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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01072331
• Other study ID #: 3000-A12
• Status: Completed
• Phase: Phase 3
• First received: February 18, 2010
• Last updated: April 2, 2013
• Start date: February 2010
• Est. completion date: August 2010

Study information

• Verified date: April 2013
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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.

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• MP-513
MP-513 10 mg, once a day, for 4 weeks
• MP-513
MP-513 20 mg, once a day, for 4 weeks
• Placebo of MP-513
MP-513 placebo, once a day, for 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Eto T, Inoue S, Kadowaki T. Effects of once-daily teneligliptin on 24-h blood glucose control and safety in Japanese patients with type 2 diabetes mellitus: a 4-week, randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2012 Nov;14(11) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in 2-h Postprandial Glucose (Breakfast, Lunch and Dinner)		4 weeks	No
Primary	Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 to 2h (Breakfast, Lunch and Dinner)		4 weeks	No
Secondary	Change From Baseline in 24-h Mean Glucose		4 weeks	No
Secondary	Change From Baseline in Fasting Plasma Glucose		4 weeks	No