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

This study has been completed.
Sponsor:
Collaborators:
Seoul St. Mary's Hospital
The Catholic University of Korea
UiJeungbu St.Mary's Hospital
Korea University
Kyungpook National University
Pusan National University College of Medicine
Sungkyunkwan University School of Medicine
Yonsei University College of Medicine
Eulji University
Chonnam National University
Chonbuk National University
Chungnam National University
Hallym University
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01037842
First received: December 19, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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).


Condition Intervention Phase
Type 2 Diabetes
 Drug: Mitiglinide
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Combination of Mitiglinide and Metformin in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • the change in HbA1c from randomization to endpoint [ Time Frame: 16 weeks after radomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 145
Study Start Date: August 2006
Study Completion Date: May 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metformin+Mitiglinide
mitiglinide 10 mg three times a day added to metformin 500 mg three times a day
 Drug: Mitiglinide

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

for 16 weeks
Placebo Comparator: Metformin+Placebo
placebo three times a day added to metformin 500 mg three times a day
 Drug: Placebo
placebo three times a day added to metformin 500 mg three times a day for 16 weeks

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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01037842

Locations
Korea, Republic of
Pusan National University College of Medicine
Busan, Korea, Republic of
Kyungpook National University School of Medicine
Daegu, Korea, Republic of
Chungnam National University College of Medicine
Daejeon, Korea, Republic of
Chonnam National University College of Medicine
Gwangju, Korea, Republic of
Chonbuk National University College of Medicine
Jeonju, Korea, Republic of
The Catholic University of Korea
Seoul, Korea, Republic of
Hallym University College of Medicine
Seoul, Korea, Republic of
Yonsei University College of Medicine
Seoul, Korea, Republic of
Korea University College of Medicine
Seoul, Korea, Republic of
Seoul St. Mary's Hospital
Seoul, Korea, Republic of
Eulji University School of Medicine
Seoul, Korea, Republic of
SungKyunKwan University School of Medicine
Seoul, Korea, Republic of
Uijeongbu St. Mary Hospital
Uijeongbu, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Seoul St. Mary's Hospital
The Catholic University of Korea
UiJeungbu St.Mary's Hospital
Korea University
Kyungpook National University
Pusan National University College of Medicine
Sungkyunkwan University School of Medicine
Yonsei University College of Medicine
Eulji University
Chonnam National University
Chonbuk National University
Chungnam National University
Hallym University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01037842     History of Changes
Other Study ID Numbers: IMMEDIATE
Study First Received: December 19, 2009
Last Updated: December 19, 2009
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Mitiglinide
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013