Evaluation of the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type 2 Diabetes

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is being carried out to see if dapagliflozin in addition to metformin decreases body weight and if so, how it compares with metformin alone.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Bristol-Myers Squibb
• Treatments: Dapagliflozin; Metformin; Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• Type 2 diabetes

• Ongoing treatment with metformin on a stable dose of ≥1500 mg/day for at least 12 weeks prior to enrolment

• Inadequate glycemic control, defined as HbA1c ≥6.5% and ≤8.5%

• ≥30 years for males

• ≥55 years for females

Exclusion Criteria:

• Type 1 Diabetes

• Body weight change >5% within 3 months prior to enrolment

• Renal and liver impairment