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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APIDRA + LANTUS basal | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INSULIN GLULISINE (HMR1964) | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in Glycosylated haemoglobin (HbA1c) | Week 12 |
| 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 |
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Inclusion Criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Natallia Zhyhaila | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Minsk | Belarus |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C479079 | insulin glulisine |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| INSULIN GLARGINE | Drug | Pharmaceutical form: LANTUS 100U/ml solution for injection in cartridge Route of administration: Once daily subcutaneous injection in the evening |
|
| 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 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |