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

Sponsor

Karolinska Institutet (Other)

Overall Status

Unknown status

CT.gov ID

NCT01271517

Collaborator

(none)

120

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Type 1	Drug: NPH insulin Drug: Glargine Drug: Detemir	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Sep 1, 2005

Anticipated Primary Completion Date :

Mar 1, 2011

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Insulatard

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

Drug: NPH insulin

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

Active Comparator: Lantus

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

Drug: Glargine

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

Active Comparator: Levemir

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

Drug: Detemir

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

Outcome Measures

Primary Outcome Measures

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

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