A Pilot Study of BMS-512148 in Subjects With Type 2 Diabetes
- Registration Number
- NCT00357370
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this clinical research study is to learn if BMS-512148, added to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone), can help reduce the blood sugar levels compared to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone) alone, in subjects with type 2 diabetes. The safety of this treatment will also be studied.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 163
- Males and females, 18 to 75 years old, with type 2 diabetes with inadequate glycemic control
- Subjects receiving insulin and metformin and/or a thiazolidinedione
- Body Mass Index <=45.0 kg/m2
- Serum creatinine <1.5 mg/dL for men or <1.4 mg/dL for women
- No overt proteinuria (in subjects with a microalbumin/creatinine ratio ≥300 mg/g, the 24-hour urinary excretion of total protein must be <3 g/24 hrs)
- History of type 1 diabetes
- AST and/or ALT >2.5 times the upper limit of normal
- Creatinine kinase ≥3 times the upper limit of normal
- Symptoms of severely uncontrolled diabetes
- History of hypoglycemic unawareness
- 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 Cohort 1 Dapagliflozin 20 mg Cohort 2 - Arm 1 Dapagliflozin 10 mg Cohort 2 - Arm 2 Dapagliflozin 20 mg Cohort 2 - Arm 3 Placebo -
- Primary Outcome Measures
Name Time Method Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2 From Baseline to Week 12 HbA1c was measured as percent of hemoglobin by a central laboratory. Data after insulin uptitration 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, 6, 8, 10, and 12 in the double-blind period.
- Secondary Outcome Measures
Name Time Method Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2 From Baseline to Week 12 Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Data after insulin uptitration 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. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 6, 8, 10, and 12 in the double-blind period.
Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2 From Baseline to Week 12 Therapeutic glycemic response is defined as HbA1c \<7.0%. Data after insulin uptitration was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.
Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <=6.5% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2 From Baseline to Week 12 Therapeutic glycemic response is defined as HbA1c \<=6.5%. Data after insulin uptitration was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.
Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) Decrease From Baseline >= 0.5% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2 From Baseline to Week 12 Therapeutic glycemic response is defined as HbA1c decrease from baseline \>= 0.5% at Week 12. Data after insulin uptitration was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.
Adjusted Mean Total Daily Dose of Insulin (TDDI) Change From Baseline at Week 12 (LOCF), Including Data After Up-titration of Insulin) - Cohort 2 From Baseline to Week 12 Baseline TDDI was reduced by 50% prior to treatment, except 2 subjects. TDDI could be up-titrated according to prespecified criteria at Weeks 4, 6, 8, 10 and 12 in the double-blind period.
Trial Locations
- Locations (17)
Nea Clinic
🇺🇸Jonesboro, Arkansas, United States
Mountain Diabetes And Endocrine Center
🇺🇸Asheville, North Carolina, United States
Research Institute Of Dallas, P.A.
🇺🇸Dallas, Texas, United States
Model Clinical Research Llc
🇺🇸Baltimore, Maryland, United States
Suny Upstate Medical University
🇺🇸Syracuse, New York, United States
Local Institution
🇨🇦Sherbrooke, Quebec, Canada
Your Diabetes Endocrine Nutrition Group
🇺🇸Mentor, Ohio, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Diabetes And Glandular Disease Research Associates, P.A.
🇺🇸San Antonio, Texas, United States
Advanced Healthcare S.C.
🇺🇸Milwaukee, Wisconsin, United States
Valley Research
🇺🇸Fresno, California, United States
Jacksonville Center For Clinical Research
🇺🇸Jacksonville, Florida, United States
Bernstein, Richard
🇺🇸Greenbrae, California, United States
Rainier Clinical Research Center
🇺🇸Renton, Washington, United States
St. Louis Center For Clinical Research
🇺🇸St. Louis, Missouri, United States
Endocrine Research Solutions, Inc.
🇺🇸Roswell, Georgia, United States
University Of Michigan
🇺🇸Ann Arbor, Michigan, United States