Phase IV, Open Label, Non-comparative, Multi-center, Study of the Effects of Both Insulin Glargine & Insulin Glulisine in Type I Diabetes Mellitus Patients.

Sanofi2 sites in 2 countries98 target enrollmentApril 2007

ConditionsDiabetes Mellitus, Type 1

Interventionsinsulin glulisine insulin glargine

Drugsinsulin glargine insulin glulisine

Overview

Phase: Phase 4
Intervention: insulin glulisine
Conditions: Diabetes Mellitus, Type 1
Sponsor: Sanofi
Enrollment: 98
Locations: 2
Primary Endpoint: Evaluating the Glycemic control of the regimen : Change in A1C levels
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 2007

End Date

December 2008

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sanofi

Eligibility 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