Official Title: “Comparison of Two Therapeutic Strategies for Treating Type 2 Diabetic Patients Poorly Controlled With Basal Insulin Associated With Oral Antidiabetic Drugs : 6-Month Proof of Concept Study.”

To evaluate the efficacy of a single injection of glulisine before the main meal added to insulin glargine plus oral antidiabetic drugs (OADs) compared to insulin glargine plus OADs in Type 2 diabetic patients poorly controlled with basal insulin plus OADs.

Study Type: Interventional

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

Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

• Drug: Insulin Glargine
  • One daily injection in the evening
• Drug: Glimepiride
  • At same dosages as during the run-in period
• Drug: Insulin Glulisine
  • One bolus given before the main meal
• Drug: Metformin
  • At same dosages as during the run-in period

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • insulin glargine + metformin + glimepiride
• Active Comparator: 2
  • Insulin glulisine + insulin glargine + metformin + glimepiride

Primary Measures

• Percentage of patients with HbA1c level < 7%.
  • Time Frame: At the end of treatment period
    Safety Issue?: No

Secondary Measures

• Variation in the HbA1c level
  • Time Frame: Between randomization visit (V10) and the end of treatment period
    Safety Issue?: No
• Blood glucose levels
  • Time Frame: Before and 2 hours after each meal and at bedtime, at randomization visit / V10, V14, V16, and V18
    Safety Issue?: No
• Treatment emergent adverse events.
  • Time Frame: During the treatment period
    Safety Issue?: Yes
• Safety : Hypoglycemia
  • Time Frame: At the run-in period and the treatment period
    Safety Issue?: No
• Vital signs: variation
  • Time Frame: Between the value at randomization (V10) and the last value on treatment
    Safety Issue?: No

Inclusion Criteria:

• Diabetes Mellitus, Type 2
• 25 < BMI < 45 kg/m²
• 7,5% < HbA1c < 9%
• Treated with a single injection of basal insulin (NPH, Insulin Zinc, Insulin glargine or Insulin detemir), and at least 1g metformin daily, for more than 3 months

Exclusion Criteria:

• Type 1 diabetes mellitus
• Treatment with OADs only
• Treatment with thiazolidinediones
• Treatment with an insulin other than basal insulin (Premix, rapid insulin, fast-acting insulin analogue)
• Active proliferative diabetic retinopathy,
• Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and effective contraception)
• Breast-feeding
• History of hypersensitivity to the study drugs or to drugs with a similar chemical structure.
• Treatment with systemic corticosteroids in the 3 months prior to study entry
• Treatment with any investigational product in the 2 months prior to study entry
• Previous treatment with insulin glulisine
• Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
• Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
• Impaired hepatic function
• Impaired renal function
• History of drug 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: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

PILORGET Valérie, MD Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00360698

Study ID Number: HMR1964A_4002

ClinicalTrials.gov Identifier: NCT00360698

Health Authority: United States: Institutional Review Board