Overview

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.