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

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborators: Chonbuk National University; Chonnam National University; Chungnam National University; Eulji University; Hallym University; Korea University; Kyungpook National University; Kyungpook National University Hospital; Pusan National University College of Medicine; Seoul St. Mary's Hospital; Sungkyunkwan University; The Catholic University of Korea; Uijeongbu St. Mary Hospital; Yonsei University
• Treatments: Metformin; Mitiglinide

Criteria

Inclusion Criteria:

• aged 30-70 years

• had a duration of diabetes of <10 years

• body mass index (BMI) 20-35 kg/m2

• a plasma HbA1c level of 7.5-11% during the previous 4 weeks

Exclusion Criteria:

• subjects who were diagnosed with type 1 diabetes, gestational diabetes, or diabetes with any specific causes

• Subjects who had been treated with nateglinide, repaglinide, metformin (over 1,000 mg/day), or sulfonylurea (over a quarter of the maximum recommended dose) during the previous 8 weeks