NCT00623194|CompletedPhase 3Results

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

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

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

NN304-16902006-002478-23

Study Type

interventional

Target

146

Locations

11 countries

Sites

Timeline

RegisteredFeb 2008

StartedFeb 2008

CompletionSep 2009

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

146

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline

Completed

Started Feb 2008

Typical duration for phase_3 diabetes

Geographic Reach

11 countries

32 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.6 years study duration

Study Start

First participant enrolled

February 1, 2008

Completed

13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2008

Completed

11 days until next milestone

First Posted

Study publicly available on registry

February 25, 2008

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

January 24, 2011

Completed

Last Updated

November 28, 2016

Status Verified

October 1, 2016

Enrollment Period

1.6 years

First QC Date

February 14, 2008

Results QC Date

September 5, 2010

Last Update Submit

October 17, 2016

Conditions

Diabetes Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

Insulin Detemir-insulin Aspart Cross-reacting Antibodies
Estimated amount of bound antibodies in percent of total antibodies. The primary analysis of cross-reacting antibodies included results from blood samples taken before insulin detemir and less than 3 hours after insulin aspart injection. In addition, an analysis was done including results from samples taken before insulin detemir and less than 2.5 hours after insulin aspart injection.
week 0, 52 and 104

Secondary Outcomes (16)

Development of Insulin Detemir Specific Antibodies and Insulin Aspart Specific Antibodies
At 0, 52 and 104 weeks
Glycosylated Haemoglobin A1c (HbA1c)
At 104 weeks
Fasting Plasma Glucose Values
At 104 weeks
Hypoglycaemic Episodes
Weeks 0-104
BMI (Body Mass Index)
At 104 weeks
+11 more secondary outcomes

Study Arms (1)

insulin detemir

EXPERIMENTAL

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

Drug: insulin detemirDrug: insulin aspart

Interventions

insulin detemirDRUG

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

insulin detemir

insulin aspartDRUG

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

insulin detemir

Eligibility Criteria

Age3 Years - 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

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.

You may not qualify if:

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).

Contact the study team to confirm eligibility.