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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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A randomized, crossover, open study in order to compare treatment satisfaction with insulin Glargine plus insulin Apidra Vs NPH insulin plus insulin Apidra in newly diagnosed children and adolescents with type 1 diabetes.
The study will include two consecutive periods: 2 weeks run in period and 24 weeks intervention period, divided into two separate treatment periods of 12 weeks. According to randomization, each patient will be treated consecutively with both treatment arms: 12 weeks with insulin Glargine and than 12 weeks with NPH insulin or 12 weeks with insulin NPH ad than 12 weeks with insulin Glargine. Patients will complete DTSQ (Diabetes Treatment Satisfaction Questionnaire) at months 0, 12 and 24 weeks, before and at the end of each study arm.
A randomized, crossover, open study in order to compare treatment satisfaction with insulin Glargine plus insulin Apidra Vs NPH insulin plus insulin Apidra in newly diagnosed children and adolescents with type 1 diabetes.
134 Patients with new onset Diabetes type 1, diagnosed 12 months previously at maximum will be enrolled.
The study will include two consecutive periods: 2 weeks run in period and 24 weeks intervention period, divided into two separate treatment periods of 12 weeks. According to randomization, each patient will be treated consecutively with both treatment arms: 12 weeks with insulin Glargine and than 12 weeks with NPH insulin or 12 weeks with NPH insulin and than 12 weeks with insulin Glargine.
The study will consist of 4 clinical visits, taking place at -2, 0, 12 and 24 weeks. Height,weight,vital signs, HbA1c and insulin doses will be determined during the clinical visits.
Patients will complete DTSQ (Diabetes Treatment Satisfaction Questionnaire) at months 0, 12 and 24 weeks, before and at the end of each study arm.
The DTSQ questionnaires consists of DTSQ parents- for patients below the age of 13, and DTSQ teen for those above age 13.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| insulin Glargine + insulin Apidra | Active Comparator | insulin Glargine + insulin Apidra |
|
| Insulin NPH + Insulin Apidra | Active Comparator | 12 weeks treatment with Insulin NPH + Insulin Apidra |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin Glargine + Insulin Apidra | Drug | 12 wees treatment with Insulin Glargine + Insulin Apidra |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment satisfaction | patients will complete DTSQ at months 0,12 and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | value of Hba1C will be measured at screening visit and at the end of each study arm | |
| 4 and 7 points glucose profile | patients will complete a diary before all clinical visits | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moshe Phillip, Professor | Rabin Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soroka hospital | Bear Sheva | Israel | ||||
| Rambam Hospital |
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| Insulin NPH + Insulin Apidra: Active Comparator | Drug | Insulin NPH + Insulin Apidra: Active Comparator |
|
| Insulin doses |
| Insulin doses will be determined at baseline visit and every visit after |
| Hypoglycemic events | patients will report in their diary every episode of hypoglycemia |
| Haifa |
| Israel |
| Health care unit- Jerusalem | Jerusalem | Israel |
| Schnider children medical center | Petah Tikva | Israel |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| D007336 | Insulin, Isophane |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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