Clinical trial NCT02354222: Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Teneligliptin)
Official title: Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Teneligliptin in Patients With Inadequate Glycemic Control on Canagliflozin)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: MT-2412
MP-513
TA-7284
Teneligliptin
Canagliflozin
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2015-02-03
Enrollment: 154
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
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 co-administration of Canagliflozin (TA-7284) and Teneligliptin (MP-513) once daily for 24 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Canagliflozin and have inadequate glycemic control.


Eligibility criteria: Inclusion Criteria:

* Men or women who are 20 - 75 years old
* HbA1c of ≥7.0% and \<10.5%
* FPG of ≤ 270 mg/dL
* Patients who are under dietary management and taking therapeutic exercise for diabetes over 8 weeks before run-in period

Exclusion Criteria:

* Patients with type I diabetes, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes
* Patients with serious diabetic complications
* Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria
* Patients with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification
* Patients with severe hepatic disorder or severe renal disorder.

Primary outcomes:
measure: Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)
timeFrame: Baseline, 24 Weeks
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose Level
timeFrame: Baseline, 24 Weeks
measure: Percentage Change in Body Weight From Baseline
timeFrame: Baseline, 24 Weeks
measure: Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG)
timeFrame: 0, 0.5, 1 and 2 hour postprandial, at Baseline and 24 Weeks
measure: Change From Baseline in 2-hour Postprandial Plasma Glucose Level
timeFrame: 2 Hours Postprandial, at Baseline and 24 Weeks
Other outcomes:
Locations:
city: Kanto
country: Japan
facility: Reserch site
city: Kinki
country: Japan
facility: Reserch site
city: Tohoku
country: Japan
facility: Reserch site
Study officials:
affiliation: Tokyo University
name: Takashi Kadowaki, M.D.
role: STUDY_DIRECTOR
affiliation: Mitsubishi Tanabe Pharma Corporation
name: Kazuoki Kondo, M.D.
role: STUDY_DIRECTOR
References:
citation: Kadowaki T, Inagaki N, Kondo K, Nishimura K, Kaneko G, Maruyama N, Nakanishi N, Gouda M, Iijima H, Watanabe Y. Efficacy and safety of teneligliptin added to canagliflozin monotherapy in Japanese patients with type 2 diabetes mellitus: A multicentre, randomized, double-blind, placebo-controlled, parallel-group comparative study. Diabetes Obes Metab. 2018 Feb;20(2):453-457. doi: 10.1111/dom.13079. Epub 2017 Sep 15.