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Hypothesis: Basal insulin analogs with continuous 24-hour delivery of insulin improve glycemic control during the first year of treatment of children/adolescents with type 1 diabetes mellitus (T1DM)by preserving endogenous insulin production and a close to normal balance of the GH-IGF-axis.
This a randomized, open-label, parallel-group trial of 120 children, 7 - 17 years of age, newly diagnosed with T1DM. The investigators will investigate whether the use of long-acting basal insulin analogs Lantus (Glargine) or Levemir (Detemir) during the first year of treatment results in improved glycemic control (HbA1c) compared with Insulatard (NPH insulin) when given in a meal insulin therapy regimen with rapid acting Novorapid (insulin aspart). The investigators will explore possible mechanisms of action by determining remaining endogenous insulin production and changes in the GH-IGF-axis. The investigators will also assess changes in body composition and evaluate quality of life in each treatment arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulatard | Active Comparator | Treatment twice daily with Insulatard plus Novorapid at meals. Doses adjusted according to bloodsugars |
|
| Lantus | Active Comparator | Treatment once daily with Levemir plus Novorapid at meals. Doses adjusted according to bloodsugars |
|
| Levemir | Active Comparator | Treatment twice daily with Levemir plus Novorapid at meals. Doses adjusted according to bloodsugars |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPH insulin | Drug | Treatment twice daily with Insulatard plus Novorapid at meals. Doses adjusted according to bloodsugar |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | The study compare HbA1c one year after start of treatment at diagnosis of T1DM in patients treated with Lantus or Levemir with patients treated with Insulatard. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Stimulated C-peptide | Sustacal stimulated C-peptide after an overnight fast | 2 weeks and 3, 6 and 12 month |
| IGF-I | Serum IGF-I concentrations |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Pediatrics, Karolinska University Hospital | Stockholm | 17176 | Sweden |
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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 |
|---|---|
| D007336 | Insulin, Isophane |
| D000069036 | Insulin Glargine |
| D000069057 | Insulin Detemir |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Glargine | Drug | Treatment once daily with Lantus plus Novorapid at meals. Doses adjusted according to bloodsugars |
|
| Detemir | Drug | Treatment twice daily with Levemir plus Novorapid at meals. Doses adjusted according to bloodsugars |
|
| diagnosis, 2 weeks, 3,6,9 and 12 month |
| 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 |