Gulf, Lantus, Apidra Evaluation in Type 1 Diabetics Study

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary objective :

To evaluate the efficacy (in terms of change in HbA1c readings starting from baseline then after 13 weeks & at the end of the study which will be after 26 weeks) in subjects with type I diabetes mellitus.

Secondary objective :

• Recording the average daily dose of both insulin Glulisine & insulin Glargine in type I DM.

• Recording adverse events.

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

Details

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

Criteria

Inclusion Criteria:

• Newly diagnosed type I diabetic patients

• Type I diabetes treated with basal-bolus regimen including 3 or more injections of Regular Human Insulin per day

• BMI, 26-40 kg/m2

• HbA1c, 7.5%-10%

• Median 2Hrs post -prandial more than or equal to 140 mg/dl (more than or equal to 7.8 mmol/L)

• FPG more than or equal to 120 mg/dl (more than or equal to 6.7 mmol/L)

• Willingness to accept, and ability to inject insulin Glargine therapy

Exclusion Criteria:

• Pregnancy : The use of LANTUS & APIDRA during pregnancy is not contraindicated. However, in the absence of supportive data, Sanofi- Aventis Pharmaceuticals cannot specifically recommend the use of Lantus in this patient population

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