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Safety Follow-up on Children and Adolescents With Type 1 Diabetes Treated With Insulin Detemir. An Extension to Trial NN304-1689

NCT ID: NCT00623194

Last Updated: 2016-11-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-09-30

Brief Summary

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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 (NCT00435019) on antibody development.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 1

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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insulin detemir

Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)

Group Type EXPERIMENTAL

insulin detemir

Intervention Type DRUG

Treat-to-target dose titration scheme (individually adjusted), injection s.c. (under the skin), once or twice daily.

insulin aspart

Intervention Type DRUG

Treat-to target dose titration scheme (individually adjusted), injection s.c. (under the skin), at larger meals.

Interventions

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insulin detemir

Treat-to-target dose titration scheme (individually adjusted), injection s.c. (under the skin), once or twice daily.

Intervention Type DRUG

insulin aspart

Treat-to target dose titration scheme (individually adjusted), injection s.c. (under the skin), at larger meals.

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

3 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Pleven, , Bulgaria

Site Status

Novo Nordisk Investigational Site

Sofia, , Bulgaria

Site Status

Novo Nordisk Investigational Site

Varna, , Bulgaria

Site Status

Novo Nordisk Investigational Site

Olomouc, , Czechia

Site Status

Novo Nordisk Investigational Site

Pardubice, , Czechia

Site Status

Novo Nordisk Investigational Site

Prague, , Czechia

Site Status

Novo Nordisk Investigational Site

Glostrup Municipality, , Denmark

Site Status

Novo Nordisk Investigational Site

Kolding, , Denmark

Site Status

Novo Nordisk Investigational Site

Odense, , Denmark

Site Status

Novo Nordisk Investigational Site

Helsinki, , Finland

Site Status

Novo Nordisk Investigational Site

Oulu, , Finland

Site Status

Novo Nordisk Investigational Site

Seinäjoki, , Finland

Site Status

Novo Nordisk Investigational Site

Turku, , Finland

Site Status

Novo Nordisk Investigational Site

Paris, , France

Site Status

Novo Nordisk Investigational Site

Toulouse, , France

Site Status

Novo Nordisk Investigational Site

Budapest, , Hungary

Site Status

Novo Nordisk Investigational Site

Miskolc, , Hungary

Site Status

Novo Nordisk Investigational Site

Skopje, , North Macedonia

Site Status

Novo Nordisk Investigational Site

Gdansk, , Poland

Site Status

Novo Nordisk Investigational Site

Kielce, , Poland

Site Status

Novo Nordisk Investigational Site

Warsaw, , Poland

Site Status

Novo Nordisk Investigational Site

Moscow, , Russia

Site Status

Novo Nordisk Investigational Site

Moscow, , Russia

Site Status

Novo Nordisk Investigational Site

Moscow, , Russia

Site Status

Novo Nordisk Investigational Site

Saint Petersburg, , Russia

Site Status

Novo Nordisk Investigational Site

Altunizade-Istanbul, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Antalya, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Izmir, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Aberdeen, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Dundee, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Norfolk, , United Kingdom

Site Status

Countries

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Bulgaria Czechia Denmark Finland France Hungary North Macedonia Poland Russia Turkey (Türkiye) United Kingdom

References

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Thalange N, Bereket A, Jensen LB, Hiort LC, Peterkova V. Development of Insulin Detemir/Insulin Aspart Cross-Reacting Antibodies Following Treatment with Insulin Detemir: 104-week Study in Children and Adolescents with Type 1 Diabetes Aged 2-16 Years. Diabetes Ther. 2016 Dec;7(4):713-724. doi: 10.1007/s13300-016-0196-5. Epub 2016 Sep 6.

Reference Type BACKGROUND
PMID: 27600385 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2006-002478-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN304-1690

Identifier Type: -

Identifier Source: org_study_id