A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone
- Conditions
- Type 2 Diabetes
- Interventions
- Registration Number
- NCT00528879
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this clinical research study is to learn whether dapagliflozin can help reduce blood sugar levels in participants with Type 2 diabetes that is not well controlled on metformin alone. The safety of this treatment will also be studied.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 915
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo + Metformin Metformin Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks Dapagliflozin, 2.5 mg + Metformin Dapagliflozin Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks Dapagliflozin, 2.5 mg + Metformin Metformin Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks Placebo + Metformin Placebo Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks Dapagliflozin, 10 mg + Metformin Placebo Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks Dapagliflozin, 5 mg + Metformin Dapagliflozin Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks Dapagliflozin, 10 mg + Metformin Dapagliflozin Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks Dapagliflozin, 5 mg + Metformin Metformin Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks Dapagliflozin, 10 mg + Metformin Metformin Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
- 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 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. Data after rescue medication was excluded from this analysis. 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.
Adjusted Mean Change From Baseline in Total Body Weight 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.
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.
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline HbA1c ≥9.0% 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. HbA1c was measured as percent of hemoglobin by a central laboratory. The population included those randomized participants who received treatment and had a baseline HbA1c \> 9.0%. Data after rescue medication were 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.
Adjusted Mean Change From Baseline in Total Body Weight at Week 24 in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (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 Hemoglobin A1c (HbA1c) in Participants 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 for baseline HbA1c. HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication were 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.
Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 1 (Last Observation Carried Forward [LOCF]) From Baseline to Week 1 Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured 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.
Adjusted Percentage of Participants Achieving Hemoglobin A1c (HbA1C) ≤6.5% 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. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.
Trial Locations
- Locations (29)
Clinical Research Advantage / Desert Clinical Res, Llc
🇺🇸Tempe, Arizona, United States
Raikhel, Marina
🇺🇸Torrance, California, United States
Office Of Dr. Gray
🇺🇸Spokane, Washington, United States
Randall Shue, D.O.
🇺🇸Los Angeles, California, United States
Woodlake Research
🇺🇸Chesterfield, Missouri, United States
Central Florida Clinical Trials, Inc.
🇺🇸Altamonte Springs, Florida, United States
Southeastern Research Assoc
🇺🇸Taylors, South Carolina, United States
Express Care Clinical Res
🇺🇸Colorado Springs, Colorado, United States
Local Institution
🇲🇽Durango, Mexico
Cumberland Valley Endocrinology Center, Llc
🇺🇸Carlisle, Pennsylvania, United States
Ritchken & First M.D.'S
🇺🇸San Diego, California, United States
Nevada Alliance Against Diabetes
🇺🇸Las Vegas, Nevada, United States
Texas Center For Drug Development, P.A.
🇺🇸Houston, Texas, United States
Diabetes & Glandular Disease Research Associates, Inc.
🇺🇸San Antonio, Texas, United States
Health Partners Research Foundation
🇺🇸Minneapolis, Minnesota, United States
Medical Group Of Encino
🇺🇸Encino, California, United States
Diabetes Medical Center Of California
🇺🇸Northridge, California, United States
New West Physicians
🇺🇸Golden, Colorado, United States
Denver Internal Medicine
🇺🇸Denver, Colorado, United States
Family Care Associates Of Nw Florida
🇺🇸Chipley, Florida, United States
Diabetes & Endocrinology Consultants, Pc
🇺🇸Morehead City, North Carolina, United States
Newark Physician Associates
🇺🇸Newark, Ohio, United States
Banksville Medical Pc
🇺🇸Pittsburgh, Pennsylvania, United States
Integris Family Care S. Penn
🇺🇸Oklahoma City, Oklahoma, United States
S.A.M. Clinical Research Center
🇺🇸San Antonio, Texas, United States
Optimum Clinical Research
🇺🇸Salt Lake City, Utah, United States
Encompass Clinical Research
🇺🇸Spring Valley, California, United States
Valley Research
🇺🇸Fresno, California, United States
Palmetto Clinical Research
🇺🇸Summerville, South Carolina, United States