Phase 3
Completed N=153
Long-Term Safety Study of MT-2412 in Japanese Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT02220907 ↗Enrolled (actual)
153
Serious AEs
7.2%
Results posted
Aug 2018
Primary outcomePrimary: Number of Participants With Adverse Events — 11; 107 participants
◆ Published Evidence
Emerging
15citations · ~2 / year
Long-term safety and efficacy of canagliflozin as add-on therapy to teneligliptin in Japanese patients with type 2 diabetes.
Summary
The purpose of this study is to evaluate the safety and efficacy of co-administration of Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 52 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Teneligliptin and have inadequate glycemic control.
Linked Publications
-
Long-term safety and efficacy of canagliflozin as add-on therapy to teneligliptin in Japanese patients with type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
11; 107 | — |
| SECONDARY Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) |
-0.99 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose Level |
-38.6 | — |
| SECONDARY Percentage Change in Body Weight From Baseline |
-3.92 | — |
Eligibility Criteria
Inclusion Criteria
- Men or women age ≥20 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 12 weeks before treatment 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 (NCT02220907) 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.