Study of Multiple Doses of Saxagliptin (BMS-477118)

• Status: Completed
• Trial end date: 2004-05-01
• Target enrollment: 0
• Participant gender: All

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-blind treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Saxagliptin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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