Long-Term Safety Study of TA-7284 in Patients With Type 2 Diabetes Mellitus

Phase 3

Completed

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

• Registration Number: NCT01387737
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of TA-7284 as monotherapy or combination therapy with other oral anti-hyperglycaemic agent in Japanese patients with Type 2 diabetes mellitus on 52 weeks oral administration.

Detailed Description

This is a randomized, 2-arm, parallel group, open-label study to evaluate the safety and efficacy of TA-7284 in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise or with oral anti-hyperglycaemic agent. The patients will receive either TA-7284-Low or TA-7284-High orally alone or in combination with oral anit-hyperglycaemic agent for 52 weeks.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-06-28
• Study First Submitted QC: 2011-06-30
• Study First Posted: 2011-07-06
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Results First Submitted: 2014-03-26
• Results First Submitted QC: 2014-03-26
• Results First Posted: 2014-04-28
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-27
• Last Update Posted: 2014-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1299

Inclusion Criteria

• Men or women age ≥20 years old
• Diagnosed with Type 2 diabetes mellitus at least 3 months before screening
• HbA1c of ≥7.0% and ≤10.0% (monotherapy group)
• HbA1c of ≥7.0% and ≤10.5% (combination therapy group)

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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	-

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events	54 weeks

Secondary Outcome Measures

Name	Time	Method
Change in HbA1c	Week 52
Change in Fasting Plasma Glucose	Week 52
Change in Body Weight	Week 52
Change in Blood Pressure	Week 52

Trial Locations

Locations (1)

Research site; 🇯🇵 Tohoku, Japan