Trial to Evaluate the Efficacy and Safety of Dapagliflozin in Japanese Type 2 Diabetes Mellitus Patients

Study Overview
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Brief Summary
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The purpose of this study is to obtain information on efficacy and safety of dapagliflozin in Japanese patients with Type 2 Diabetes. This will be done by comparing the effect of dapagliflozin to placebo when given in oral doses.

Official Title
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A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Trial to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Japanese Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Dapagliflozin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Japanese Subjects with type 2 diabetes mellitus. Strictly/relatively treatment naïve Subjects with HbA1c ≥ 7.0% and ≤ 10%, or Subjects treated with single or two (less than half of the approved maximal dose for each) oral anti-hyperglycaemic agent with HbA1c ≤ 8%. Provision of informed consent. Exclusion Criteria: Having clinically relevant medical history or concurrent disease such as cardiovascular disease, renal disease, retinopathy, hepatic disease and haematological disease. The investigator(s) judged that the Subject should not participate in the study according to screening test or medical history.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>1mg dapagliflozin | Drug: Dapagliflozin<br>* once daily, 12 weeks<br>|
| Experimental: 2<br>2.5mg dapagliflozin | Drug: Dapagliflozin<br>* once daily, 12 weeks<br>|
| Experimental: 3<br>5mg dapagliflozin | Drug: Dapagliflozin<br>* once daily, 12 weeks<br>|
| Experimental: 4<br>10mg dapagliflozin | Drug: Dapagliflozin<br>* once daily, 12 weeks<br>|
| Placebo Comparator: 5<br>Placebo | Drug: Placebo<br>* once daily, 12 weeks<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 | The primary efficacy endpoint is the absolute change in HbA1c from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available. | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted Mean Change in Fasting Plasma Glucose | Change in fasting plasma glucose from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available. | Baseline to Week 12 | 
| Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7% | Proportion of participants achieving therapeutic glycemic response defined as glycosylated hemoglobin <7%, after 12 weeks of double-blind therapy | At Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes mellitus, Japanese, phase 2, efficacy, safety, dapagliflozin