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

• Status: Suspended
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Bristol-Myers Squibb
• Treatments: Dapagliflozin

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)