Effect of Combination of Mitiglinide and Metformin on Glycemic Control in Patients With Type 2 Diabetes Mellitus
- Registration Number
- NCT01037842
- Lead Sponsor
- Seoul National University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 145
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metformin+Placebo Placebo placebo three times a day added to metformin 500 mg three times a day Metformin+Mitiglinide Mitiglinide mitiglinide 10 mg three times a day added to metformin 500 mg three times a day
- Primary Outcome Measures
Name Time Method the change in HbA1c from randomization to endpoint 16 weeks after radomization
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (13)
Kyungpook National University School of Medicine
🇰🇷Daegu, Korea, Republic of
Yonsei University College of Medicine
🇰🇷Seoul, Korea, Republic of
Chungnam National University College of Medicine
🇰🇷Daejeon, Korea, Republic of
Chonnam National University College of Medicine
🇰🇷Gwangju, Korea, Republic of
SungKyunKwan University School of Medicine
🇰🇷Seoul, Korea, Republic of
Chonbuk National University College of Medicine
🇰🇷Jeonju, Korea, Republic of
Eulji University School of Medicine
🇰🇷Seoul, Korea, Republic of
Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Pusan National University College of Medicine
🇰🇷Busan, Korea, Republic of
Uijeongbu St. Mary Hospital
🇰🇷Uijeongbu, Korea, Republic of
The Catholic University of Korea
🇰🇷Seoul, Korea, Republic of
Hallym University College of Medicine
🇰🇷Seoul, Korea, Republic of
Korea University College of Medicine
🇰🇷Seoul, Korea, Republic of