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

Phase 3 Study of Combination of Mitiglinide and Metformin in Patients With Type 2 Diabetes Mellitus

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01037842

Enrollment

145

Registered

2009-12-23

Start date

2006-08-31

Completion date

2008-05-31

Last updated

2009-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Brief 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).

Detailed 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.

Interventions

DRUGMitiglinide

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

30 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
the change in HbA1c from randomization to endpoint	16 weeks after radomization

Secondary

Measure	Time frame
the proportion of subjects with HbA1c <7% after 16 weeks of treatment and the change in FPG and 2-hr postprandial glucose (PPG) from baseline	16 weeks after radomization

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026