Safety of Insulin Detemir in Children With Type 1 Diabetes

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-21

Study Completion Date

2005-04-23

Brief Summary

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This trial is conducted in Japan. The aim of trial is to investigate the safety of insulin detemir and insulin NPH in children with type 1 diabetes.

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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insulin detemir

Intervention Type DRUG

insulin NPH

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 1 diabetes for at least one year
* Current treatment of basal-bolus regimen for at least 12 weeks using an intermediate/long-acting human insulin and insulin aspart and/or soluble human insulin
* HbA1C below 11.0%
* Willing to comply with Investigator's instructions
* Able and willing to perform self-monitoring of capillary blood glucose and to take measures in case of hypoglycaemia

Exclusion Criteria

* Impaired renal function
* Impaired hepatic function
* Known hypoglycaemia unawareness or recurrent major hypoglycaemia (as judged by the Investigator or Sub-Investigator)
* Proliferative retinopathy or maculopathy requiring acute treatment
* Uncontrolled treated/untreated hypertension
* Current treatment with total daily insulin dose of more than 2.00 IU/kg
* Current treatment or expected at the screening to start treatment with systemic corticosteroids

Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No