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

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: TA-7284 Low; Drug: TA-7284 High; Drug: Placebo

• Registration Number: NCT01413204
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-08-04
• Study First Submitted QC: 2011-08-08
• Study First Posted: 2011-08-10
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Results First Submitted: 2014-03-26
• Status Verified: 2014-05
• Results First Submitted QC: 2014-05-27
• Last Update Submitted: 2014-05-27
• Results First Posted: 2014-06-05
• Last Update Posted: 2014-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 272

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%

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TA-7284 Low	TA-7284 Low	-
TA-7284 High	TA-7284 High	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value)	baseline and 24 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Reserch site; 🇯🇵 Tohoku, Japan