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

Study Overview
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Mitiglinide
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metformin+Mitiglinide<br>mitiglinide 10 mg three times a day added to metformin 500 mg three times a day | Drug: Mitiglinide<br>* mitiglinide 10 mg three times a day added to metformin 500 mg three times a day for 16 weeks<br>|
| Placebo Comparator: Metformin+Placebo<br>placebo three times a day added to metformin 500 mg three times a day | Drug: Placebo<br>* placebo three times a day added to metformin 500 mg three times a day for 16 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change in HbA1c from randomization to endpoint |  | 16 weeks after radomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |