Back to resultsSafety of Insulin Detemir in Children With Type 1 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
insulin detemir
insulin NPH
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
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
Sites / Locations
- Novo Nordisk Investigational Site
Outcomes
Primary Outcome Measures
Incidence of hypoglycaemic episodes
Secondary Outcome Measures
Adverse events
Laboratory assessments and other safety endpoints
HbA1C, self monitored blood glucose and within-subject variability of glucose
Height
Insulin doses
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00605137
Brief Title
Safety of Insulin Detemir in Children With Type 1 Diabetes
Official Title
Safety of Insulin Detemir and Insulin NPH in Children With Type 1 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 21, 2004 (Actual)
Primary Completion Date
April 23, 2005 (Actual)
Study Completion Date
April 23, 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
insulin detemir
Intervention Type
Drug
Intervention Name(s)
insulin NPH
Primary Outcome Measure Information:
Title
Incidence of hypoglycaemic episodes
Time Frame
during treatment
Secondary Outcome Measure Information:
Title
Adverse events
Title
Laboratory assessments and other safety endpoints
Title
HbA1C, self monitored blood glucose and within-subject variability of glucose
Title
Height
Title
Insulin doses
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
1000005
Country
Japan
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Safety of Insulin Detemir in Children With Type 1 Diabetes
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