Evaluate Safety as Mono or Combination Therapies With Anti-diabetes Mellitus Drugs in Japanese Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a long term, single arm, open label study to evaluate the safety and efficacy of dapagliflozin as monotherapy or in combination therapy with other anti diabetic drug in Japanese subjects with type 2 diabetes mellitus who have inadequate blood sugar control on diet and exercise or on other anti-diabetic treatment will be included in this study.

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

Details

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

Criteria

Inclusion Criteria:

• Provision of informed consent prior to any study specific procedures

• Men or women age ≥20 years old (Either gender needs to be 40% or higher of total number of treated subjects)

• diagnosed with type2 DM ; ≥6.5% and ≤10% at 1 week before treatment started

Exclusion Criteria:

• Type 1 diabetes mellitus,

• FPG >240 mg/dL before treatment started

• Subjects who have history of unstable or rapidly progressing renal disease

• Subjects who have severe hepatic insufficiency and/or significant abnormal liver function

• Significant cardiovascular history