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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01271517

Acronym

BAS

Enrollment

120

Registered

2011-01-06

Start date

2005-09-30

Completion date

Unknown

Last updated

2011-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 1

Keywords

Basal insulin, long acting insulin analogs, metabolic control, HbA1c, C-peptide, IGF-I, GH, IGFBP

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.

Interventions

DRUGNPH insulin

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

DRUGGlargine

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

DRUGDetemir

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

7 Years to 17 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
IGF-I	diagnosis, 2 weeks, 3,6,9 and 12 month	Serum IGF-I concentrations
Stimulated C-peptide	2 weeks and 3, 6 and 12 month	Sustacal stimulated C-peptide after an overnight fast

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026