Overview

This trial is active, not recruiting.

Condition diabetes mellitus type 1
Treatments nph insulin, glargine, detemir
Phase phase 4
Sponsor Karolinska Institutet
Start date September 2005
End date March 2011
Trial size 120 participants
Trial identifier NCT01271517, Eudract-number 2005-001726-80

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Treatment twice daily with Insulatard plus Novorapid at meals. Doses adjusted according to bloodsugars
nph insulin
Treatment twice daily with Insulatard plus Novorapid at meals. Doses adjusted according to bloodsugar
(Active Comparator)
Treatment once daily with Levemir plus Novorapid at meals. Doses adjusted according to bloodsugars
glargine
Treatment once daily with Lantus plus Novorapid at meals. Doses adjusted according to bloodsugars
(Active Comparator)
Treatment twice daily with Levemir plus Novorapid at meals. Doses adjusted according to bloodsugars
detemir
Treatment twice daily with Levemir plus Novorapid at meals. Doses adjusted according to bloodsugars

Primary Outcomes

Measure
HbA1c
time frame: 1 year

Secondary Outcomes

Measure
Stimulated C-peptide
time frame: 2 weeks and 3, 6 and 12 month
IGF-I
time frame: diagnosis, 2 weeks, 3,6,9 and 12 month

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in January 2011.
Information provided to ClinicalTrials.gov by Karolinska Institutet.