Diabetes Mellitus, Type 1Phase 3NCT03220425
Evaluation of the Efficacy and Safety of Insulin Detemir Compared With That of NPH Insulin in Subjects With Type 1 Diabetes.
A Phase 3 study testing Insulin detemir and NPH insulin in people with Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 93 sites in 10 countries.
Trial summary
The aim of this trial is to evaluate the efficacy and safety of insulin detemir using the 2400 nmol/mL formulation to optimise dosing in subjects with type 1 diabetes on a basal (once daily)-bolus regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Insulin detemir and NPH insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 752 participants
- Where
- 93 sitesin 10 countries
- Study dates
- 1 Feb 2001to 12 Nov 2001
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent obtained before any trial-related activities
- Type 1 diabetes diagnosed and classified according to aetiology
- Duration of type 1 diabetes equal to or more than 12 months
- Glycosylated haemoglobin less than or equal to 12 percent based on analysis from central laboratory
- Able and willing to perform self-blood glucose monitoring
Who cannot join
- Proliferative retinopathy
- Total basal insulin dose of more than 100 IU per day
- Recurrent major hypoglycaemia - that would interfere with trial participation (as judged by the investigator)
- Known unawareness of hypoglycaemia
- Previous treatment with insulin detemir
Trial locations and contacts
93 sites in 10 countries.
93 sites in 10 countries
United Kingdom24 sites
Novo Nordisk Investigational Site
Abergavenny, NP7 7EG
Novo Nordisk Investigational Site
Blackburn, BB3 3LR
Novo Nordisk Investigational Site
Bolton, BL1 4QS
Novo Nordisk Investigational Site
Bristol, BS10 5NB
Novo Nordisk Investigational Site
Cosham, PO6 3LY
Novo Nordisk Investigational Site
Derby, DE7 1DY
Novo Nordisk Investigational Site
Gillingham, ME7 5NY
Novo Nordisk Investigational Site
Glasgow, G4 0SF
Novo Nordisk Investigational Site
Glasgow, G42 9TY
Novo Nordisk Investigational Site
Guildford, GU2 7XX
Novo Nordisk Investigational Site
Kettering, NN16 8UZ
Novo Nordisk Investigational Site
Livingstone, EH54 6PP
Novo Nordisk Investigational Site
Llantrisant, CF72 8XR
Novo Nordisk Investigational Site
London, SE1 7EH
Novo Nordisk Investigational Site
Newcastle, NE7 7DN
Novo Nordisk Investigational Site
Northampton, NN1 5BD
Novo Nordisk Investigational Site
Norwich, NR1 3SR
Novo Nordisk Investigational Site
Nottingham, NG5 1PB
Novo Nordisk Investigational Site
Oxford, OX2 6HE
Novo Nordisk Investigational Site
Sheffield, S5 7AU
Novo Nordisk Investigational Site
Sidcup, DA14 6LT
Novo Nordisk Investigational Site
Stevenage, SG1 4AB
Novo Nordisk Investigational Site
Taunton, TA1 5DA
Novo Nordisk Investigational Site
York, YO3 7HE
France14 sites
Novo Nordisk Investigational Site
Angers, 49033
Novo Nordisk Investigational Site
Avignon, 84902
Novo Nordisk Investigational Site
Bondy, 93143
Novo Nordisk Investigational Site
Corbeil-Essonnes, 91106
Novo Nordisk Investigational Site
La Rochelle, 17019
Novo Nordisk Investigational Site
Le Creusot, 71200
Novo Nordisk Investigational Site
Montpellier, 34295
Novo Nordisk Investigational Site
Narbonne, 11108
Novo Nordisk Investigational Site
Nevers, 58033
