Glufast On Insulin Glargine Trial in Type 2 DM

Study Overview
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Brief Summary
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We will evaluate the efficacy and safety of combination therapy of 10 mg mitiglinide or 0.2mg voglibose with insulin glargine for 16 weeks after single administration of insulin glargine for 4 weeks in type 2 diabetic patients whose glycemic control were not enough despite administration of oral antidiabetic drug or insulin glargine.

Official Title
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A Prospective, Randomized and Multi-center Clinical Study to Evaluate Efficacy and Safety of Combination Therapy of Mitiglinide or Voglibose With Long-acting Insulin in Type 2 Diabetic Patients

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Mitiglinide
* Drug: Voglibose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The type 2 diabetic patients aged between 30 and 70 The patients whose Hb1Ac is over 7.0% despite administration of two or more oral antidiabetic drugs over 6 months or only insulin glargine over 3 months before registration Outpatients whose BMI is between 21 and 40 kg/㎡ The patients who consented to participate in the clinical study in writing Exclusion Criteria: The patients who have been using insulin formulation except insulin glargine The patients whose fasting blood glucose is over 270 mg/dL The patients whose C-peptide is under 1ng/ml on an empty stomach The patients who was surgically operated of gastrointestinal tract The patients who need additional treatment or who underwent operation within 3 months for severe complication such as diabetic foot ulcer, retinopathy and neuropathy The patients with severe hepatic dysfunction : uncompensated hepatic cirrhosis, or the case where aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is over 2.5 times higher than the normal limit ( ≥ 2.5 x normal ranges) The patients with unstable angina or acute myocardial infarction occurred within 3months The patients with renal failure or severe hypertension : diastolic blood pressure is over 110mmHg despite drug treatment The patients who have a life-threatening disease such as cancer or severe infection The patients with a history of drug allergy Pregnant or breast feeding or the women who are likely to be pregnant The patients who need oral or parenteral corticosteroids The patients who were judged to be unsuitable to the clinical study by other reasons

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: M<br>Mitiglinide | Drug: Mitiglinide<br>* mitiglinide 10mg three times a day before a meal<br>* Other names: Glufast;|
| Active Comparator: V<br>Voglibose | Drug: Voglibose<br>* voglibose 0.2mg three times a day before a meal<br>* Other names: Basen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of HbA1c before and after administration of test drug |  | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of self-monitoring of blood glucose before and after administration of test drug |  | 20 weeks | 
| Change of insulin dose before and after administration of test drug |  | 20 weeks | 
| Achievement rate of HbA1c target level (rate of the patients whose HbA1c were improved under 6.5% after administration) |  | 20 weeks | 
| Change of CRP, 8-OHdG and Nitrotyrosine before and after administration of test drug |  | 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, Type 2, mitiglinide