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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Insulatard

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

Group Type ACTIVE_COMPARATOR

NPH insulin

Intervention Type DRUG

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

Lantus

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

Group Type ACTIVE_COMPARATOR

Glargine

Intervention Type DRUG

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

Levemir

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

Group Type ACTIVE_COMPARATOR

Detemir

Intervention Type DRUG

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

Interventions

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NPH insulin

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

Intervention Type DRUG

Glargine

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

Intervention Type DRUG

Detemir

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No