DiabetesPhase 3NCT00312156
Comparison of Efficacy and Safety of Insulin Detemir and NPH Insulin 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 42 sites in 16 countries.
Trial summary
The trial is conducted in Europe and Middle East. The aim of the trial is to compare the use of Insulin Detemir once or twice daily combined with mealtime Insulin Aspart against that of NPH Insulin once or twice daily combined with mealtime Insulin Aspart. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1
- What is being tested?
- insulin detemir, insulin NPH and insulin aspart
- How many people
- 347 participants
- Where
- 42 sitesin 16 countries
- Study dates
- Aug 2002to Aug 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Type 1 diabetes for at least 12 months
- Informed consent obtained
- BMI: 6-7 years: less than or equal to 19 kg/m2, 8-9 years: less than or equal to 20 kg/m2, 10-11 years: less than or equal to 22 kg/m2, 12-13 years: less than or equal to 24 kg/m2 and 14-17 years: less than or equal to 27 kg/m2.
- HbA1c equal to or less than 12.0%
Who cannot join
- Proliferate retinopathy or maculopathy
- Total daily insulin dose greater than 2.00 IU/kg
- Any condition or disease that rule out trial participation according to the judgement of the investigator.
- Mental incapacity, unwillingness or language barriers precluding understanding or cooperation.
- A life-style incompatible with trial participation
Trial locations and contacts
42 sites in 16 countries.
42 sites in 16 countries
Sweden6 sites
Novo Nordisk Investigational Site
Helsingborg, 251 87
Novo Nordisk Investigational Site
Linköping, 581 85
Novo Nordisk Investigational Site
Lund, 221 85
Novo Nordisk Investigational Site
Malmö, 205 02
Novo Nordisk Investigational Site
Örebro, 701 85
Novo Nordisk Investigational Site
Stockholm, 171 76
United Kingdom5 sites
Novo Nordisk Investigational Site
Aberdeen, AB25 2ZG
Novo Nordisk Investigational Site
Belfast, BT12 6BE
Novo Nordisk Investigational Site
Birmingham, B9 5SS
Novo Nordisk Investigational Site
Glasgow, G51 4TF
Novo Nordisk Investigational Site
Stirling, FK8 2AU
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
France4 sites
Novo Nordisk Investigational Site
Caen, 14000
Novo Nordisk Investigational Site
Paris, 75015
Novo Nordisk Investigational Site
Rennes, 35056
Novo Nordisk Investigational Site
Toulouse, 31059
Germany4 sites
Novo Nordisk Investigational Site
Frankfurt, 60590
Novo Nordisk Investigational Site
Hanover, 30173
Novo Nordisk Investigational Site
Kiel, 24105
Novo Nordisk Investigational Site
Stuttgart, 70176
Norway4 sites
Novo Nordisk Investigational Site
Bodø, 8092
Novo Nordisk Investigational Site
Gjøvik, NO-2819
Novo Nordisk Investigational Site
Sarpsborg, 1702
Novo Nordisk Investigational Site
Tønsberg, 3116
Netherlands3 sites
Novo Nordisk Investigational Site
Eindhoven, 5623 EJ
Novo Nordisk Investigational Site
Spijkenisse, 3201 GZ
Novo Nordisk Investigational Site
Utrecht, 3582 KE
Belgium2 sites
Novo Nordisk Investigational Site
Bree, 3960
Novo Nordisk Investigational Site
Edegem, 2650
Finland2 sites
Novo Nordisk Investigational Site
Helsinki, 00029
Novo Nordisk Investigational Site
Oulu, 90029
Spain2 sites
Novo Nordisk Investigational Site
Leganés, 28911
Novo Nordisk Investigational Site
Madrid, 28034
About this study
The trial is conducted in Europe and Middle East. The aim of the trial is to compare the use of Insulin Detemir once or twice daily combined with mealtime Insulin Aspart against that of NPH Insulin once or twice daily combined with mealtime Insulin Aspart. The trial involves children and adolescents with Type 1 Diabetes.
- 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
insulin NPHDrug
insulin aspartDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: after 26 weeks
Secondary outcomes (5)
Adverse events
body weight
Antibodies
Blood glucose
Hypoglycaemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2006 (estimated)
- Study startAug 2002
- Primary completionAug 2003
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312156
- Sponsor's protocol ID
- NN304-1379
- Status last verified
- Jan 2017
- First submitted
- 5 Apr 2006
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Robertson KJ, Schoenle E, Gucev Z, Mordhorst L, Gall MA, Ludvigsson J. Insulin detemir compared with NPH insulin in children and adolescents with Type 1 diabetes. Diabet Med. 2007 Jan;24(1):27-34. doi: 10.1111/j.1464-5491.2007.02024.x.
PubMed 17227321
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Safety of Insulin Detemir and NPH Insulin in Children and Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT00312156
- Acronym / sponsor ID
- NN304-1379
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Aug 2002
- Primary completion
- Aug 2003 (actual)
- Study completion
- Aug 2003 (actual)
- First posted
- 7 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial is conducted in Europe and Middle East. The aim of the trial is to compare the use of Insulin Detemir once or twice daily combined with mealtime Insulin Aspart against that of NPH Insulin once or twice daily combined with mealtime Insulin Aspart. The trial involves children and adolescents with Type 1 Diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Type 1 diabetes for at least 12 months
- Informed consent obtained
- BMI: 6-7 years: less than or equal to 19 kg/m2, 8-9 years: less than or equal to 20 kg/m2, 10-11 years: less than or equal to 22 kg/m2, 12-13 years: less than or equal to 24 kg/m2 and 14-17 years: less than or equal to 27 kg/m2.
- HbA1c equal to or less than 12.0%
Key exclusion criteria (5 listed)
- Proliferate retinopathy or maculopathy
- Total daily insulin dose greater than 2.00 IU/kg
- Any condition or disease that rule out trial participation according to the judgement of the investigator.
- Mental incapacity, unwillingness or language barriers precluding understanding or cooperation.
- A life-style incompatible with trial participation
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 detemir | Drug | – |
| insulin NPH | Drug | – |
| insulin aspart | Drug | – |
Primary outcome
HbA1c
Time frame: after 26 weeks
5 secondary outcomes
Adverse events
body weight
Antibodies
Blood glucose
Hypoglycaemia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2017.
- Results publication: PubMed 17227321Robertson KJ, Schoenle E, Gucev Z, Mordhorst L, Gall MA, Ludvigsson J. Insulin detemir compared with NPH insulin in children and adolescents with Type 1 diabetes. Diabet Med. 2007 Jan;24(1):27-34. doi: 10.1111/j.1464-5491.2007.02024.x.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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
42 sites in 16 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 42 sites in 16 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 4 inclusion and 5 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 27 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in Sweden, United Kingdom, Denmark, France, Germany and 11 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
HbA1c (time frame: after 26 weeks). 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 NCT00312156, which also lists 1 linked publication.
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 27 Jan 2017.