Gulf, Lantus, Apidra Evaluation in Type 1 Diabetics Study

Diabetes Mellitus, Type 1 Clinical Trial

— GLANS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00539448
• Other study ID #: LANTU_L_01578
• Status: Completed
• Phase: Phase 4
• First received: October 3, 2007
• Last updated: September 24, 2009
• Start date: April 2007
• Est. completion date: December 2008

Study information

• Verified date: September 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Arab Emirates: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin glargine
in combination with insulin Glulisine as bolus regimen
• insulin glulisine
in combination with insulin Glargine as bolus regimen

Locations

Country	Name	City	State
Bahrain	Sanofi-aventis administrative office	Manama
Kuwait	Sanofi-aventis administrative office	Kuwait City
Qatar	Sanofi-Aventis Administrative Office	Doha
United Arab Emirates	Sanofi-aventis administrative office	Dubai

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Bahrain,  Kuwait,  Qatar,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluating the Glycemic control of the regimen : Change in A1C levels		from baseline to study end	No
Secondary	Average daily dose : - For both insulin Glulisine & insulin Glargine. - FBG and PPBG if possible ?		from baseline to study end	No