A Pilot Study of BMS-512148 in Subjects With Type 2 Diabetes
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes
Intervention: Dapagliflozin (Drug); Placebo (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb
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.
Clinical Details
Official title: A Pilot Study of the Efficacy and Safety of BMS-512148 on Glycemic Control in Subjects With Type 2 Diabetes Treated Aggressively But Not Controlled on Combination Antihyperglycemic Therapy With Metformin and/or Thiazolidinedione (TZD) and Insulin.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change from baseline in hemoglobin A1C
Secondary outcome: Change from baseline in fasting plasma glucoseChange from baseline in the proportion of subjects achieving therapeutic glycemic responses Change from baseline in the total daily dose of insulin
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Locations and Contacts
Nea Clinic, Jonesboro, Arkansas 72401, United States
Valley Research, Fresno, California 93720, United States
Bernstein, Richard, Greenbrae, California 94904, United States
Jacksonville Center For Clinical Research, Jacksonville, Florida 32205, United States
Endocrine Research Solutions, Inc., Roswell, Georgia 30076, United States
Indiana University, Indianapolis, Indiana 46202, United States
Local Institution, Winnipeg, Manitoba R3E 3P4, Canada
Model Clinical Research Llc, Baltimore, Maryland 21204, United States
University Of Michigan, Ann Arbor, Michigan 48109, United States
St. Louis Center For Clinical Research, St. Louis, Missouri 63128, United States
Local Institution, Bathurst, New Brunswick E2A 4X7, Canada
Suny Upstate Medical University, Syracuse, New York 13210, United States
Mountain Diabetes And Endocrine Center, Asheville, North Carolina 28801, United States
Your Diabetes Endocrine Nutrition Group, Mentor, Ohio 44060, United States
Local Institution, Gatineau, Quebec J8V 2P5, Canada
Local Institution, Laval, Quebec H7T 2P5, Canada
Local Institution, Longueuil, Quebec J4N 1L6, Canada
Local Institution, Pointe-Claire, Quebec H9R 4S3, Canada
Local Institution, Sherbrooke, Quebec J1G 5K2, Canada
Research Institute Of Dallas, P.A., Dallas, Texas 75231, United States
Diabetes And Glandular Disease Research Associates, P.A., San Antonio, Texas 78229, United States
Rainier Clinical Research Center, Renton, Washington 98055, United States
Advanced Healthcare S.C., Milwaukee, Wisconsin 53209, United States
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
Starting date: October 2006
Last updated: March 20, 2015
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