Test of the Efficacy and Safety of Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus
NCT ID: NCT00964574
Last Updated: 2012-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
68 participants
INTERVENTIONAL
2009-07-31
2010-07-31
Brief Summary
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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 patient satisfaction
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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APIDRA + LANTUS basal
The 2 first weeks, patients will receive subcutaneous injection of Insulin Glulisine and Insulin Glargine once daily in hospital. The rest of the treatement is to be take at home until week 12
INSULIN GLULISINE (HMR1964)
Pharmaceutical form:
APIDRA 100U/ml flacon for the titration period in the hospital APIDRA 100U/ml solution for injection in cartridge in OptiSet
Route of administration:
3-4 subcutaneous injections per day
INSULIN GLARGINE
Pharmaceutical form:
LANTUS 100U/ml solution for injection in cartridge
Route of administration:
Once daily subcutaneous injection in the evening
Interventions
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INSULIN GLULISINE (HMR1964)
Pharmaceutical form:
APIDRA 100U/ml flacon for the titration period in the hospital APIDRA 100U/ml solution for injection in cartridge in OptiSet
Route of administration:
3-4 subcutaneous injections per day
INSULIN GLARGINE
Pharmaceutical form:
LANTUS 100U/ml solution for injection in cartridge
Route of administration:
Once daily subcutaneous injection in the evening
Eligibility Criteria
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Inclusion Criteria
* 6.5 \<=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
* 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Natallia Zhyhaila
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Minsk, , Belarus
Countries
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Other Identifiers
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APIDR_L_02483
Identifier Type: -
Identifier Source: org_study_id