Phase 3
Completed N=138
Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Canagliflozin)
Source: ClinicalTrials.gov NCT02354235 ↗Enrolled (actual)
138
Serious AEs
2.2%
Results posted
Aug 2018
Primary outcomePrimary: Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) — -0.97; -0.10 percentage of HbA1c — p=<0.001
◆ Published Evidence
Established
57citations · ~6 / year
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.
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.
Linked Publications
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) |
-0.97; -0.10 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose Level |
-34.9; 3.9 | <0.001 sig |
| SECONDARY Percentage Change in Body Weight From Baseline |
-3.32; -0.99 | <0.001 sig |
| SECONDARY Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG) |
-105.9; -5.6 | <0.001 sig |
| SECONDARY Change From Baseline in 2-hour Postprandial Plasma Glucose Level |
-60.1; -9.2 | <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 (NCT02354235) 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.