Novo Nordisk Investigational Site
Paris, 75475
Novo Nordisk Investigational Site
Paris, 75877
Novo Nordisk Investigational Site
Paris, 75908
Novo Nordisk Investigational Site
Poitiers, 86000
Novo Nordisk Investigational Site
Rennes, 35056
Sweden10 sites
Novo Nordisk Investigational Site
Falun, 791 82
Novo Nordisk Investigational Site
Helsingborg, 251 87
Novo Nordisk Investigational Site
Karlstad, 651 85
Novo Nordisk Investigational Site
Lund, 221 85
Novo Nordisk Investigational Site
Örebro, 701 85
Novo Nordisk Investigational Site
Skövde, 541 85
Novo Nordisk Investigational Site
Stockholm, 141 86
Novo Nordisk Investigational Site
Umeå, 901 85
Novo Nordisk Investigational Site
Uppsala, 751 85
Novo Nordisk Investigational Site
Värnamo, 331 85
Norway9 sites
Novo Nordisk Investigational Site
Bergen, NO-5012
Novo Nordisk Investigational Site
Jessheim, 2050
Novo Nordisk Investigational Site
Kongsvinger, 2226
Novo Nordisk Investigational Site
Oslo, 0284
Novo Nordisk Investigational Site
Oslo, 0407
Novo Nordisk Investigational Site
Sarpsborg, 1702
Novo Nordisk Investigational Site
Stavanger, 4011
Novo Nordisk Investigational Site
Stord, 5400
Novo Nordisk Investigational Site
Trondheim, 7006
Australia8 sites
Novo Nordisk Investigational Site
Ashford, 5035
Novo Nordisk Investigational Site
Box Hill, 3128
Novo Nordisk Investigational Site
Broadmeadow, New South Wales, 2292
Novo Nordisk Investigational Site
Clayton, 3168
Novo Nordisk Investigational Site
Garran, 2605
Novo Nordisk Investigational Site
Ringwood, 3134
Novo Nordisk Investigational Site
Stones Corner, 4120
Novo Nordisk Investigational Site
Woodville, 5011
Denmark8 sites
Novo Nordisk Investigational Site
Århus C, 8000
Novo Nordisk Investigational Site
Copenhagen, 2400
Novo Nordisk Investigational Site
Fredericia, 7000
Novo Nordisk Investigational Site
Frederiksberg, 2000
Novo Nordisk Investigational Site
Hvidovre, 2650
Novo Nordisk Investigational Site
Middelfart
Novo Nordisk Investigational Site
Odense, 5000
Novo Nordisk Investigational Site
Vejle, 7100
Netherlands8 sites
Novo Nordisk Investigational Site
Amersfoort, 3816 CP
Novo Nordisk Investigational Site
Apeldoorn, 7334 DZ
Novo Nordisk Investigational Site
Brunssum, 6442 BE
Novo Nordisk Investigational Site
Eindhoven, 5631 BM
Novo Nordisk Investigational Site
Haarlem, 2012 CE
Novo Nordisk Investigational Site
Hengelo, 7555 DL
Novo Nordisk Investigational Site
The Hague, 2512 VA
Novo Nordisk Investigational Site
Utrecht, 3582 KE
Belgium5 sites
Novo Nordisk Investigational Site
Bornem, 2880
Novo Nordisk Investigational Site
Edegem, 2650
Novo Nordisk Investigational Site
Ghent, 9000
Novo Nordisk Investigational Site
Leuven, 3000
Novo Nordisk Investigational Site
Luxembourg, 1210
Finland5 sites
Novo Nordisk Investigational Site
Espoo, 02740
Novo Nordisk Investigational Site
Helsinki, 00250
Novo Nordisk Investigational Site
Joensuu, 80210
Novo Nordisk Investigational Site
Kemi, 94100
Novo Nordisk Investigational Site
Vantaa, 01400
Ireland2 sites
Novo Nordisk Investigational Site
Dublin, DUBLIN 8
Novo Nordisk Investigational Site
Dublin
About this study
Official title: A Six Month, Multi-centre, Open-label, Parallel Efficacy and Safety Comparison of Insulin Detemir and NPH Insulin in Subjects With Type 1 Diabetes on a Basal-bolus Regimen.
