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

Study Overview
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Brief Summary
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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.

Official Title
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A 24-week Randomised, Double-blind, Parallel-group, Multi-centre, Placebo-controlled Phase III Trial to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Japanese Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

Conditions
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Type 2 Diabetes, High Blood Sugar

Intervention / Treatment
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* Drug: Dapagliflozin
* Drug: Dapagliflozin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dapagliflozin 5 mg | Drug: Dapagliflozin<br>* Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose<br>|
| Experimental: 2<br>Dapagliflozin 10 mg | Drug: Dapagliflozin<br>* Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose<br>|
| Placebo Comparator: 3<br> | Drug: Placebo<br>* Matching placebo for Dapagliflozin 5mg/10mg oral dose<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase3, Clinical trial, Type2 Diabetes Mellitus