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

Sponsor
AstraZeneca
Study ID
NCT01294436
Phase
PHASE3
Status
Completed

Conditions

  • High Blood Sugar
  • Type2 Diabetes

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Feb 28, 2011
Status verified
Nov 2013
Primary completion
Sep 30, 2012
Completion
Sep 30, 2012

Study Design

Enrollment
728 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Open label treatment

Primary Outcome Measure

Proportion of Participants With Adverse Events [ Time Frame: Long-term treatment up to 52 weeks ]

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