Diabetes Mellitus, Type 1
Conditions
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 patient satisfaction
Interventions
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
DRUGINSULIN GLARGINE
Pharmaceutical form: LANTUS 100U/ml solution for injection in cartridge Route of administration: Once daily subcutaneous injection in the evening
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with type 1 diabetes mellitus who need insulin basal+ bolus regimen * 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
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in Glycosylated haemoglobin (HbA1c) | Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Mean Glycosylated haemoglobin (HbA1c) | Week 12 |
| Mean Fasting Blood Glucose and mean Post Prandial Glycemia | Week 12 |
| Number of documented symptomatic hypoglycaemic episodes | From week 0 to week 12 |
| Mean dose and mean dose change of insulin glulisine, basal glulisine and total insulin from baseline | week 12 |
| Mean change of Fasting Blood Glucose and Post Prandial Glycemia | From week 0 to week 12 |
Countries
Belarus
Outcome results
None listed