Insulin Glulisine in Type 2 Diabetic Patients

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: Insulin Glargine (Drug); Glimepiride (Drug); Insulin Glulisine (Drug); Metformin (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Sanofi-Aventis

Official(s) and/or principal investigator(s):
PILORGET Valérie, MD, Study Director, Affiliation: Sanofi-Aventis

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.

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.

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

Primary outcome: Percentage of patients with HbA1c level < 7%.

Secondary outcome:

Variation in the HbA1c level

Blood glucose levels

Treatment emergent adverse events.

Safety : Hypoglycemia

Vital signs: variation

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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.

Sanofi-Aventis, Moscow, Russian Federation

Sanofi-aventis, Guildford, United Kingdom

Sanofi-aventis, Bridgewater, New Jersey 08807, United States

Starting date: July 2006
Last updated: May 27, 2008