Mitiglinide in Combination With Metformin vs. Metformin Alone in Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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The primary objective of this study is to demonstrate whether mitiglinide administered in combination with metformin is more effective than metformin alone in patients with Type 2 diabetes mellitus (T2DM) whose blood sugar is not well controlled taking metformin alone. This is a 24 week study which measures improvement in blood sugar after of treatment.

Detailed Description
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This is a randomized, double-blind, placebo-controlled, parallel group study designed to evaluate the efficacy and safety of mitiglinide in combination with metformin in patients with T2DM who are less than adequately controlled on metformin alone. Patients who are receiving metformin alone for T2DM will be randomized equally into one of three treatment groups.

Official Title
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A Rapid Onset and Short Duration Insulin Secretogogue, Mitiglinide, in Combination With Metformin Versus Metformin Alone in Patients With Type 2 Diabetes Mellitus: A Randomized, Double-blind, Placebo-controlled Trial for 6 Months

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: placebo for mitiglinide
* Drug: mitiglinide
* Drug: mitiglinide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type 2 diabetes diagnosed for at least 6 months stable metformin usage for at least 4 months HbA1c 7.5% - 10.5% inclusive no severe diabetic complications Exclusion Criteria: chronic insulin use use of oral diabetic agent within 12 weeks acute or chronic conditions, excluding diabetes, that could compromise end point evaluation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>metformin + placebo for mitiglinide | Drug: placebo for mitiglinide<br>* three times a day with meals<br>|
| Experimental: 2<br>metformin + mitiglinide three times a day with meals | Drug: mitiglinide<br>* three times a day with meals<br>|
| Experimental: 3<br>metformin + mitiglinide two times a day with morning and evening meal, placebo for mitiglinide with midday meal | Drug: mitiglinide<br>* two times a day with meals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in HbA1c |  | after 24 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in 2-hour post-prandial glucose |  | after 24 weeks of treatment | 
| change from baseline in fasting plasma glucose |  | after 24 weeks of treatment |