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

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.”

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

Intervention(s) in this Clinical Trial

• Drug: Insulin glargine
  • Once daily in the morning
• Drug: Glimepiride
  • Once daily in the morning
• Drug: Metformin
  • At least 1000 mg/day

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• ß-cell Function parameter
  • Time Frame: From the signature of the Informed Consent Form (ICF) up to the end of study
    Safety Issue?: No
• Glucose Homeostasis and glycemic control status
  • Time Frame: From the signature of the Informed Consent Form (ICF) up to the end of study
    Safety Issue?: No

Secondary Measures

• Insulin resistance parameter, Hypoglycemic episode, symptomatic, Weight change, Lipid profile, Inflammatory markers (CRP, Adiponectin, etcs), Patient satisfaction with diabetes treatment, Urine analysis, Creatinine
  • Time Frame: End of the study
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Sanofi-Aventis Industry

Overall Clinical Trial Officials and Contacts

Ji Young Ahn Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00562172

Study ID Number: LANTU_L_02193

ClinicalTrials.gov Identifier: NCT00562172

Health Authority: Korea: Institutional Review Board of Severance Hospital