Title
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.
Phase
Phase 3Lead Sponsor
AstraZenecaStudy Type
InterventionalStatus
SuspendedIndication/Condition
Type 2 DiabetesIntervention/Treatment
dapagliflozin ...Study Participants
375This 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.
5mg Oral dose od
10 mg Oral dose od
5/10 mg Oral dose od
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)