Efficacy and Safety of MP-513 in Combination With Metformin in Patients With Type 2 Diabetes
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Type 2 Diabetes Mellitus |
| Intervention | Drug: MP-513 Lowest Dose and Metformin Drug: MP-513 Low Dose and Metformin Drug: MP-513 Medium Dose and Metformin Drug: MP-513 High Dose and Metformin Drug: Placebo and Metformin |
| Phase | Phase 2 |
| Sponsor | Mitsubishi Tanabe Pharma Corporation |
| Responsible Party | Mitsubishi Tanabe Pharma Corporation |
| ClinicalTrials.gov Identifier | NCT00971243 |
| First Received | September 1, 2009 |
| Last Updated | December 15, 2011 |
| Last verified | December 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 1, 2009 |
|---|---|
| Last Updated Date | December 15, 2011 |
| Start Date | August 2009 |
| Estimated Primary Completion Date | April 2011 |
| Current Primary Outcome Measures | Change in HbA1C [Time Frame: Weeks 24, 52] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Efficacy and Safety of MP-513 in Combination With Metformin in Patients With Type 2 Diabetes |
|---|---|
| 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 |
| Brief 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition | 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. Drug: 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. Drug: 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. Drug: 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. Drug: Placebo and Metformin Placebo tablets once a day, and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks. |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 448 |
| Estimated Completion Date | April 2011 |
| Estimated Primary Completion Date | April 2011 |
| Eligibility Criteria | 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. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Denmark, Germany, Hungary, Lithuania, Poland, Romania, United Kingdom |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00971243 |
|---|---|
| Other Study ID Numbers | MP-513-E07 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Mitsubishi Tanabe Pharma Corporation |
| Study Sponsor | Mitsubishi Tanabe Pharma Corporation |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: David Kerr, Dr Royal Bournemouth Hospital |
| Verification Date | December 2011 |
Locations[ + expand ][ + ]
| Denmark | Aalborg, Denmark |
|---|---|
| Denmark | Ballerup, Denmark |
| Denmark | Vejle, Denmark |
| Germany | Falkensee, Germany |
| Germany | Hamburg, Germany |
| Germany | Karlsruhe, Germany |
| Germany | Kiel, Germany |
| Germany | Ludwigshafen, Germany |
| Germany | Lübeck, Germany |
| Germany | Mainz, Germany |
| Hungary | Budapest, Hungary |
| Hungary | Békéscsaba, Hungary |
| Hungary | Gyöngyös, Hungary |
| Hungary | Kaposvár, Hungary |
| Hungary | Miskolc, Hungary |
| Hungary | Nyíregyháza, Hungary |
| Hungary | Semmelweis, Hungary |
| Hungary | Szentes, Hungary |
| Hungary | Szigetvár, Hungary |
| Hungary | Ádám, Hungary |
| Lithuania | Kaunas, Lithuania |
| Lithuania | Klaipeda, Lithuania |
| Lithuania | Vilnius, Lithuania |
| Poland | Gdansk, Poland |
| Poland | Krakow, Poland |
| Poland | Leszno, Poland |
| Poland | Lodz, Poland |
| Poland | Niemodlin, Poland |
| Poland | Plock, Poland |
| Poland | Warszawa, Poland |
| Poland | Wroclaw, Poland |
| Romania | Brasov, Romania |
| Romania | Bucharest, Romania |
| Romania | Bucuresti, Romania |
| Romania | Galati, Romania |
| Romania | Ploiesti, Romania |
| Romania | Timis, Romania |
| Romania | Timisoara, Romania |
| United Kingdom | Addlestone, United Kingdom |
| United Kingdom | Ayr, United Kingdom |
| United Kingdom | Bournemouth, United Kingdom |
| United Kingdom | East Sussex, United Kingdom |
| United Kingdom | Edinburgh, United Kingdom |
| United Kingdom | Oldham, United Kingdom |
| United Kingdom | York, United Kingdom |