Test of the Efficacy and Safety of Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus

Study Overview
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Brief Summary
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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

Official Title
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Multicentre, Open, Non-randomised Controlled Phase IV Clinical Trial of Efficacy and Safety for Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus Using Also Insulin Glargine

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: INSULIN GLULISINE (HMR1964)
* Drug: INSULIN GLARGINE


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: APIDRA + LANTUS basal<br>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 | Drug: INSULIN GLULISINE (HMR1964)<br>* 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<br>Drug: INSULIN GLARGINE<br>* Pharmaceutical form: LANTUS 100U/ml solution for injection in cartridge Route of administration: Once daily subcutaneous injection in the evening<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in Glycosylated haemoglobin (HbA1c) |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |