Clinical trial NCT02081599: Efficacy and Safety Study of Teneligliptin (MP-513) in Combination With Insulin in Patients With Type 2 Diabetes
Official title: A Phase IV Study of Teneligliptin (MP-513) in Combination With Insulin in Japanese Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: insulin resistance
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2014-03-07
Enrollment: 148
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Change From Baseline in HbA1c
timeFrame: at Week 0 and Week 16
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose
timeFrame: at Week 0 and Week 16
measure: Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose
timeFrame: 0, 0.5, 1, 2 hours post-dose at Week 0 and Week 16
measure: Change From Baseline in 2-hour Postprandial Plasma Glucose
timeFrame: at Week 0 and Week 16
Other outcomes:
Locations:
city: Chuo-ku
country: Japan
facility: Investigational site
state: Tokyo
Study officials:
affiliation: Tokyo University
name: Takashi Kadowaki, Professor
role: STUDY_DIRECTOR
affiliation: Mitsubishi Tanabe Pharma Corporation
name: Kazuoki Kondo, MD
role: STUDY_DIRECTOR
References:
citation: Kadowaki T, Kondo K, Sasaki N, Miyayama K, Yokota S, Terata R, Gouda M. 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. Expert Opin Pharmacother. 2017 Sep;18(13):1291-1300. doi: 10.1080/14656566.2017.1359259. Epub 2017 Aug 10.