Phase 4
Completed N=148
Efficacy and Safety Study of Teneligliptin (MP-513) in Combination With Insulin in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT02081599 ↗Enrolled (actual)
148
Serious AEs
4.5%
Results posted
Jan 2017
Primary outcomePrimary: Change From Baseline in HbA1c — -0.07; -0.87 percentage of HbA1c
◆ Published Evidence
Established
25citations · ~3 / year
Efficacy and safety of teneligliptin add-on to insulin monotherapy in Japanese patients with type 2 diabetes mellitus: a 16-week, randomized, double-blind, placebo-controlled trial with an open-label period.
Summary
The purpose of this study is to evaluate the efficacy and safety of Teneligliptin in combination with Insulin in patients with type 2 Diabetes for 16 weeks administration and to evaluate the safety and efficacy of Teneligliptin in combination with Insulin with an extension treatment for up to 52 weeks.
Linked Publications
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Efficacy and safety of teneligliptin add-on to insulin monotherapy in Japanese patients with type 2 diabetes mellitus: a 16-week, randomized, double-blind, placebo-controlled trial with an open-label period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c |
-0.07; -0.87 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose |
8.0; -5.4 | — |
| SECONDARY Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose |
9.827; -54.035 | — |
| SECONDARY Change From Baseline in 2-hour Postprandial Plasma Glucose |
3.0; -42.9 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who has been receiving a stable dose and regimen of insulin 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 7.5% and 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 (NCT02081599) and the linked publication. 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.