Clinical trial NCT02354235: Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Canagliflozin)
Official title: Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Canagliflozin in Patients With Inadequate Glycemic Control on Teneligliptin)
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: 138
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 Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 24 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Teneligliptin 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, MD
role: STUDY_DIRECTOR
affiliation: Mitsubishi Tanabe Pharma Corporation
name: Kazuoki Kondo, MD
role: STUDY_DIRECTOR
References:
citation: Kadowaki T, Inagaki N, Kondo K, Nishimura K, Kaneko G, Maruyama N, Nakanishi N, Iijima H, Watanabe Y, Gouda M. Efficacy and safety of canagliflozin as add-on therapy to teneligliptin in Japanese patients with type 2 diabetes mellitus: Results of a 24-week, randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2017 Jun;19(6):874-882. doi: 10.1111/dom.12898. Epub 2017 Mar 31.