- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00605137
Safety of Insulin Detemir in Children With Type 1 Diabetes
February 22, 2017 updated by: Novo Nordisk A/S
Safety of Insulin Detemir and Insulin NPH in Children With Type 1 Diabetes Mellitus
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
83
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tokyo, Japan, 1000005
- Novo Nordisk Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of hypoglycaemic episodes
Time Frame: during treatment
|
during treatment
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Secondary Outcome Measures
Outcome Measure |
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Adverse events
|
Height
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Insulin doses
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Laboratory assessments and other safety endpoints
|
HbA1C, self monitored blood glucose and within-subject variability of glucose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 21, 2004
Primary Completion (Actual)
April 23, 2005
Study Completion (Actual)
April 23, 2005
Study Registration Dates
First Submitted
January 17, 2008
First Submitted That Met QC Criteria
January 23, 2008
First Posted (Estimate)
January 30, 2008
Study Record Updates
Last Update Posted (Actual)
February 24, 2017
Last Update Submitted That Met QC Criteria
February 22, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Immune System Diseases
- Autoimmune Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 1
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Insulin
- Insulin, Globin Zinc
- Insulin Detemir
- Insulin, Isophane
- Isophane Insulin, Human
- Isophane insulin, beef
Other Study ID Numbers
- NN304-1604
- JapicCTI-R070014 (Registry Identifier: japic)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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