At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 324 enrolled
Drug / intervention
Teneligliptin 10mg +3 moredrug
Likely dose
Teneligliptin 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Double-Blind, Placebo-Controlled, Monotherapy Study of MP-513 in Japanese Patients With Type 2 Diabetes Mellitus -Confirmative Study-
In Brief
A Phase 2 clinical trial evaluating Teneligliptin 10mg, Teneligliptin 20 mg, and 2 other interventions for Type 2 Diabetes. Completed, enrolled 324 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety and to determine the appropriate dose for phase 3 confirmatory trial, of MP-513 (Teneligliptin) in patients with type 2 Diabetes based on the change of HbA1c and adverse events after 12 weeks administration once daily in multi-center, randomized, double-blind, placebo-controlled, parallel assignment manner.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesJapan
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2008
First PostedMar 2008
Primary CompletionDec 2008
Study CompletionJan 2009
TodayJul 2026
First PostedMar 4, 2008
Enrollment StartJan 1, 2008
Primary CompletionDec 1, 2008
Study CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 18.3 years ago
Interventions
Teneligliptin 10mgdrug
Teneligliptin 20 mgdrug
Teneligliptin 40 mgdrug
Placebodrug