Phase 3
Completed N=462
Long-term Safety Study of MP-513 in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01301833 ↗Enrolled (actual)
462
Serious AEs
6.3%
Results posted
Aug 2015
Primary outcomePrimary: Number of Participants With Adverse Events — 14; 3; 6; 6 participants
Summary
The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as monotherapy or in combination with oral antihyperglycaemic agent in patients with type 2 Diabetes for 52 weeks administration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
14; 3; 6; 6; 182; 72 | — |
| SECONDARY Change From Baseline in HbA1c at Week 52 |
-0.63; -0.76; -0.78; -0.89 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose at Week 52 |
-11.7; -13.7; -12.7; -19.5 | — |
| SECONDARY Change From Baseline in Fasting Glucagon at Week 52 |
2.8; 5.3; 5.0; 6.9 | — |
| SECONDARY Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52 |
0.988; 0.211; -0.173; -0.330 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who has been receiving a stable dose and regimen of oral antihyperglycaemic agent (biguanide agent,α-glucosidase inhibitor,rapid insulin secretagogue) 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
- Patients whose HbA1c is between 6.5% - 10.0%
- 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 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 (NCT01301833). 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.