DiabetesPhase 3NCT00435019

Comparison of NPH Insulin and Insulin Detemir in Children and Adolescents With Type 1 Diabetes

A Phase 3 study testing insulin detemir, insulin NPH and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 43 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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 Read more about this study

Who is it for?: Ages 2 to 16 years
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 1
What is being tested?: insulin detemir, insulin NPH and insulin aspart
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 348 participants
Where: 43 sitesin 11 countries
Study dates: Feb 2007to Sep 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

Insulin detemir naive
Type 1 diabetes for at least 12 months
HbA1c lesser than or equal to 11.0%

Who cannot join

Significant concomitant diseases

Trial locations and contacts

43 sites in 11 countries.

Country

City, postcode or hospital

43 sites in 11 countries

Finland6 sites

Novo Nordisk Investigational Site
Espoo, 02740
Novo Nordisk Investigational Site
Helsinki, 00029
Novo Nordisk Investigational Site
Oulu, 90029
Novo Nordisk Investigational Site
Seinäjoki, 60220
Novo Nordisk Investigational Site
Tampere, 33520
Novo Nordisk Investigational Site
Turku, 20100

Other trials in Finland

Poland6 sites

Novo Nordisk Investigational Site
Gdansk, 80-211
Novo Nordisk Investigational Site
Kielce, 25-734
Novo Nordisk Investigational Site
Siedlce, 08-110
Novo Nordisk Investigational Site
Warsaw, 00-576
Novo Nordisk Investigational Site
Warsaw, 01-184
Novo Nordisk Investigational Site
Warsaw, 04-730

Other trials in Poland

Turkey (Türkiye)5 sites

Novo Nordisk Investigational Site
Altunizade-Istanbul, 34662
Novo Nordisk Investigational Site
Antalya, 07059
Novo Nordisk Investigational Site
Istanbul, 34093
Novo Nordisk Investigational Site
Izmir, 35340
Novo Nordisk Investigational Site
Kayseri, 38010

Other trials in Turkey (Türkiye)

United Kingdom5 sites

Novo Nordisk Investigational Site
Aberdeen, AB25 2ZG
Novo Nordisk Investigational Site
Birmingham, B4 6NH
Novo Nordisk Investigational Site
Cambridge, CB2 2QQ
Novo Nordisk Investigational Site
Dundee, DD1 9SY
Novo Nordisk Investigational Site
Norfolk, NR4 7UY

Other trials in United Kingdom

Denmark4 sites

Novo Nordisk Investigational Site
Glostrup Municipality, 2600
Novo Nordisk Investigational Site
Kolding, 6000
Novo Nordisk Investigational Site
Odense, 5000
Novo Nordisk Investigational Site
Viborg, 8800

Other trials in Denmark

France4 sites

Novo Nordisk Investigational Site
Angers, 49033
Novo Nordisk Investigational Site
Montpellier, 34295
Novo Nordisk Investigational Site
Paris, 75015
Novo Nordisk Investigational Site
Toulouse, 31059

Other trials in France

Russia4 sites

Novo Nordisk Investigational Site
Moscow, 117036
Novo Nordisk Investigational Site
Moscow, 119049
Novo Nordisk Investigational Site
Moscow, 125373
Novo Nordisk Investigational Site
Saint Petersburg, 191144

Other trials in Russia

Bulgaria3 sites

Novo Nordisk Investigational Site
Pleven, 5800
Novo Nordisk Investigational Site
Sofia, 1606
Novo Nordisk Investigational Site
Varna, 9010

Other trials in Bulgaria

Czechia3 sites

Novo Nordisk Investigational Site
Olomouc, 77520
Novo Nordisk Investigational Site
Pardubice, 53203
Novo Nordisk Investigational Site
Prague, 15018

Other trials in Czechia

Hungary2 sites

Novo Nordisk Investigational Site
Budapest, 1083
Novo Nordisk Investigational Site
Miskolc, 3501

Other trials in Hungary

North Macedonia1 site

Novo Nordisk Investigational Site
Skopje, 1000

Other trials in North Macedonia

About this study

Official title: An Efficacy and Safety Comparison of Insulin Detemir vs. NPH Insulin in Children and Adolescents Diagnosed With Type 1 Diabetes

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

Conditions: Diabetes, Diabetes Mellitus, Type 1
Being tested: insulin detemir, insulin NPH, insulin aspart
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

insulin detemirDrug
s.c. injection, once or twice daily.
insulin NPHDrug
s.c. injection, once or twice daily.
insulin aspartDrug
s.c. injection, at main meals.

Study groups in NCT00435019
Study group	Role	What they receive
insulin detemir	Experimental	insulin detemir + insulin aspart Receives: Drug: insulin detemir; Drug: insulin aspart
NPH insulin	Experimental	NPH insulin + insulin aspart Receives: Drug: insulin NPH; Drug: insulin aspart

What is being measured

The primary outcome is the main question the study is designed to answer.

