Phase 3
Completed N=203
Monotherapy Study of MP-513 in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00998881 ↗Enrolled (actual)
203
Serious AEs
2.0%
Results posted
Feb 2014
Primary outcomePrimary: Change From Baseline in HbA1c at Week 12 — 0.17; -0.62 Percent
Summary
The purpose of this study is to evaluate the efficacy and safety of MP-513 (Teneligliptin) in patients with type 2 Diabetes for 12 weeks administration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c at Week 12 |
0.17; -0.62 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose at Week 12 |
-0.2; -19.2 | — |
| SECONDARY Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12 |
0.224; -73.124 | — |
| SECONDARY Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12 |
-3.2; -47.9 | — |
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 between 6.5% - 10.0%
- Patients who were not administered diabetes therapeutic drugs within 12 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 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.
- Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception
Data sourced from ClinicalTrials.gov (NCT00998881). 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.