Evaluation of Efficacy and Safety of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Diet and Exercise Alone

A 24-week National Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase III Trial in India to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Diet and Exercise Alone.

This study intends to compare the efficacy and safety of dapagliflozin versus placebo in treatment-naïve subjects with type 2 diabetes who have inadequate glycaemic control with diet and exercise alone.

Inclusion Criteria:

• Provision of informed consent before participating in the study
• Diagnosed with type 2 diabetes (high blood sugar); HbA1c ≥ 7.2% and ≤10.0%
• Subjects should be drug naïve
• Women of childbearing potential who comply to use an adequate method of contraception to avoid pregnancy throughout the study & who have a negative serum or urine pregnancy test

Exclusion Criteria:

• Subjects received Insulin therapy within one year of enrollment
• Subjects who have severe uncontrolled hypertension
• Subjects who have history of unstable or rapidly progressing renal disease
• Subjects who have severe liver disease
• Subjects who receiving treatment for Human immunodeficiency virus (HIV)