Gulf, Lantus, Apidra Evaluation in Type 1 Diabetics Study

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: insulin glargine; Drug: insulin glulisine

• Registration Number: NCT00539448
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-10-03
• Study First Submitted QC: 2007-10-03
• Study First Posted: 2007-10-04
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-24
• Last Update Posted: 2009-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	insulin glargine	combination of insulin Glargine \& insulin Glulisine as basal bolus regimen
1	insulin glulisine	combination of insulin Glargine \& insulin Glulisine as basal bolus regimen

Primary Outcome Measures

Name	Time	Method
Evaluating the Glycemic control of the regimen : Change in A1C levels	from baseline to study end

Secondary Outcome Measures

Name	Time	Method
Average daily dose : - For both insulin Glulisine & insulin Glargine. - FBG and PPBG if possible ?	from baseline to study end

Trial Locations

Locations (2)

Sanofi-aventis administrative office; 🇦🇪 Dubai, United Arab Emirates

Sanofi-Aventis Administrative Office; 🇶🇦 Doha, Qatar