nextphase Clinical Trials, Inc.
🇺🇸Miami, Florida, United States
Covenant Clinical Research, Pa
🇺🇸San Antonio, Texas, United States
S.A.M. Clinical Research Center
🇺🇸San Antonio, Texas, United States
Integris Family Care South Penn
🇺🇸Oklahoma City, Oklahoma, United States
Local Institution
🇺🇦Zhytomyr, Ukraine
Greystone Medical Research, Llc
🇺🇸Birmingham, Alabama, United States
Clinical Research Advantage, Inc.
🇺🇸Tempe, Arizona, United States
John Muir Physician Network Clinical Research Center
🇺🇸Concord, California, United States
Clinical Therapeutics Corporation
🇺🇸Coral Gables, Florida, United States
Winston Technology Research, Llc
🇺🇸Haleyville, Alabama, United States
Middle Georgia Drug Study Center, Llc
🇺🇸Perry, Georgia, United States
Biomedical Research Associates, Llc
🇺🇸Shippensburg, Pennsylvania, United States
Commonwealth Primary Care, Pc / Fleetwood Clinical Research
🇺🇸Fleetwood, Pennsylvania, United States
Safe Harbor Clinical Research
🇺🇸East Providence, Rhode Island, United States
Middle Tennessee Clinical Research
🇺🇸Fayetteville, Tennessee, United States
Excel Clinical Research, Llc
🇺🇸Houston, Texas, United States
Crescent Medical Research
🇺🇸Salisbury, North Carolina, United States
Florida Research Network, Llc
🇺🇸Gainesville, Florida, United States
Central Florida Clinical Trials, Inc.
🇺🇸Altamonte Springs, Florida, United States