Phase 3
Completed N=240
Long-term Safety Study of MP-513 as Monotherapy or in Combination With Sulfonylurea in Japanese Type 2 Diabetic Patients
Source: ClinicalTrials.gov NCT02314637 ↗Enrolled (actual)
240
Serious AEs
5.4%
Results posted
Jan 2015
Primary outcomePrimary: Number of Participants With Adverse Events — 6; 7; 136; 84 participants
Summary
The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as monotherapy or in combination with Sulfonylurea (glimepiride) in Japanese patients with type 2 Diabetes for 52 weeks administration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
6; 7; 136; 84 | — |
| SECONDARY Change From Baseline in HbA1c at Week 52 |
-0.63; -0.81 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose at Week 52 |
-12.4; -17.0 | — |
Eligibility Criteria
Inclusion Criteria
- In case of combination therapy with Sulfonylurea, patients who has been receiving a stable dose and regimen of sulfonylurea for diabetes over 12 weeks before administration of investigational drug
- Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
- HbA1c criteria:
- monotherapy: 6.9% - 10.5%
- combination therapy with Sulfonylurea: 7.4 - 10.5%
- 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 (NCT02314637). 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.