Insulin Glulisine, Insulin Lispro and Insulin Glargine in Type 1 or 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Primary:

• To compare the efficacy and safety of Insulin Glulisine to Insulin Lispro in subjects with type 1 or type 2 diabetes mellitus.

• To compare the frequency of hypoglycemia of Insulin Glulisine to Insulin Lispro.

Secondary:

• To compare Insulin Glulisine to Insulin Lispro in terms of the change in HbA1c at weeks 12, blood glucose parameters, insulin doses and treatment satisfaction in subjects with type 1 or type 2 diabetes mellitus

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Type 1 or type 2 diabetic patients

• Measure HbA1c 6.5% to 11.0% at visit 1

• More than 3 months of continuous insulin treatment immediately prior to study entry

Exclusion Criteria:

• Pregnant women

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