- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00539448
Gulf, Lantus, Apidra Evaluation in Type 1 Diabetics Study (GLANS)
September 24, 2009 updated by: Sanofi
Phase IV, Open Label, Non-comparative, Multi-center, Study of the Effects of Both Insulin Glargine & Insulin Glulisine in Type I Diabetes Mellitus Patients.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
98
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Manama, Bahrain
- Sanofi-Aventis Administrative Office
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Kuwait City, Kuwait
- Sanofi-Aventis Administrative Office
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Doha, Qatar
- Sanofi-Aventis Administrative Office
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Dubai, United Arab Emirates
- Sanofi-Aventis Administrative Office
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
combination of insulin Glargine & insulin Glulisine as basal bolus regimen
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in combination with insulin Glulisine as bolus regimen
in combination with insulin Glargine as bolus regimen
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Evaluating the Glycemic control of the regimen : Change in A1C levels
Time Frame: from baseline to study end
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from baseline to study end
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Average daily dose : - For both insulin Glulisine & insulin Glargine. - FBG and PPBG if possible ?
Time Frame: from baseline to study end
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from baseline to study end
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Hisham - MAHMOUD, MD, Sanofi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
October 3, 2007
First Submitted That Met QC Criteria
October 3, 2007
First Posted (Estimate)
October 4, 2007
Study Record Updates
Last Update Posted (Estimate)
September 25, 2009
Last Update Submitted That Met QC Criteria
September 24, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LANTU_L_01578
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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