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

NCT ID: NCT01037842

Last Updated: 2009-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-05-31

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Metformin+Mitiglinide

mitiglinide 10 mg three times a day added to metformin 500 mg three times a day

Group Type ACTIVE_COMPARATOR

Mitiglinide

Intervention Type DRUG

mitiglinide 10 mg three times a day added to metformin 500 mg three times a day

for 16 weeks

Metformin+Placebo

placebo three times a day added to metformin 500 mg three times a day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Mitiglinide

mitiglinide 10 mg three times a day added to metformin 500 mg three times a day

for 16 weeks

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul St. Mary's Hospital

OTHER

Sponsor Role collaborator

The Catholic University of Korea

OTHER

Sponsor Role collaborator

Uijeongbu St. Mary Hospital

OTHER

Sponsor Role collaborator

Korea University

OTHER

Sponsor Role collaborator

Kyungpook National University Hospital

OTHER

Sponsor Role collaborator

Pusan National University College of Medicine

UNKNOWN

Sponsor Role collaborator

Sungkyunkwan University

OTHER

Sponsor Role collaborator

Yonsei University

OTHER

Sponsor Role collaborator

Eulji University

OTHER

Sponsor Role collaborator

Chonnam National University

OTHER

Sponsor Role collaborator

Chonbuk National University

OTHER

Sponsor Role collaborator

Chungnam National University

OTHER

Sponsor Role collaborator

Hallym University

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Locations

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Pusan National University College of Medicine

Busan, , South Korea

Site Status

Kyungpook National University School of Medicine

Daegu, , South Korea

Site Status

Chungnam National University College of Medicine

Daejeon, , South Korea

Site Status

Chonnam National University College of Medicine

Gwangju, , South Korea

Site Status

Chonbuk National University College of Medicine

Jeonju, , South Korea

Site Status

Eulji University School of Medicine

Seoul, , South Korea

Site Status

Hallym University College of Medicine

Seoul, , South Korea

Site Status

Korea University College of Medicine

Seoul, , South Korea

Site Status

Seoul St. Mary's Hospital

Seoul, , South Korea

Site Status

SungKyunKwan University School of Medicine

Seoul, , South Korea

Site Status

The Catholic University of Korea

Seoul, , South Korea

Site Status

Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Uijeongbu St. Mary Hospital

Uijeongbu-si, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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IMMEDIATE

Identifier Type: -

Identifier Source: org_study_id