Insulin Glargine (Lantus) vs Sulfonylurea (SU) for BETA Cell Function (BETA Study)

Study Overview
=================
Brief Summary
-----------------
Primary objective: To compare long-term glycemic control and preservation of beta cell function when basal insulin or sulfonylurea is added on metformin in the early Type 2 Diabetes Mellitus patients Secondary objective: To assess the change of insulin resistance, microvascular complication incidence, patient satisfaction with treatment

Official Title
-----------------
Lantus vs Sulfonylurea as add-on Therapy in Type 2 Diabetic Patients Failing Metformin Monotherapy: Comparison of Effects on Beta Cell Function and Metabolic Profile.

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Insulin glargine
* Drug: Glimepiride
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
List of Inclusion and Exclusion Criteria: Inclusion Criteria: Type 2 Diabetes Mellitus patients on metformin monotherapy 7% ≤ HbA1c ≤ 12% 20 kg/m² ≤BMI ≤ 35 kg/m² Diabetes duration: at least 6 months Exclusion Criteria: Type 1 Diabetes Mellitus patients Clinical evidence of active liver disease, or serum Alanine AminoTransferase 3 times the upper limit of the normal range Serum creatinine: 1.5 mg/dl for males, 1.4 mg/dl for females Acute and chronic metabolic acidosis, including diabetic ketoacidosis History of alcohol or other substance abuse Pregnancy or not using contraceptive in childbearing aged women Known hypersensitivity to Lantus, SU or metformin Any disease or condition that in the opinion of the investigator may interfere with completion of the study 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
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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> | Drug: Insulin glargine<br>* Once daily in the morning<br>Drug: Metformin<br>* At least 1000 mg/day<br>|
| Active Comparator: 2<br> | Drug: Glimepiride<br>* Once daily in the morning<br>Drug: Metformin<br>* At least 1000 mg/day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ß-cell Function parameter |  | From the signature of the Informed Consent Form (ICF) up to the end of study | 
| Glucose Homeostasis and glycemic control status |  | From the signature of the Informed Consent Form (ICF) up to the end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin resistance parameter, Hypoglycemic episode, symptomatic, Weight change, Lipid profile, Inflammatory markers (CRP, Adiponectin, etcs), Patient satisfaction with diabetes treatment, Urine analysis, Creatinine |  | End of the study |