Status:
COMPLETED
Study of Multiple Doses of Saxagliptin (BMS-477118)
Lead Sponsor:
AstraZeneca
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
21-70 years
Phase:
PHASE2
Brief Summary
To evaluate the positive efficacy trend among doses of saxagliptin (BMS-477118) in subjects with Type 2 diabetes mellitus by assessing the change from baseline in HbA1c following 12 weeks of double-bl...
Eligibility Criteria
Inclusion
- Type 2 diabetes who are drug-naive
- Screening HbA1c ≥ 6.8% and ≤ 9.7%
- Screening fasting or random C-peptide \> 0.5 ng/mL
- \< 35 years old must be negative for anti-GAD antibodies
- Body Mass Index \< 35 kg/m2
Exclusion
- Symptoms of poorly controlled diabetes
- History of diabetic ketoacidosis, hyperosmolar nonketotic coma, or insulin therapy within one year of screening
- Receipt of oral antihyperglycemic medications for more than six months in total since diagnosis
- Significant cardiovascular history
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2004
Estimated Enrollment :
423 Patients enrolled
Trial Details
Trial ID
NCT00950599
Start Date
May 1 2003
End Date
May 1 2004
Last Update
April 3 2015
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