Insulin Glulisine in Type 2 Diabetic Patients

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Other: insulin glulisine+insulin glargine+metformin+glimepiride
  • Bolus arm
• Other: insulin glargine+metformin+glimepiride
  • Control arm

Primary Measures

• Patients With Glycosylated Haemoglobin (HbA1c) Value < 7%
  • Time Frame: at the end of treatment (week 24)
    Safety Issue?: No

Secondary Measures

• Glycosylated Haemoglobin (HbA1c) Value
  • Time Frame: at the end of treatment (week 24)
    Safety Issue?: No
• Change in Glycosylated Haemoglobin (HbA1c) Value
  • Time Frame: from baseline to the end of treatment (week 24)
    Safety Issue?: No
• Daily Mean Plasma Glucose
  • Time Frame: at the end of treatment (week 24)
    Safety Issue?: No
• Change in Daily Mean Plasma Glucose
  • Time Frame: from baseline to the end of treatment (week 24)
    Safety Issue?: No
• Change in Weight
  • Time Frame: from baseline to the end of treatment (week 24)
    Safety Issue?: No
• Daily Dose of Insulin Glargine
  • Time Frame: at the end of treatment (week 24)
    Safety Issue?: No
• Daily Dose of Insulin Glulisine
  • Time Frame: at the end of treatment (week 24)
    Safety Issue?: No
• Rate of Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL
  • Time Frame: during treatment period (12 weeks)
    Safety Issue?: No
• Rate of Nocturnal Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL
  • Time Frame: during treatment period (12 weeks)
    Safety Issue?: No
• Rate of Severe Symptomatic Hypoglycemia
  • Time Frame: during treatment period (12 weeks)
    Safety Issue?: No

Inclusion Criteria:

• Diabetes Mellitus, Type 2
• 25 < BMI < 45 kg/m²
• 7,5% < HbA1c < 9%
• Treated with a 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, with exenatide or with pramlintide
• 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 Investigator: Sanofi-Aventis Industry

Overall Clinical Trial Officials and Contacts

PILORGET Valérie, MD Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on February 12, 2012

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