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

Diabetes Mellitus Type 1 Clinical Trial

— BAS  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01271517
• Other study ID #: Eudract-number 2005-001726-80
• Status: Active, not recruiting
• Phase: Phase 4
• First received: January 5, 2011
• Last updated: January 5, 2011
• Start date: September 2005

Study information

• Verified date: January 2011
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 1
• Diabetes Mellitus, Type 1

Intervention

Drug:
• NPH insulin
Treatment twice daily with Insulatard plus Novorapid at meals. Doses adjusted according to bloodsugar
• Glargine
Treatment once daily with Lantus plus Novorapid at meals. Doses adjusted according to bloodsugars
• Detemir
Treatment twice daily with Levemir plus Novorapid at meals. Doses adjusted according to bloodsugars

Locations

Country	Name	City	State
Sweden	Division of Pediatrics, Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Stimulated C-peptide	Sustacal stimulated C-peptide after an overnight fast	2 weeks and 3, 6 and 12 month	No
Secondary	IGF-I	Serum IGF-I concentrations	diagnosis, 2 weeks, 3,6,9 and 12 month	No