Back to resultsEffect of Combination of Mitiglinide and Metformin on Glycemic Control in Patients With Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Mitiglinide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility 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
Sites / Locations
- Pusan National University College of Medicine
- Kyungpook National University School of Medicine
- Chungnam National University College of Medicine
- Chonnam National University College of Medicine
- Chonbuk National University College of Medicine
- Eulji University School of Medicine
- Hallym University College of Medicine
- Korea University College of Medicine
- Seoul St. Mary's Hospital
- SungKyunKwan University School of Medicine
- The Catholic University of Korea
- Yonsei University College of Medicine
- Uijeongbu St. Mary Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Metformin+Mitiglinide
Metformin+Placebo
Arm Description
mitiglinide 10 mg three times a day added to metformin 500 mg three times a day
placebo three times a day added to metformin 500 mg three times a day
Outcomes
Primary Outcome Measures
the change in HbA1c from randomization to endpoint
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
Full Information
NCT ID
NCT01037842
First Posted
December 19, 2009
Last Updated
December 19, 2009
Sponsor
Seoul National University Hospital
Collaborators
Seoul St. Mary's Hospital, The Catholic University of Korea, Uijeongbu St. Mary Hospital, Korea University, Kyungpook National University Hospital, Pusan National University College of Medicine, Sungkyunkwan University, Yonsei University, Eulji University, Chonnam National University, Chonbuk National University, Chungnam National University, Hallym University
1. Study Identification
Unique Protocol Identification Number
NCT01037842
Brief Title
Effect of Combination of Mitiglinide and Metformin on Glycemic Control in Patients With Type 2 Diabetes Mellitus
Official Title
Phase 3 Study of Combination of Mitiglinide and Metformin in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Seoul National University Hospital
Collaborators
Seoul St. Mary's Hospital, The Catholic University of Korea, Uijeongbu St. Mary Hospital, Korea University, Kyungpook National University Hospital, Pusan National University College of Medicine, Sungkyunkwan University, Yonsei University, Eulji University, Chonnam National University, Chonbuk National University, Chungnam National University, Hallym University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
145 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metformin+Mitiglinide
Arm Type
Active Comparator
Arm Description
mitiglinide 10 mg three times a day added to metformin 500 mg three times a day
Arm Title
Metformin+Placebo
Arm Type
Placebo Comparator
Arm Description
placebo three times a day added to metformin 500 mg three times a day
Intervention Type
Drug
Intervention Name(s)
Mitiglinide
Intervention Description
mitiglinide 10 mg three times a day added to metformin 500 mg three times a day
for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo three times a day added to metformin 500 mg three times a day for 16 weeks
Primary Outcome Measure Information:
Title
the change in HbA1c from randomization to endpoint
Time Frame
16 weeks after radomization
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Pusan National University College of Medicine
City
Busan
Country
Korea, Republic of
Facility Name
Kyungpook National University School of Medicine
City
Daegu
Country
Korea, Republic of
Facility Name
Chungnam National University College of Medicine
City
Daejeon
Country
Korea, Republic of
Facility Name
Chonnam National University College of Medicine
City
Gwangju
Country
Korea, Republic of
Facility Name
Chonbuk National University College of Medicine
City
Jeonju
Country
Korea, Republic of
Facility Name
Eulji University School of Medicine
City
Seoul
Country
Korea, Republic of
Facility Name
Hallym University College of Medicine
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University College of Medicine
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
SungKyunKwan University School of Medicine
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of
Facility Name
Uijeongbu St. Mary Hospital
City
Uijeongbu
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Combination of Mitiglinide and Metformin on Glycemic Control in Patients With Type 2 Diabetes Mellitus
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