Efficacy and Safety Study of TA-7284 in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of TA-7284 as monotherapy in patients with type 2 Diabetes for 24 weeks administration.

Detailed Description
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This is a randomized, 3-arm, parallel group, double blind study to evaluate the efficacy and safety of TA-7284 in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise. The patients will receive either TA-7284-Low, TA-7284-High or Placebo orally alone for 24 weeks.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of TA-7284 as Monotherapy in the Treatment of Subjects With Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: TA-7284 Low
* Drug: TA-7284 High
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women age ≥20 years old Diagnosed with Type 2 diabetes mellitus at least 3 months before run-in period HbA1c of ≥7.0% and ≤10.0% Exclusion Criteria: Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus Past or current history of severe diabetic complications Fasting plasma glucose > 270 mg/dL before treatment start History of hereditary glucose-galactose malabsorption or primary renal glucosuria Patients requiring insulin therapy

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TA-7284 Low<br> | Drug: TA-7284 Low<br>* The patients will receive TA-7284-Low orally for 24 weeks.<br>|
| Experimental: TA-7284 High<br> | Drug: TA-7284 High<br>* The patients will receive TA-7284-High orally for 24 weeks.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* The patients will receive Placebo orally for 24 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value) |  | baseline and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fasting Plasma Glucose |  | Week 24 | 
| Change in Body Weight |  | Week 24 | 
| Change in Blood Pressure |  | Week 24 | 
| Change in Postprandial Plasma Glucose, Insulin and Urinary Glucose Excretion After a 75 g Oral Glucose Tolerance Test |  | Week 24 | 
| Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events, Laboratory Tests, 12-lead ECG and Vital Signs |  | Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TA-7284, JNJ-28431754, Canagliflozin, Sodium Glucose Co-transporter (SGLT2 inhibitor)