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

Karolinska Institute

Status and phase: Unknown; Phase 4

Conditions: Diabetes Mellitus Type 1

Treatments: Drug: Glargine; Drug: NPH insulin; Drug: Detemir

Study type: Interventional

Funder types: Other

Identifiers

NCT01271517

Eudract-number 2005-001726-80

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Insulatard

Active Comparator group

Description:

Treatment twice daily with Insulatard plus Novorapid at meals. Doses adjusted according to bloodsugars

Treatment:

Drug: NPH insulin

Lantus

Active Comparator group

Description:

Treatment once daily with Levemir plus Novorapid at meals. Doses adjusted according to bloodsugars

Treatment:

Drug: Glargine

Levemir

Active Comparator group

Description:

Treatment twice daily with Levemir plus Novorapid at meals. Doses adjusted according to bloodsugars

Treatment:

Drug: Detemir