Optimal Oral Hypoglycaemic Agents (OHA) for Combination With Insulin Glargine (Sulfonylurea vs. Metformin)

Study Overview
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Brief Summary
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Primary objective: To find out an optimal regimen of OHA (oral hypoglycaemic agents) in combination with insulin glargine (metformin, glimepiride or metformin+glimepiride) by measuring HbA1c level Secondary objective: To compare the incidence of hypoglycemia in each treatment group

Official Title
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Insulin Glargine Combined With Sulfonylurea Versus Metformin in Patients With Type 2 Diabetes: A Randomized, Controlled Trial.

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Glimepiride
* Drug: Metformin
* Drug: Insulin Glargine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes for at least 6 months Treated with maximal, tolerable dose of metformin (≥ 1000mg/day) and sulfonylurea (glimepiride≥ 4 mg/day or equivalent dose of other SU) for at least 3 months prior to the screening visit 7.0 < HbA1c < 11 % Fasting serum C-peptide > 0.33 nmol/L BMI < 30 kg/m² Patients who is willing to monitor BG using SMBG Exclusion Criteria: Type 1 Diabetes Clinical evidence of active liver disease, or serum ALT 3 times the upper limit of the normal range Serum creatinine: ≥ 1.5 mg/dl for males, ≥ 1.4 mg/dl for females Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (an optic fundus examination should have been performed in the 2 years prior to study entry) History of alcohol or other substance abuse Pregnancy or not using contraceptive in childbearing aged women Breast feeding women History of hypersensitivity to the study drugs or to drugs with a similar chemical structure Treatment with any medication including corticosteroid or herbal medicines that can affect blood glucose level within 3 months prior to study entry except metformin and sulfonylurea. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Administration of 4 mg of Glimepiride with Insulin Glargine | Drug: Glimepiride<br>* Once a day before breakfast<br>Drug: Insulin Glargine<br>* Injection in the morning<br>|
| Active Comparator: 2<br>Administration of 1500 mg of Metformin with Insulin Glargine | Drug: Metformin<br>* After breakfast and supper<br>Drug: Insulin Glargine<br>* Injection in the morning<br>|
| Experimental: 3<br>Administration of a combination of 4mg Glimepiride plus 1000mg Metformin with Insulin Glargine | Drug: Glimepiride<br>* Once a day before breakfast<br>Drug: Metformin<br>* After breakfast and supper<br>Drug: Insulin Glargine<br>* Injection in the morning<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c values |  | At baseline to end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycemia events |  | From inclusion to end of study | 
| Percentage of patients with HbA1c < 7% |  | At the end of the study | 
| Fasting Blood Glucose level |  | At the end of the study |