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To evaluate the efficacy (in terms of change HbA1c from baseline to endpoint) and safety (in terms of adverse events, clinical chemistry, lipids, hematology) of insulin glulisine (HMR 1964) in subjects with type I diabetes mellitus To evaluate the change in HbA1c at week 26, blood/glucose parameters, hypoglycemia, insulin dose in subjects with type I diabetes mellitus receiving HMR 1964 and insulin glargine.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insuline Glulisine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change of HbA1c. | from baseline to endpoint. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c. | from baseline (week 1) to weeks 12 and 26 | |
| Blood glucose parameters, hypoglycaemic episodes and dosage of the mealtime and basal insulins. | from baseline to endpoint. |
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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 |
|---|---|---|
| Olga Efremenkova | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-aventis | Moscow | Russia |
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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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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |