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: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska Institutet
• Treatments: Insulin; Insulin Aspart; Insulin Detemir; Insulin Glargine; Insulin, Globin Zinc; Insulin, Isophane; Isophane insulin, beef; Isophane Insulin, Human

Criteria

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