Status:
COMPLETED
A Trial of BMS-512148 in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-79 years
Phase:
PHASE2
Brief Summary
The purpose of this clinical research study is to learn if BMS-512148 is effective in controlling blood sugar levels as determined by HbA1c and fasting plasma glucose in patients who have been diagnos...
Eligibility Criteria
Inclusion
- Patients with Type 2 diabetes mellitus with inadequate glycemic control on diet and exercise. HbA1c \>= 7% and \<=10%.
- Patient either has not been previously treated with antihyperglycemic medication or has been treated for \<30 days since diagnosis and has received less than 3 consecutive doses or 7 non-consecutive doses in the last 30 days.
- C-peptide \> 1.0 ng/ml
- Body Mass Index \<= 40 kg/m2
- Serum creatinine \< 1.5 mg/dL for men or \< 1.4 mg/dL for women.
- No overt proteinuria (microalbumin/creatinine ratio must be \<300 mg/g
Exclusion
- Unstable renal disease
- Patients with significant liver disease including chronic active hepatitis
- Within the last 6 months has had any of the following cardiovascular event: myocardial infarction, unstable angina, unstable CHF,NYHA Class III or IV CHF, TIA, unstable arrhythmia or cardiac revascularization surgery.
- Subjects with clinically significant anemia
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
389 Patients enrolled
Trial Details
Trial ID
NCT00263276
Start Date
December 1 2005
End Date
February 1 2007
Last Update
November 17 2016
Active Locations (144)
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Local Institution
Bayou La Batre, Alabama, United States
2
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Birmingham, Alabama, United States
3
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Huntsville, Alabama, United States
4
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Mobile, Alabama, United States