Phase 3
Completed N=247
Efficacy and Safety of Teneligliptin in Combination With Metformin in Chinese Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT02924064 ↗Enrolled (actual)
247
Serious AEs
4.1%
Results posted
Jan 2022
Primary outcomePrimary: The Changes in HbA1c at Week 24 — -0.72; -0.01 percentage of HbA1c
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study is designed as a prospective, multi-centre, parallel group, double-blind randomized, placebo-controlled, phase 3 clinical study to evaluate the efficacy and safety of MP-513 (Teneligliptin) in combination with metformin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Changes in HbA1c at Week 24 |
-0.72; -0.01 | — |
| SECONDARY The Changes in Fasting Plasma Glucose (FPG) at Week 24 |
-13.5; 3.0 | — |
Eligibility Criteria
Inclusion Criteria
- A signed and dated informed consent form obtained from the subject, in accordance.
- The subject is aged ≥18 years at signature of the informed consent form.
- Hospitalization status: outpatient.
- The subject has a documented diagnosis of type 2 diabetes mellitus for at least 3 months at the screening visit (Day -28).
- The subject's type 2 diabetes mellitus is managed by metformin monotherapy ≥1000 mg/day plus diet and exercise therapy, and the dosage or dose regimen of metformin and diet and exercise regimen has not been changed for at least 8 consecutive weeks at the screening visit (Day -28). Subjects who cannot do exercise due to complication are not limited to this criteria.
- The subject's HbA1c is ≥ 7.0% and < 10.0% at the screening visit (Day -28) and on Day -14.
Exclusion Criteria
- The subject has a history of type 1 diabetes mellitus or a secondary form of diabetes.
- The subject has received insulin within 1 year prior to the screening visit (Day -28), with the exception of insulin therapy during hospitalization or insulin therapy for medical conditions not requiring hospitalization (< 2 weeks' duration).
- The subject has received an anti-diabetic drug within 8 weeks prior to the screening visit (Day -28).
Data sourced from ClinicalTrials.gov (NCT02924064). 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.