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

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Glimepiride; Insulin; Insulin Glargine; Metformin

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.