Safety Follow-up on Children and Adolescents With Type 1 Diabetes Treated With Insulin Detemir. An Extension Trial - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00623194

Purpose

This trial is conducted in Europe. The aim of this research is to assess the safety of continuous treatment with insulin detemir following participation in trial NN304-1689 on antibody development.

Condition	Intervention	Phase
Diabetes Mellitus, Type 1	Drug: insulin detemir Drug: insulin aspart	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A 52-Week, Multinational, Multi-Centre, Open-Labelled Extension Trial of Insulin Detemir in Children and Adolescents 3-17 Years With Type 1 Diabetes on a Basal-Bolus Regimen With Insulin Aspart as Bolus Insulin

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Insulin aspart Insulin Detemir

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

To study the development of insulin detemir-insulin aspart cross-reacting antibodies [ Time Frame: At 104 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To study the development of insulin detemir specific antibodies and insulin aspart specific antibodies [ Time Frame: At 104 weeks ] [ Designated as safety issue: Yes ]
To follow the glycaemic control, measured as HbA1c, of insulin detemir [ Time Frame: At 104 weeks ] [ Designated as safety issue: No ]
Fasting plasma glucose values [ Time Frame: At 104 weeks ] [ Designated as safety issue: No ]
Incidence of hypoglycaemic episodes (mild, moderate, severe and biochemical) overall, daytime and night-time [ Time Frame: At 104 weeks ] [ Designated as safety issue: Yes ]
BMI and SD-score (z-score) for weight [ Time Frame: At 104 weeks ] [ Designated as safety issue: Yes ]
Incidence of adverse events [ Time Frame: At 104 weeks ] [ Designated as safety issue: Yes ]
Incidence of diabetic ketoacidosis requiring hospitalisation [ Time Frame: At 104 weeks ] [ Designated as safety issue: Yes ]
Insulin dose [ Time Frame: At 104 weeks ] [ Designated as safety issue: No ]
Laboratory safety parameters (haematology and biochemistry) and fundoscopy/fundus photography [ Time Frame: At 104 weeks ] [ Designated as safety issue: Yes ]
Vital signs [ Time Frame: At 104 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	February 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: insulin detemir Treat-to-target dose titration scheme, injection s.c., once or twice daily. Drug: insulin aspart Treat-to target dose titration scheme, injection s.c., at larger meals.

Eligibility

Ages Eligible for Study:	3 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Informed Consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject). The parents or legal representative of the subject must sign and date the Informed Consent Form.
Finalised 52 weeks of treatment with insulin detemir in trial NN304-1689.
Fertile females (girls who have had their first menstrual period) must use adequate contraception (barrier methods, contraceptive pills or intrauterine device (IUD)) if there is any risk of pregnancy in the opinion of the Investigator. For Denmark and France only contraceptive pills or intrauterine device are considered as adequate contraceptive methods.

Exclusion Criteria:

Significant concomitant disease such as endocrine, hepatic, renal, cardiac, respiratory, neurological, gastrointestinal, malignant or pancreatic diseases as judged by the Investigator.
Pregnant or the intention of becoming pregnant.
Previous participation in this trial (defined as enrolment).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623194

Locations

Bulgaria

Pleven, Bulgaria, 5800
Czech Republic

Prague 5, Czech Republic, 15018
Denmark

Odense, Denmark, 5000
Finland

Seinäjoki, Finland, 60220
France

PARIS, France, 75015
Hungary

Miskolc, Hungary, 3501
Macedonia, The Former Yugoslav Republic of

Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Poland

Kielce, Poland, 25-734
Russian Federation

Moscow, Russian Federation, 119049
Turkey

ISTANBUL, Turkey, 34093
United Kingdom

Aberdeen, United Kingdom, AB25 2ZG

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Jens Larsen, MD

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN304-1690, EudraCT No: 2006-002478-23
Study First Received:	February 14, 2008
Last Updated:	April 7, 2009
ClinicalTrials.gov Identifier:	NCT00623194 History of Changes
Health Authority:	Czech Republic: State Institute for Drug Control; Denmark: Danish Medicines Agency; Finland: National Agency for Medicines; Hungary: National Institute of Pharmacy; Russia: Federal Service for control in Health and Social development; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Bulgaria: Bulgarian Drug Agency; France: Afssaps - French Health Products Safety Agency; Macedonia, The Former Yugoslav Republic of: Drug Agency, Ministry of Health; Poland: The Office for Registration of Medicinal Products, Medical Devices; and Biocides, Central Evidence of Clinical Trials; Turkey: Ministry of Health

Study placed in the following topic categories:

Hypoglycemic Agents
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Insulin, Asp(B28)-
Diabetes Mellitus

Endocrine System Diseases
Diabetes Mellitus Type 1
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1
Physiological Effects of Drugs

Insulin, Asp(B28)-
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on September 03, 2009