Insulin Glulisine in Type 2 Diabetic Patients

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Glimepiride; Insulin; Insulin Glargine; Insulin glulisine; Insulin, Globin Zinc; Metformin

Criteria

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.