Status:
COMPLETED
Test of the Efficacy and Safety of Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Primary Objective: To evaluate the efficacy and the safety of insulin glulisine in type I Diabetes Melittus (DM) patients Secondary Objective: To evaluate the insulin glulisine doses To assess the ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients with type 1 diabetes mellitus who need insulin basal+ bolus regimen
- 5 \<=HbA1c \<= 11% at visit 1
- BMI \<35 kg/m²
- Provision of signed and dated informed consent prior to any study procedures
- Ability and willingness to complete study diaries and questionnaires
- Demonstrated ability to use the self-glucose-monitoring device, and to self-inject insulin
- A negative pregnancy test for all females of childbearing potential.
- Exclusion criteria:
- Hypersensitivity to insulin Glulisine, insulin Glargine or one of their excipients
- Pregnant women
- Active proliferative diabetic retinopathy
- Impaired hepatic or renal function
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00964574
Start Date
July 1 2009
End Date
July 1 2010
Last Update
July 17 2012
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Minsk, Belarus