Basal Analog Study - Comparison of Lantus or Levemir With NPH Insulin From T1DM Diagnosis
This trial is active, not recruiting.
|Condition||diabetes mellitus type 1|
|Treatments||nph insulin, glargine, detemir|
|Start date||September 2005|
|End date||March 2011|
|Trial size||120 participants|
|Trial identifier||NCT01271517, Eudract-number 2005-001726-80|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
time frame: 1 year
time frame: 2 weeks and 3, 6 and 12 month
time frame: diagnosis, 2 weeks, 3,6,9 and 12 month
Male or female participants from 7 years up to 17 years old.
Inclusion Criteria: - Diagnosis of diabetes and novel to insulin therapy - Age 7 - 17 years - Informed consent Exclusion Criteria: - Moderate to severe ketoacidosis (pH<7.2 and/or standard bicarbonate <10 mmol/l) - Suspected non-type 1 - IA2 and GAD65: all-antibody negative - Celiac disease or other chronic disease - Hypothyroidism, if not well controlled - Syndromes - Previous anorexia nervosa - Neuro-psychiatric disease - Malignancy
|Official title||Effects of New Longacting Insulin Analogs on Metabolic Control, Endogenous Insulin Production, GH/IGF-I Axis and Quality of Life - Comparison of NPH, Glargine Och Detemir Insulin From the Debut of Type 1 Diabetes Mellitus in Adolescents|
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