Evaluate Efficacy and Safety in Japanese Subjects With Type 2 Diabetes Mellitus

Phase 3

Completed

• Conditions: Type 2 Diabetes; High Blood Sugar
• Interventions: Drug: Dapagliflozin; Drug: Placebo

• Registration Number: NCT01294423
• Lead Sponsor: AstraZeneca

Brief Summary

This is a 24-week randomised, multi-centre phase III study to evaluate the efficacy and safety of dapagliflozin as monotherapy in Japanese subjects with Type 2 diabetes mellitus who have inadequate glycemic control with diet and exercise.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-10
• Study First Submitted QC: 2011-02-10
• Study First Posted: 2011-02-11
• Disposition First Submitted: 2011-05-09
• Disposition First Submitted QC: 2011-05-09
• Disposition First Posted: 2011-05-13
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Results First Submitted: 2013-01-30
• Results First Submitted QC: 2013-07-19
• Results First Posted: 2013-08-23
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-17
• Last Update Posted: 2014-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 261

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 type 2 DM ; ≥6.5% and ≤10% at 1 week before randomization

Exclusion Criteria

• Type 1 diabetes mellitus
• FPG >240 mg/dL before randomization
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Dapagliflozin	Dapagliflozin 5 mg
2	Dapagliflozin	Dapagliflozin 10 mg
3	Placebo	-

Primary Outcome Measures

Name	Time	Method
Adjusted Mean Change in HbA1c Levels	From Baseline to Week 24	To compare change from baseline in HbA1c achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.

Secondary Outcome Measures

Name	Time	Method
Adjusted Mean Change in Fasting Plasma Glucose (FPG)	From Baseline to Week 24	To compare the change from baseline in fasting plasma glucose (FPG) achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.
Adjusted Mean Change in Body Weight	From Baseline to Week 24	To compare the change from baseline in total body weight achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.

Trial Locations

Locations (1)

Research Site; 🇯🇵 Tokyo, Japan