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 3
  • Study Type

    Interventional
  • Status

    Suspended
  • Intervention/Treatment

    dapagliflozin ...
  • Study Participants

    375
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.
Study Started
Jan 31
2012
Primary Completion
Jun 30
2013
Anticipated
Study Completion
Jun 30
2013
Anticipated
Last Update
Mar 01
2012
Estimate

Drug Dapagliflozin

5mg Oral dose od

Drug Dapagliflozin

10 mg Oral dose od

Drug placebo

5/10 mg Oral dose od

3 Placebo Comparator

1 Experimental

2 Experimental

Criteria

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)
No Results Posted