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Completed

NCT Number: NCT01037842

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

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).

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pusan National University College of Medicine, Busan, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mitiglinide

Drug

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

for 16 weeks

Placebo

Drug

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

Primary outcomes

  1. the change in HbA1c from randomization to endpoint

    Time frame: 16 weeks after radomization

Secondary outcomes

  1. 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

    Time frame: 16 weeks after radomization

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Chonbuk National University
  • Chonnam National University
  • Chungnam National University
  • Eulji University
  • Hallym University
  • Korea 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

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 23, 2009
Registry last updated
Dec 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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