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

Seoul National University

Status and phase

Completed

Phase 3

Conditions

Type 2 Diabetes

Treatments

Drug: Mitiglinide

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01037842

IMMEDIATE

Details and patient eligibility

About

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).

Full description

This was a 16-week, randomized, double-blind study for comparing metformin plus mitiglinide (Met+Mit) versus metformin plus placebo (Met+Pcb). An 8-week metformin run-in phase (500 mg twice a day for the first 4 weeks and 500 mg three times a day for the following 4 weeks) was followed by a 16-week trial phase (mitiglinide 10 mg or placebo three times a day added to metformin 500 mg three times a day). The subjects with an HbA1c >7.0% at the end of the metformin run-in phase were randomized to a Met+Mit group or a Met+Pcb group of the trial phase.

Enrollment

145 patients

Sex

All

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

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