Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1116-8645 | Other Identifier | UTN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Primary Objective:
Evaluate the percentage of patients achieving glycosylated hemoglobin (HbA1c) level < 8% (in patients of 6-12 years old) and HbA1c level < 7.5% (in patients of 13-17 year old) at 6 and 12 months of treatment
Secondary Objectives:
Change in HbA1c level at 6 and 12 months of treatment Monthly rate of hypoglycaemia/per patient from the baseline to the end of the study Change in daily dose of glargine and glulisine at 6 and 12 months of treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| insulin glulisine and insulin glargine | Experimental | insulin glulisine and insulin glargine basal/bolus regimen in accordance with the summary of product characteristics and titrated to Plasma glucose target as defined by American Diabetes Association (ADA) recommendations age-specific goals (12) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INSULIN GLULISINE | Drug | Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients achieving HbA1c level < 8% (in patients 6-12 year-old) and HbA1c level < 7.5 % (in patients 13-17 year-old) | at 6 and 12 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c plasma level | at 6 and 12 months of treatment | |
| Monthly rate of hypoglycaemia | from baseline to 12 months of treatment (study cut off) | |
| Change in daily dose of glargine and glulisine |
Not provided
Inclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Administrative office | Moscow | Russia |
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C479079 | insulin glulisine |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| INSULIN GLARGINE | Drug | Pharmaceutical form:solution for injection Route of administration: subcutaneous Dose regimen: 0-15 minutes before meal or within 20 minutes from the start of meal according to prandial plasma glucose values |
|
|
| at 6 and 12 months of treatment |
| 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 |