The aim of this trial is to evaluate the efficacy and safety of insulin detemir using the 2400 nmol/mL formulation to optimise dosing in subjects with type 1 diabetes on a basal (once daily)-bolus regimen.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Insulin detemir, NPH insulin
- Medical subject headings
- 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
NPH insulinDrug
| Study group | Role | What they receive |
|---|---|---|
| Insulin detemir | Experimental | Not described Receives: Drug: Insulin detemir |
| NPH insulin | Active comparator | Not described Receives: Drug: NPH insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the level of glycosylated haemoglobin(HbA1c)
Measured: From start of treatment visit 2 (week 0) until end of treatment visit 8 (week 26)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start1 Feb 2001
- Primary completion12 Nov 2001
- Study completion12 Nov 2001
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 Diabetes Mellitus, Type 1Studies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 752 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220425
- Sponsor's protocol ID
- NN304-1335
- Status last verified
- Jul 2017
- First submitted
- 13 Jul 2017
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk Disclosure commitment on novonordisk-trials.com
Publications
Russell-Jones D, Simpson R, Hylleberg B, Draeger E, Bolinder J. Effects of QD insulin detemir or neutral protamine Hagedorn on blood glucose control in patients with type I diabetes mellitus using a basal-bolus regimen. Clin Ther. 2004 May;26(5):724-36. doi: 10.1016/s0149-2918(04)90072-0.
PubMed 15220016
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Six Month, Multi-centre, Open-label, Parallel Efficacy and Safety Comparison of Insulin Detemir and NPH Insulin in Subjects With Type 1 Diabetes on a Basal-bolus Regimen.
- ClinicalTrials.gov ID
- NCT03220425
- Acronym / sponsor ID
- NN304-1335
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 752 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2001 (actual)
- Primary completion
- 12 Nov 2001 (actual)
- Study completion
- 12 Nov 2001 (actual)
- First posted
- 18 Jul 2017 (actual)
- 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 aim of this trial is to evaluate the efficacy and safety of insulin detemir using the 2400 nmol/mL formulation to optimise dosing in subjects with type 1 diabetes on a basal (once daily)-bolus regimen.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin detemir | Experimental | Drug: Insulin detemir |
| NPH insulin | Active comparator | Drug: NPH insulin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed and dated informed consent obtained before any trial-related activities
- Type 1 diabetes diagnosed and classified according to aetiology
- Duration of type 1 diabetes equal to or more than 12 months
- Glycosylated haemoglobin less than or equal to 12 percent based on analysis from central laboratory
- Able and willing to perform self-blood glucose monitoring
Key exclusion criteria (5 listed)
- Proliferative retinopathy
- Total basal insulin dose of more than 100 IU per day
- Recurrent major hypoglycaemia - that would interfere with trial participation (as judged by the investigator)
- Known unawareness of hypoglycaemia
- Previous treatment with insulin detemir
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 detemir |
| NPH insulin | Drug | NPH insulin |
Primary outcome
The change in the level of glycosylated haemoglobin(HbA1c)
Time frame: From start of treatment visit 2 (week 0) until end of treatment visit 8 (week 26)
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 18 Jul 2017.
- Results publication: PubMed 15220016Russell-Jones D, Simpson R, Hylleberg B, Draeger E, Bolinder J. Effects of QD insulin detemir or neutral protamine Hagedorn on blood glucose control in patients with type I diabetes mellitus using a basal-bolus regimen. Clin Ther. 2004 May;26(5):724-36. doi: 10.1016/s0149-2918(04)90072-0.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk Disclosure commitment on novonordisk-trials.com
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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.
The record lists no contact. Use the official record to reach the sponsor.
93 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin detemir and NPH insulin in people with Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 93 sites in 10 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 5 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 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 93 sites in United Kingdom, France, Sweden, Norway, Australia and 5 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?
The change in the level of glycosylated haemoglobin(HbA1c) (time frame: From start of treatment visit 2 (week 0) until end of treatment visit 8 (week 26)). 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 NCT03220425, 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 18 Jul 2017.