Basal Analog Study - Comparison of Lantus or Levemir With NPH Insulin From T1DM Diagnosis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes Mellitus Type 1

Intervention / Treatment
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* Drug: NPH insulin
* Drug: Glargine
* Drug: Detemir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Insulatard<br>Treatment twice daily with Insulatard plus Novorapid at meals. Doses adjusted according to bloodsugars | Drug: NPH insulin<br>* Treatment twice daily with Insulatard plus Novorapid at meals. Doses adjusted according to bloodsugar<br>|
| Active Comparator: Lantus<br>Treatment once daily with Levemir plus Novorapid at meals. Doses adjusted according to bloodsugars | Drug: Glargine<br>* Treatment once daily with Lantus plus Novorapid at meals. Doses adjusted according to bloodsugars<br>|
| Active Comparator: Levemir<br>Treatment twice daily with Levemir plus Novorapid at meals. Doses adjusted according to bloodsugars | Drug: Detemir<br>* Treatment twice daily with Levemir plus Novorapid at meals. Doses adjusted according to bloodsugars<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | diagnosis, 2 weeks, 3,6,9 and 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Basal insulin, long acting insulin analogs, metabolic control, HbA1c, C-peptide, IGF-I, GH, IGFBP