Efficacy and Safety of MP-513 in Combination With Metformin in Patients With Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Phase IIb, Double-blind, Parallel Group, Multi-center, Dose-finding Study to Investigate the Efficacy and Safety of 4 Doses of MP-513 When Added to Ongoing Metformin Monotherapy in Subjects With Type 2 Diabetes Mellitus, With an Open Label Extension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00971243
• Other study ID #: MP-513-E07
• Status: Completed
• Phase: Phase 2
• First received: September 1, 2009
• Last updated: August 21, 2014
• Start date: August 2009
• Est. completion date: April 2011

Study information

• Verified date: August 2014
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of HealthHungary: National Institute of PharmacyRomania: National Medicines AgencyLithuania: State Medicine Control Agency - Ministry of HealthGermany: Federal Institute for Drugs and Medical DevicesDenmark: Danish Medicines AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of MP-513 in combination with Metformin in patients with type 2 diabetes for 24 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with Metformin with an extension treatment for up to 52 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 448
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who are aged ? 18 years old.

• Patients whose HbA1c is ? 7.0 % and < 10.0%.

• Patients whose BMI is ? 20.0 and ?40.0 ?/?.

• Patients who took metformin monotherapy for at least 56 consecutive days at the screening visit.

Exclusion Criteria:

• Patients with type 1 diabetes or secondary form of diabetes.

• Patients with heart failure symptoms.

• Patients with serious diabetic complications.

• Patients with severe hepatic disorder or severe renal disorder.

• Patients who are the excessive alcohol addicts.

• 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 Lowest Dose and Metformin
MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
• MP-513 Low Dose and Metformin
MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
• MP-513 Medium Dose and Metformin
MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
• MP-513 High Dose and Metformin
MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
• Placebo and Metformin
Placebo tablets once a day, and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Countries where clinical trial is conducted

Denmark,  Germany,  Hungary,  Lithuania,  Poland,  Romania,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c From Baseline to Week 24	The change of HbA1c from baseline to Week 24 or a last observation carried forward (LOCF), was assessed with an analysis of covariance (ANCOVA) model, with the centre and treatment effect as factors and the baseline HbA1c as a covariate.	Baseline and Week 24	No
Secondary	Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24	Change in FPG from baseline to Week 24 or LOCF was assessed with an ANCOVA approach similar to that of the primary efficacy endpoint.	Baseline and Week 24	No
Secondary	Adverse Events, Laboratory Tests, Vital Signs, Etc.		Weeks 24, 52	Yes