Phase 3
Completed N=204
Efficacy and Safety Study of MP-513 in Combination With Thiazolidinedione in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01026194 ↗Enrolled (actual)
204
Serious AEs
4.7%
Results posted
Oct 2013
Primary outcomePrimary: Change From Baseline in HbA1c at Week 12 — -0.20; -0.94 Percent of HbA1c
Summary
The purpose of this study is to evaluate the efficacy and safety of MP-513 (Teneligliptin) in combination with thiazolidinedione (pioglitazone) in patients with type 2 Diabetes for 12 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with thiazolidinedione with an extension treatment for up to 52 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c at Week 12 |
-0.20; -0.94 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose at Week 12 |
-4.5; -21.0 | — |
| SECONDARY Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12 |
-13.722; -85.031 | — |
| SECONDARY Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12 |
-5.6; -56.9 | — |
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% and 10.0%
- Patients who took Thiazolidinedione for diabetes over 16 weeks before administration of investigational drug
- Patients who were not administered diabetes therapeutic 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 impairment, or secondary diabetes (Cushing disease, acromegaly, etc)
- Patients who are accepting treatments of arrhythmias
- Patients with serious diabetic complications
- Patients who are the excessive alcohol addicts
- 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 (NCT01026194). 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.