Efficacy of Repaglinide in Subjects With Type 2 Diabetes

Study Overview
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Brief Summary
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This trial is conducted in Europe. The aim of this trial is to compare the efficacy of repaglinide to glyburide and placebo on hepatic glucose metabolism in subjects with type 2 diabetes.

Official Title
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Efficacy of Repaglinide Compared to Glyburide and Placebo on Hepatic Glucose Metabolism in Type 2 Diabetic Subjects Treated With Diet or With Antidiabetic Oral Agents. A Randomized, Open, Cross-over Single-centre Placebo-controlled Trial

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: repaglinide
* Drug: glyburide
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes HbA1c (glycosylated haemoglobin A1c) above 7 % BMI (body mass index) below 32 kg/m^2 FBG (fasting blood glucose) after wash out period 130-220 mg/dl Currently treated with diet or OHA (oral hypoglycaemic agent) Exclusion Criteria: Current systemic treatment with concomitant medication Known or suspected history of drug or alcohol dependence Any other significant concomitant disease such as cerebrovascular or symptomatic peripheral vascular disease, malignant, disease or severe treated or untreated hypertension Hepatic disease Cardiac problems Active proliferative retinopathy Known or suspected allergy to trial product or related products Women in fertile age and women having the intention of becoming pregnant Body Mass Index (BMI) above 32 kg/m^2

Ages Eligible for Study
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Minimum Age: 40 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment period 1<br> | Drug: repaglinide<br>* 1 mg before each main meal on three separate dosing visits separated by a wash-out period<br>Drug: glyburide<br>* 5 mg before breakfast and before supper on three separate dosing visits separated by a wash-out period<br>Drug: placebo<br>* Before each main meal on three separate dosing visits separated by a wash-out period<br>|
| Active Comparator: Treatment period 2<br> | Drug: repaglinide<br>* 1 mg before each main meal on three separate dosing visits separated by a wash-out period<br>Drug: glyburide<br>* 5 mg before breakfast and before supper on three separate dosing visits separated by a wash-out period<br>Drug: placebo<br>* Before each main meal on three separate dosing visits separated by a wash-out period<br>|
| Placebo Comparator: Treatment period 3<br> | Drug: repaglinide<br>* 1 mg before each main meal on three separate dosing visits separated by a wash-out period<br>Drug: glyburide<br>* 5 mg before breakfast and before supper on three separate dosing visits separated by a wash-out period<br>Drug: placebo<br>* Before each main meal on three separate dosing visits separated by a wash-out period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Basal hepatic glucose production |  | Day 0; day 44 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hypoglycaemic episodes |  | Day 0; day 44 | 
| Change in body weight |  | Day 0; day 44 | 
| Number of adverse events |  | Day 0; day 44 |