Comparison of NPH Insulin and Insulin Detemir in Children and Adolescents With Type 1 Diabetes
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00435019
First received: February 13, 2007
Last updated: June 26, 2012
Last verified: June 2012
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Purpose
This trial is conducted in Europe.
The aim of this research is to compare the efficacy and safety of treatment with NPH insulin and insulin detemir. You will be treated with either insulin detemir or NPH insulin once or twice daily as basal insulin. Additionally you will receive insulin aspart as bolus insulin
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Diabetes Mellitus, Type 1 |
Drug: insulin detemir Drug: insulin NPH Drug: insulin aspart |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Efficacy and Safety Comparison of Insulin Detemir vs. NPH Insulin in Children and Adolescents Diagnosed With Type 1 Diabetes |
Resource links provided by NLM:
Genetics Home Reference related topics:
type 1 diabetes
Drug Information available for:
Insulin, NPH
Insulin human
Insulin, isophane
Insulin aspart
Insulin detemir
U.S. FDA Resources
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Glycosylated Haemoglobin A1c (HbA1c) [ Time Frame: after 52 weeks of treatment ] [ Designated as safety issue: No ]Glycosylated haemoglobin A1c (HbA1c) measured after 52 weeks of treatment and analysed by central laboratory.
Secondary Outcome Measures:
- Number of Subjects Reporting Adverse Events [ Time Frame: from week -2 to week 52 ] [ Designated as safety issue: Yes ]
Number of subjects reporting adverse events during the trial (from week -2 to week 52).
For details, please refer to the adverse events section.
- Observed Insulin Antibody Values [ Time Frame: at 0 and 52 weeks ] [ Designated as safety issue: Yes ]Observed insulin antibody values for insulin detemir specific antibodies, insulin aspart specific antibodies and insulin detemir/insulin aspart cross-reacting antibodies.
| Enrollment: | 347 |
| Study Start Date: | February 2007 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: insulin detemir
insulin detemir + insulin aspart
|
Drug: insulin detemir
s.c. injection, once or twice daily.
Drug: insulin aspart
s.c. injection, at main meals.
|
|
Experimental: NPH insulin
NPH insulin + insulin aspart
|
Drug: insulin NPH
s.c. injection, once or twice daily.
Drug: insulin aspart
s.c. injection, at main meals.
|
Eligibility| Ages Eligible for Study: | 2 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Insulin detemir naive
- Type 1 diabetes for at least 12 months
- HbA1c lesser than or equal to 11.0%
Exclusion Criteria:
- Significant concomitant diseases
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00435019
Locations
| Bulgaria | |
| Varna, Bulgaria, 9010 | |
| Czech Republic | |
| Praha 5, Czech Republic, 15006 | |
| Denmark | |
| Glostrup, Denmark, 2600 | |
| Finland | |
| Oulu, Finland, 90029 | |
| France | |
| Paris, France | |
| Hungary | |
| Budapest, Hungary | |
| Macedonia, The Former Yugoslav Republic of | |
| Skopje, Macedonia, The Former Yugoslav Republic of, 1000 | |
| Poland | |
| Warszawa, Poland | |
| Russian Federation | |
| Moscow, Russian Federation, 119049 | |
| Turkey | |
| Istanbul, Turkey, 111 | |
| United Kingdom | |
| Birmingham, United Kingdom | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Jens Larsen, MD | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT00435019 History of Changes |
| Other Study ID Numbers: | NN304-1689, 2006-000051-18 |
| Study First Received: | February 13, 2007 |
| Results First Received: | November 3, 2009 |
| Last Updated: | June 26, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Russia: Federal Service for control in Health and Social development Turkey: Ministry of Health Drug and Pharmaceutical Department Denmark: Danish Medicines Agency Hungary: National Institute of Pharmacy Finland: Finnish Medicines Agency Bulgaria: Bulgarian Drug Agency Czech Republic: State Institute for Drug Control Poland: The Office for Registration of Medicinal Products, Medical Devices; and Biocides, Central Evidence of Clinical Trials Macedonia, The Former Yugoslav Republic of: Drug Agency, Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
Insulin aspart Insulin Insulin, NPH Insulin, Long-Acting Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013