Basal Analog Study - Comparison of Lantus or Levemir With NPH Insulin From T1DM Diagnosis
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
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.