Insulin Glargine in Type 2 Diabetic Patients

Study Overview
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Brief Summary
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Primary: To investigate the efficacy of insulin glargine (in terms of change in A1c from baseline to endpoint A1c < 7%) Secondary: To investigate the safety of insulin glargine (in terms of hypoglycaemia, including symptomatic, non-symptomatic and nocturnal hypoglycaemia) To investigate whether beta cell function is preserved if this therapy is initiated before 2nd OAD (oral anti-diabetic drug) failure

Official Title
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Treatment of Early Insulinization With Glargine in Type 2 Diabetes Patients Uncontrolled on Sulfonylurea or Metformin Monotherapy

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Insulin Glargine
* Drug: Glyburide
* Drug: Glyclazide
* Drug: Glimiperide
* Drug: Glipizide
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes patients with first OAD (Sulfonylurea [SU] or Metformin) failure Patients who are insulin naive (unless it was used for gestational diabetes or if insulin therapy was less than 1 week) Serum creatinine ≤ 1.5mg/dL BMI: 21-41 kg/m² 7.5%< A1c <11% Fasting plasma glucose > 7.5mmol/L On diet and exercise therapy and stable OAD treatment (SU or metformin > ½ maximal dose)for more than 1 month prior to enrolment Women not of childbearing potential (sterilization procedure done or menopausal > 2 years), or if of childbearing potential, agree to take reliable contraceptive measures during the study Able and willing to monitor blood glucose Able and willing to perform 7 point blood glucose self monitoring at baseline, 12 week and 24 week Understand that there is a 50% chance of being randomized to the insulin treatment arm and is willing to self inject insulin Exclusion Criteria: Type 1 diabetes Acute complication of diabetes, such as diabetic ketoacidosis and hyperosmolar coma Pregnancy, breast-feeding People who work night shifts Hypersensitivity to investigational drugs or its additives, or intolerability to metformin Need for use of medications prohibited by the protocol during the study for treatment purpose Significant diseases in cardiovascular, liver, nerve, endocrine or other systems, unable to complete the study or difficult to be used in study analysis Drugs or alcohol abuse 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: 80 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: 1<br>Administration of Insulin Glargine and Sulfonylurea or Metformin | Drug: Insulin Glargine<br>* Throughout study period<br>Drug: Metformin<br>* Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.<br>|
| Active Comparator: 2<br>Administration of Sulfonylurea or Metformin + a second Oral Anti Diabetic (OAD) among Glyburide, Glyclazide,Glimiperide,Glipizide or Metformin | Drug: Glyburide<br>* Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.<br>Drug: Glyclazide<br>* Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.<br>Drug: Glimiperide<br>* Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.<br>Drug: Glipizide<br>* Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.<br>Drug: Metformin<br>* Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A1c values |  | At baseline and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events including hypoglycemia |  | From the beginning to the end of the study |