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

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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2008

Intervention(s) in this Clinical Trial

• Drug: Insulin Glargine
  • Throughout study period
• Drug: Glyburide
  • Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
• Drug: Glyclazide
  • Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
• Drug: Glimiperide
  • Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
• Drug: Glipizide
  • Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
• Drug: Metformin
  • Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Administration of Insulin Glargine and Sulfonylurea or Metformin
• Active Comparator: 2
  • Administration of Sulfonylurea or Metformin + a second Oral Anti Diabetic (OAD) among Glyburide, Glyclazide,Glimiperide,Glipizide or Metformin

Primary Measures

• A1c values
  • Time Frame: At baseline and 24 weeks
    Safety Issue?: No

Secondary Measures

• Adverse events including hypoglycemia
  • Time Frame: From the beginning to the end of the study
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Bruno Jolain Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00347100

Study ID Number: LANTU_L_01051

ClinicalTrials.gov Identifier: NCT00347100

Health Authority: China: State Food and Drug Administration