Gulf, Lantus, Apidra Evaluation in Type 1 Diabetics Study
Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 1
Intervention: insulin glargine (Drug); insulin glulisine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Sanofi Official(s) and/or principal investigator(s): Hisham - MAHMOUD, MD, Study Director, Affiliation: Sanofi
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.
Clinical Details
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.
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Evaluating the Glycemic control of the regimen : Change in A1C levels
Secondary outcome: Average daily dose : - For both insulin Glulisine & insulin Glargine. - FBG and PPBG if possible ?
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
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
Locations and Contacts
Sanofi-aventis administrative office, Manama, Bahrain
Sanofi-aventis administrative office, Kuwait City, Kuwait
Sanofi-Aventis Administrative Office, Doha, Qatar
Sanofi-aventis administrative office, Dubai, United Arab Emirates
Additional Information
Starting date: April 2007
Last updated: September 24, 2009
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