Official Title: “12-Week, Multicenter, Controlled, Open, 3:1 Randomized, Parallel Clinical Trial Comparing Insulin Glulisine With Regular Human Insulin (Insulin Lispro) Injected Subcutaneously in Subjects With Type 1 or 2 Diabetes Mellitus Also Using Lantus (Insulin Glargine)”

Primary: - To compare the efficacy and safety of Insulin Glulisine to Insulin Lispro in subjects with type 1 or type 2 diabetes mellitus. - To compare the frequency of hypoglycemia of Insulin Glulisine to Insulin Lispro.

Secondary: - To compare Insulin Glulisine to Insulin Lispro in terms of the change in HbA1c at weeks 12, blood glucose parameters, insulin doses and treatment satisfaction in subjects with type 1 or type 2 diabetes mellitus

Study Type: Interventional

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

Study Primary Completion Date: June 2008

Intervention(s) in this Clinical Trial

• Drug: Insulin Glulisine
  • 3 times a day before each meal
• Drug: Lispro
  • 3 times a day before each meal
• Drug: Insulin Glargine
  • once daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Administration of Insulin Glulisine
• Active Comparator: 2
  • Administration of Lispro

Primary Measures

• Hypoglycemic episodes
  • Time Frame: From the beginning to end of the study
    Safety Issue?: No
• Change in HbA1c
  • Time Frame: From baseline to endpoint
    Safety Issue?: No
• Adverse events
  • Time Frame: From the beginning to the end of study
    Safety Issue?: Yes

Secondary Measures

• Change in HbA1c
  • Time Frame: From baseline to weeks 12
    Safety Issue?: No
• blood glucose parameters, hypoglycemic episodes and dosage of the mealtime and Lantus.
  • Time Frame: from baseline to week 12
    Safety Issue?: No

Inclusion Criteria:

• Type 1 or type 2 diabetic patients
• Measure HbA1c 6.5% to 11.0% at visit 1
• More than 3 months of continuous insulin treatment immediately prior to study entry

Exclusion Criteria:

• Pregnant women
• 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 Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Jing Fu Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00467376

Study ID Number: APIDR_L_00348

ClinicalTrials.gov Identifier: NCT00467376

Health Authority: China: State Food and Drug Administration