Status:
COMPLETED
A Pilot Study of BMS-512148 in Subjects With Type 2 Diabetes
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
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 b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT00357370
Start Date
October 1 2006
End Date
March 1 2008
Last Update
May 11 2017
Active Locations (23)
Enter a location and click search to find clinical trials sorted by distance.
1
Nea Clinic
Jonesboro, Arkansas, United States, 72401
2
Valley Research
Fresno, California, United States, 93720
3
Bernstein, Richard
Greenbrae, California, United States, 94904
4
Jacksonville Center For Clinical Research
Jacksonville, Florida, United States, 32205