Effect of Combination of Mitiglinide and Metformin on Glycemic Control in Patients With Type 2 Diabetes Mellitus

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).

Conditions

• Type 2 Diabetes

Interventions

DRUG

Mitiglinide

mitiglinide 10 mg three times a day added to metformin 500 mg three times a day for 16 weeks

DRUG

Placebo

placebo three times a day added to metformin 500 mg three times a day for 16 weeks

Sponsors & Collaborators

• Seoul St. Mary's Hospital

  collaborator OTHER

• The Catholic University of Korea

  collaborator OTHER

• Uijeongbu St. Mary Hospital

  collaborator OTHER

• Korea University

  collaborator OTHER

• Kyungpook National University Hospital

  collaborator OTHER

• Pusan National University College of Medicine

  collaborator UNKNOWN

• Sungkyunkwan University

  collaborator OTHER

• Yonsei University

  collaborator OTHER

• Eulji University

  collaborator OTHER

• Chonnam National University

  collaborator OTHER

• Chonbuk National University

  collaborator OTHER

• Chungnam National University

  collaborator OTHER

• Hallym University

  collaborator OTHER

• Seoul National University Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-08-31

Primary Completion

2008-03-31

Completion

2008-05-31

Countries

• South Korea

Study Locations