Glycosylated Haemoglobin A1c (HbA1c)
Glycosylated haemoglobin A1c (HbA1c) measured after 52 weeks of treatment and analysed by central laboratory.
Measured: after 52 weeks of treatment

Secondary outcomes (2)

Number of Subjects Reporting Adverse Events
Number of subjects reporting adverse events during the trial (from week -2 to week 52).
For details, please refer to the adverse events section.
Measured: from week -2 to week 52
Observed Insulin Antibody Values
Observed insulin antibody values for insulin detemir specific antibodies, insulin aspart specific antibodies and insulin detemir/insulin aspart cross-reacting antibodies.
Measured: at 0 and 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2007Sep 2008

First posted14 Feb 2007 (estimated)
Study startFeb 2007
Primary completionSep 2008
Study completionSep 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 348 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00435019
Sponsor's protocol ID: NN304-1689
Other IDs: 2006-000051-18
Status last verified: Jan 2017
First submitted: 13 Feb 2007
Last updated: 10 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Thalange N, Bereket A, Larsen J, Hiort LC, Peterkova V. Treatment with insulin detemir or NPH insulin in children aged 2-5 yr with type 1 diabetes mellitus. Pediatr Diabetes. 2011 Nov;12(7):632-41. doi: 10.1111/j.1399-5448.2010.00750.x. Epub 2011 Mar 21.
PubMed 21418455
Thalange N, Bereket A, Larsen J, Hiort LC, Peterkova V. Insulin analogues in children with Type 1 diabetes: a 52-week randomized clinical trial. Diabet Med. 2013 Feb;30(2):216-25. doi: 10.1111/dme.12041.
PubMed 23094597
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.
PubMed 27600385

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Efficacy and Safety Comparison of Insulin Detemir vs. NPH Insulin in Children and Adolescents Diagnosed With Type 1 Diabetes
ClinicalTrials.gov ID: NCT00435019
Acronym / sponsor ID: NN304-1689
Conditions: Diabetes, Diabetes Mellitus, Type 1
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 348 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Feb 2007
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 14 Feb 2007 (estimated)
Results: Posted 8 Dec 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This trial is conducted in Europe.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
insulin detemir	Experimental	Drug: insulin detemir, Drug: insulin aspartinsulin detemir + insulin aspart
NPH insulin	Experimental	Drug: insulin NPH, Drug: insulin aspartNPH insulin + insulin aspart

Who may qualify

Ages: 2 to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Insulin detemir naive
Type 1 diabetes for at least 12 months
HbA1c lesser than or equal to 11.0%

Key exclusion criteria (1 listed)

Significant concomitant diseases

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
insulin detemirs.c. injection, once or twice daily.	Drug	insulin detemir
insulin NPHs.c. injection, once or twice daily.	Drug	NPH insulin
insulin asparts.c. injection, at main meals.	Drug	NPH insulin, insulin detemir

Primary outcome

Glycosylated Haemoglobin A1c (HbA1c)
Time frame: after 52 weeks of treatment
Glycosylated haemoglobin A1c (HbA1c) measured after 52 weeks of treatment and analysed by central laboratory.

2 secondary outcomes

Number of Subjects Reporting Adverse Events
Time frame: from week -2 to week 52
Observed Insulin Antibody Values
Time frame: at 0 and 52 weeks

Results and safety

Results posted to the registry on 8 Dec 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Insulin Detemir	177	164
NPH Insulin	171	161

Primary outcome: Glycosylated Haemoglobin A1c (HbA1c)

Time frame: after 52 weeks of treatment. Mean (Standard Error). Unit: Percent (%) glycosylated haemoglobin

Measure	Insulin Detemir n = 171	NPH Insulin n = 168
Value	8.75 (0.11)	8.64 (0.11)

Insulin Detemir vs NPH Insulin: Mean Difference (Final Values): 0.12 (95% CI -0.12 to 0.36), ANCOVA

Population analysed: Full Analysis Set (FAS) is defined as all randomised subjects exposed to at least one dose of trial product with a postbaseline observation, classified according to randomised treatment.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from week 0 to week 52.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Insulin Detemir	14 of 177 (7.9%)	131 of 177 (74%)	Not reported
NPH Insulin	20 of 170 (11.8%)	134 of 170 (78.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21418455Thalange N, Bereket A, Larsen J, Hiort LC, Peterkova V. Treatment with insulin detemir or NPH insulin in children aged 2-5 yr with type 1 diabetes mellitus. Pediatr Diabetes. 2011 Nov;12(7):632-41. doi: 10.1111/j.1399-5448.2010.00750.x. Epub 2011 Mar 21.
Results publication: PubMed 23094597Thalange N, Bereket A, Larsen J, Hiort LC, Peterkova V. Insulin analogues in children with Type 1 diabetes: a 52-week randomized clinical trial. Diabet Med. 2013 Feb;30(2):216-25. doi: 10.1111/dme.12041.
Derived from this study: PubMed 27600385Thalange 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.
Clinical Trials at Novo NordiskLink provided by the sponsor.

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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Registry (GCR, 1452) study director

Novo Nordisk A/S

43 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing insulin detemir, insulin NPH and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 43 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in Finland, Poland, Turkey (Türkiye), United Kingdom, Denmark and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycosylated Haemoglobin A1c (HbA1c) (time frame: after 52 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00435019, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2017.