Add-on to Thiazolidinedione (TZD) Failures
- Conditions
- Type 2 Diabetes
- Interventions
- Registration Number
- NCT00683878
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on TZD alone. The safety of this treatment will also be studied
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 972
- Males and females, ≥ 18 years old, with type 2 diabetes and with inadequate glycemic control
- All subjects must have central laboratory pre-randomization A1C ≥ 7.0 and ≤ 10.5%
- C-peptide ≥ 1.0 ng/mL (0.34 nmol/L)
- Body Mass Index ≤ 45.0 kg/m²
- AST and /or ALT > 2.5 times the upper limit of normal
- Serum total bilirubin > 2 mg/dL (34.2 µmol/L)
- Creatinine kinase > 3.0 times the upper limit of normal
- Symptoms of severely uncontrolled diabetes
- Serum creatinine ≥ 2.0 mg/dL
- Calculated Cr-Clearance < 50 ml/min (calculated by Cockroft-Gault formula)
- 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 2 Thiazolidinedione (Pioglitazone) - Arm 1 Thiazolidinedione (Pioglitazone) - Arm 3 Thiazolidinedione (Pioglitazone) - Arm 3 Placebo matching Dapagliflozin - Arm 1 Dapagliflozin - Arm 2 Dapagliflozin -
- 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 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 were estimated by modified logistic regression model.
Adjusted Mean Change From Baseline in Total Body Weight (kg) Among 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 among subjects with baseline body mass index (BMI) ≥ 27 kg/m\^2 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, 4, 8, 12, 16, 20, and 24 of 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, 4, 8, 12, 16, 20, and 24 of the double-blind period.
Adjusted Mean Change From Baseline in Waist Circumference (cm) 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 waist circumference 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. Waist circumference measurements were obtained during the qualification and lead-in periods and on Day 1 and Week 24 of the double-blind period.
Adjusted Mean Change From Baseline in 120-minute Post-challenge Plasma Glucose (PPG) (mg/dL) 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. In post oral glucose tolerance test (OGTT), 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. PPG measurements were obtained on Day 1 and week 24 in the double-blind period.
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, 4, 8, 12, 16, 20, and 24 in the double-blind period.
Trial Locations
- Locations (58)
Diabetes Research Center
🇺🇸Tustin, California, United States
Endocrine Research Associates
🇺🇸Jackson, Mississippi, United States
Dallas Diabetes & Endocrine Center
🇺🇸Dallas, Texas, United States
Little Rock Family Practice Clinic
🇺🇸Little Rock, Arkansas, United States
Clinical Research Advantage, Inc
🇺🇸Tempe, Arizona, United States
Advantage Clinical Research
🇺🇸Santa Ana, California, United States
Searcy Medical Center
🇺🇸Searcy, Arkansas, United States
St. Mary'S Center For Diabetes And Endocrinology
🇺🇸Grand Rapids, Michigan, United States
The Center For Nutrition & Preventive Medicine, Pllc
🇺🇸Charlotte, North Carolina, United States
Randall Shue, D.O.
🇺🇸Los Angeles, California, United States
Iicr
🇺🇸Ozark, Alabama, United States
Clinical Innovations, Inc.
🇺🇸Costa Mesa, California, United States
Banksville Medical, Pc
🇺🇸Pittsburgh, Pennsylvania, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
Pinnacle Research Group, Llc
🇺🇸Anniston, Alabama, United States
Northstate Clinical Research
🇺🇸Lenoir, North Carolina, United States
Clinical Research Advantage Inc / Desert Clinical Res, Llc
🇺🇸Tempe, Arizona, United States
Sierra Clinical Research
🇺🇸Roseville, California, United States
Torrance Clinical Research
🇺🇸Lomita, California, United States
Clinical Therapeutics Corporation
🇺🇸Coral Gables, Florida, United States
Olive Branch Family Medical Center
🇺🇸Olive Branch, Mississippi, United States
Danny W. Jackson P.A.
🇺🇸Rolling Fork, Mississippi, United States
Physician Research, Inc.
🇺🇸Zanesville, Ohio, United States
Professional Research Network Of Kansas
🇺🇸Wichita, Kansas, United States
Diabetes Medical Center Of California
🇺🇸Northridge, California, United States
Marin Endocrine Care And Research, Inc.
🇺🇸Greenbrae, California, United States
Suncoast Clinical Res Inc.
🇺🇸New Port Richey, Florida, United States
Health First Clinical Research Group, Inc.
🇺🇸Chipley, Florida, United States
Westside Center For Clinical Research
🇺🇸Jacksonville, Florida, United States
Cedar Crosse Research Center
🇺🇸Chicago, Illinois, United States
Stone Mountain Clinical Research
🇺🇸Stone Mountain, Georgia, United States
Northwest Indiana Center For Clinical Research
🇺🇸Valparaiso, Indiana, United States
Physicians Research Center
🇺🇸Toms River, New Jersey, United States
New Hanover Medical Research
🇺🇸Wilmington, North Carolina, United States
Providence Health Partners - Center For Clinical Research
🇺🇸Dayton, Ohio, United States
Tidewater Integrated Medical Research
🇺🇸Virginia Beach, Virginia, United States
Local Institution
🇨🇳Taipei, Taiwan
43rd Medical Associates, P.C.
🇺🇸Phoenix, Arizona, United States
Ritchken & First M.D.'S
🇺🇸San Diego, California, United States
Aurora Family Medicine Center, P.C.
🇺🇸Aurora, Colorado, United States
Denver Internal Medicine
🇺🇸Denver, Colorado, United States
Baptist Diabetes Associates, Pa
🇺🇸Miami, Florida, United States
Village Family Practice
🇺🇸Houston, Texas, United States
Office Of Dr. Michelle Zaniewski Singh
🇺🇸Houston, Texas, United States
Diabetes & Glandular Disease Research Assoc,, Inc.
🇺🇸San Antonio, Texas, United States
Association Of International Professionals
🇺🇸Las Vegas, Nevada, United States
Central Florida Clinical Trials
🇺🇸Altamonte Springs, Florida, United States
Brookside Family Practice & Pediatrics
🇺🇸Pottstown, Pennsylvania, United States
Finger Lakes Clinical Research
🇺🇸Rochester, New York, United States
Panhandle Family Care Associates
🇺🇸Marianna, Florida, United States
Metrolina Internal Medicine
🇺🇸Charlotte, North Carolina, United States
Family Medical Associates
🇺🇸Levittown, Pennsylvania, United States
William L. Gray, Md
🇺🇸Spokane, Washington, United States
Columbia Clinical Research, Inc.
🇺🇸Columbia, South Carolina, United States
Southeastern Research Associates, Inc.
🇺🇸Taylors, South Carolina, United States
Desert Medical Advances
🇺🇸Palm Desert, California, United States
Avastra Clinical Trials
🇺🇸Redlands, California, United States
Encompass Clinical Research
🇺🇸Spring Valley, California, United States