drugset / Trial / NCT01037842
Effect of Combination of Mitiglinide and Metformin on Glycemic Control in Patients With Type 2 Diabetes Mellitus
Phase 3
Completed
145 enrolled
Seoul National University Hospital
Chonbuk National University · collabChonnam National University · collabChungnam National University · collabEulji University · collabHallym University · collabKorea University · collabKyungpook National University Hospital · collabPusan National University College of Medicine · collabSeoul St. Mary's Hospital · collabSungkyunkwan University · collabThe Catholic University of Korea · collabUijeongbu St. Mary Hospital · collabYonsei University · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
We performed a prospective, randomized, multicenter trial to assess the efficacy and safety of combined treatment with mitiglinide and metformin for patients with type 2 diabetes who show inadequate glycemic control with metformin monotherapy. Subjects with HbA1c \>7.0% after an 8-week metformin run-in phase were randomized to a 16-week trial phase with metformin plus mitiglinide (Met+Mit) or metformin plus placebo (Met).
Timeline
- Start
- 2006-08
- Primary completion
- 2008-03
- Completion
- 2008-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Mitiglinide | Small molecule | 10 mg | — |