Phase 3
Completed N=154
Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Teneligliptin)
Source: ClinicalTrials.gov NCT02354222 ↗Enrolled (actual)
154
Serious AEs
2.0%
Results posted
Aug 2018
Primary outcomePrimary: Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) — -0.94; 0.00 percentage of HbA1c — p=<0.001
◆ Published Evidence
Established
31citations · ~4 / year
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.
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.
Linked Publications
-
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) |
-0.94; 0.00 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose Level |
-5.6; 10.0 | <0.001 sig |
| SECONDARY Percentage Change in Body Weight From Baseline |
0.09; -1.34 | <0.001 sig |
| SECONDARY Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG) |
-50.2; 5.7 | <0.001 sig |
| SECONDARY Change From Baseline in 2-hour Postprandial Plasma Glucose Level |
-35.3; 2.3 | <0.001 sig |
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.
Data sourced from ClinicalTrials.gov (NCT02354222) 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.