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

A 24-week,Multi-centre,Int.,Double-blind,Rand.,Parallel-group,Plac.-Controlled,Phase III Study With a 78-week Ext.Per. to Evaluate the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone

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.

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