Pharmacokinetic/Pharmacodynamic Study of MP-513 With Type 2 Diabetes Mellitus

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: MP-513; Drug: Placebo of MP-513

• Registration Number: NCT01072331
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

The purpose of this study is to evaluate the effect of MP-513 on 24-h glycemic control in patients with type 2 Diabetes for 4 weeks administration.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-18
• Study First Submitted QC: 2010-02-18
• Study First Posted: 2010-02-22
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Results First Submitted: 2012-11-20
• Results First Submitted QC: 2012-11-20
• Results First Posted: 2012-12-19
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-02
• Last Update Posted: 2013-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• Patients who are 20 - 75 years old
• Patients who are under dietary management and taking therapeutic exercise for diabetes over 8 weeks before administration of investigational drug
• Patients whose HbA1c is ≥6.5% and <10.0%
• Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 8 weeks before administration of investigational drug.

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Exclusion Criteria

• Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc)
• Patients who are accepting treatments of arrhythmias
• Patients with serious diabetic complications
• Patients who are the excessive alcohol addicts
• Patients with severe hepatic disorder or severe renal disorder.
• Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MP-513 10 mg, once a day, for 4 weeks	MP-513	-
MP-513 20 mg, once a day, for 4 weeks	MP-513	-
Placebo of MP-513	Placebo of MP-513	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in 2-h Postprandial Glucose (Breakfast, Lunch and Dinner)	4 weeks
Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 to 2h (Breakfast, Lunch and Dinner)	4 weeks

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in 24-h Mean Glucose	4 weeks
Change From Baseline in Fasting Plasma Glucose	4 weeks