Study of the Durability of Glycemic Control With Nateglinide

Study Overview
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Brief Summary
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This multi-center, randomized controlled study aims to evaluate the durability and efficacy of nateglinide therapy for long term glycemic control compared with glimepiride.

Detailed Description
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Selected patients will be randomly assigned to receive nateglinide or glimepiride. Previous treatment with oral antidiabetic drugs (metformin, a-glucosidase inhibitor, nateglinide or sulfonylurea) will be discontinued. After a 1 month wash-out period (if 6.5 ≤ HbA1c ≤ 8.5), patients will take randomly assigned drugs for 24 months. Patients will be met by the trial investigator every 3 months following randomization. At each visit, patients whose HbA1c is > 8.0% will be retested 2 weeks later, and if the retested HbA1c is also above 8.0%, those patients will be withdrawn considering monotherapy failure. We will evaluate the durability of nateglinide in comparison with that of glimepiride based on the withdrawal rate.

Official Title
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Multi-center, Randomized, Open Label Study of the Durability of Glycemic Control With Nateglinide Versus Glimepiride as Monotherapy in Type 2 Diabetic Patients

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Nateglinide
* Drug: Glimepiride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type 2 diabetes mellitus age>=18years no anti hyperglycemic agent for 3 months or low-dose oral hypoglycemic therapy metformin≤1g/day, acarbose≤300mg/day, voglibose≤0.9mg/day, nateglinide≤270mg/day, gliclazide≤80mg/day, glimepiride≤2mg/day, glibenclamide≤5mg/day (nateglinide or sulfonylurea <6months) 6.5% ≤ HbA1c ≤ 8.5% patients on no anti hyperglycemic agent for 3 months : HbA1c at screening patients on oral hypoglycemic therapy in 3months : HbA1c after wash-out Exclusion Criteria: attending other clinical trials in 3months type I diabetes mellitus taking systemic steroid in 1month or requiring steroid therapy during clinical trial acute myocardial infarction in 6months alcoholics, pituitary or adrenal insufficiency, severe ketosis, diabetic ketoacidosis severe liver disease or AST, ALT ≥ 2.5 x ULN renal insufficiency (serum creatinine > 2.0mg/dl) other severe diabetic complication drug hypersensitivity history to nateglinide or sulfonylurea pregnant or plan to become pregnant during the clinical trial, lactation

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: Nateglinide<br>Nateglinide 90 120mg three times a day | Drug: Nateglinide<br>* Nateglinide 90 120mg three times a day<br>* Other names: fastic;|
| Active Comparator: Glimepiride<br>Glimepiride 1 2mg once a day | Drug: Glimepiride<br>* Glimepiride 1 2mg once a day<br>* Other names: amaryl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Durability of Nateglinide in Comparison With Those of Glimepiride Based on the Withdrawal Rate | % monotherapy failure, that means % number of participants who withdrew from the study due to high HbA1c (>8.0%) | every 3 months following randomization, for 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | HbA1c (%) at 24 months | at 24 months | 
| Fasting Glucose | fasting glucose (mg/dL) at 24 months | at 24 months | 
| C-peptide | c-peptide(uU/mL) at 24 months | at 24 months | 
| HOMA-IR | insulin resistance marker HOMA-IR at 24 months | at 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, Nateglinide, Pancreatic beta cell function