Phase 2
Completed N=447
Efficacy and Safety of MP-513 in Combination With Metformin in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00971243 ↗Enrolled (actual)
447
Serious AEs
4.9%
Results posted
Sep 2014
Primary outcomePrimary: Change in HbA1c From Baseline to Week 24 — -0.58; -0.68; -0.76; -0.91 percentage of HbA1c
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline to Week 24 |
-0.58; -0.68; -0.76; -0.91; -0.28 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24 |
-15.54; -13.65; -17.84; -21.85; -3.51 | — |
| SECONDARY Adverse Events, Laboratory Tests, Vital Signs, Etc. |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT00971243). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.