Basal Analog Study - Comparison of Lantus or Levemir With NPH Insulin From T1DM Diagnosis
- Registration Number
- NCT01271517
- Lead Sponsor
- Karolinska Institutet
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- Diagnosis of diabetes and novel to insulin therapy
- Age 7 - 17 years
- Informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Insulatard NPH insulin Treatment twice daily with Insulatard plus Novorapid at meals. Doses adjusted according to bloodsugars Lantus Glargine Treatment once daily with Levemir plus Novorapid at meals. Doses adjusted according to bloodsugars Levemir Detemir Treatment twice daily with Levemir plus Novorapid at meals. Doses adjusted according to bloodsugars
- Primary Outcome Measures
Name Time Method HbA1c 1 year 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.
- Secondary Outcome Measures
Name Time Method Stimulated C-peptide 2 weeks and 3, 6 and 12 month Sustacal stimulated C-peptide after an overnight fast
IGF-I diagnosis, 2 weeks, 3,6,9 and 12 month Serum IGF-I concentrations
Trial Locations
- Locations (1)
Division of Pediatrics, Karolinska University Hospital
🇸🇪Stockholm, Sweden