Test of the Efficacy and Safety of Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

To evaluate the efficacy and the safety of insulin glulisine in type I Diabetes Melittus (DM) patients

Secondary Objective:

To evaluate the insulin glulisine doses To assess the patient satisfaction

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

Details

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

Criteria

Inclusion Criteria:

• Patients with type 1 diabetes mellitus who need insulin basal+ bolus regimen

• 6.5 <=HbA1c <= 11% at visit 1

• BMI <35 kg/m²

• Provision of signed and dated informed consent prior to any study procedures

• Ability and willingness to complete study diaries and questionnaires

• Demonstrated ability to use the self-glucose-monitoring device, and to self-inject insulin

• A negative pregnancy test for all females of childbearing potential.

Exclusion criteria:

• Hypersensitivity to insulin Glulisine, insulin Glargine or one of their excipients

• Pregnant women

• Active proliferative diabetic retinopathy

• Impaired hepatic or renal function

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.