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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Treatment twice daily with Insulatard plus Novorapid at meals. Doses adjusted according to bloodsugar
Treatment once daily with Lantus plus Novorapid at meals. Doses adjusted according to bloodsugars
Treatment twice daily with Levemir plus Novorapid at meals. Doses adjusted according to bloodsugars
Division of Pediatrics, Karolinska University Hospital
Stockholm, Sweden
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.
Time frame: 1 year
Stimulated C-peptide
Sustacal stimulated C-peptide after an overnight fast
Time frame: 2 weeks and 3, 6 and 12 month
IGF-I
Serum IGF-I concentrations
Time frame: diagnosis, 2 weeks, 3,6,9 and 12 month
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