Phase 2
Completed N=324
Efficacy and Safety Study of MP-513 in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00628212 ↗Enrolled (actual)
324
Serious AEs
0.3%
Results posted
May 2013
Primary outcomePrimary: Change From Baseline in HbA1c at Week 12 — 0.11; -0.77; -0.80; -0.91 Percent
Summary
The purpose of this study is to evaluate the efficacy and safety and to determine the appropriate dose for phase 3 confirmatory trial, of MP-513 (Teneligliptin) in patients with type 2 Diabetes based on the change of HbA1c and adverse events after 12 weeks administration once daily in multi-center, randomized, double-blind, placebo-controlled, parallel assignment manner.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c at Week 12 |
0.11; -0.77; -0.80; -0.91 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose at Week 12 |
2.8; -15.0; -14.1; -17.2 | — |
| SECONDARY Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12 |
7.3; -43.3; -49.4; -51.3 | — |
| SECONDARY Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12 |
5.897; -65.445; -73.211; -75.326 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who are 20 - 75 years old
- Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
- Patients whose HbA1c is 6.5 - 9.5%
- Patients who were not administered drugs prohibited for concomitant use within 12 weeks before administration of investigational drug.
Exclusion Criteria
- Patients with type 1 diabetes, diabetes mellitus caused by pancreas failure, or secondary diabetes (Cushing disease, acromegaly, etc)
- Patients with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification
- Patients with serious diabetic complications
- Patients who are habitual excessive alcohol consumption.
- Patients with severe hepatic disorder or severe renal disorder.
- Pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception
Data sourced from ClinicalTrials.gov (NCT00628212). 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.