DiabetesPhase 3NCT01486940
Comparison of Insulin Detemir Plus Insulin Aspart With Insulin NPH Plus Human Soluble Insulin in Subjects With Type 1 Diabetes
A Phase 3 study testing insulin detemir, insulin aspart and insulin NPH in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 75 sites in 15 countries.
Trial summary
This trial is conducted in Europe and South America. The aim of this trial is to compare the glycaemic control of insulin detemir plus insulin aspart with that of insulin NPH plus human soluble insulin in subjects with type 1 diabetes on a basal/bolus regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1
- What is being tested?
- insulin detemir, insulin aspart and insulin NPH
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 598 participants
- Where
- 75 sitesin 15 countries
- Study dates
- Mar 2002to Oct 2002
- 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
- Type 1 diabetes for at least 12 months
- Current treatment with any basal/bolus regimen or any biphasic insulin treatment for at least 6 months
- BMI below or equal to 35 kg/m^2
- HbA1c below or equal to 12%
Who cannot join
- Proliferative retinopathy or maculopathy requiring acute treatment
- Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the Investigator)
- Subjects with known hypoglycaemic unawareness as judged by the Investigator
Trial locations and contacts
75 sites in 15 countries.
75 sites in 15 countries
Italy14 sites
Novo Nordisk Investigational Site
Alessandria
Novo Nordisk Investigational Site
Asti, 14100
Novo Nordisk Investigational Site
Bari, 70100
Novo Nordisk Investigational Site
Bergamo, 24127
Novo Nordisk Investigational Site
Catania, 95124
Novo Nordisk Investigational Site
Catania, 95126
Novo Nordisk Investigational Site
Genova, 16132
Novo Nordisk Investigational Site
Lucca, 55100
Novo Nordisk Investigational Site
Milan, 20132
Novo Nordisk Investigational Site
Padova, 35143
Novo Nordisk Investigational Site
Prato, 59100
Novo Nordisk Investigational Site
Ravenna, 48121
Novo Nordisk Investigational Site
Roma, 00161
Novo Nordisk Investigational Site
Torino, 10126
France11 sites
Novo Nordisk Investigational Site
Angers
Novo Nordisk Investigational Site
Grenoble, 38043
Novo Nordisk Investigational Site
Lille, 59037
Novo Nordisk Investigational Site
Lorient, 56322
Novo Nordisk Investigational Site
Montpellier, 34295
Novo Nordisk Investigational Site
Mougins, 06250
Novo Nordisk Investigational Site
Narbonne, 11108
Novo Nordisk Investigational Site
Paris, 75014
Novo Nordisk Investigational Site
Paris, 75475
Novo Nordisk Investigational Site
Paris, 75877
Novo Nordisk Investigational Site
Poitiers, 86000
Denmark9 sites
Novo Nordisk Investigational Site
Århus C, 8000
Novo Nordisk Investigational Site
Copenhagen, 2400
Novo Nordisk Investigational Site
Hillerød, 3400
Novo Nordisk Investigational Site
Hjørring, 9800
Novo Nordisk Investigational Site
Holbæk, 4300
Novo Nordisk Investigational Site
Køge, 4600
Novo Nordisk Investigational Site
Silkeborg, 8600
Novo Nordisk Investigational Site
Slagelse, 4200
Novo Nordisk Investigational Site
Svendborg, 5700
Czechia7 sites
Novo Nordisk Investigational Site
Hradec Králové, 50036
Novo Nordisk Investigational Site
Liberec, 46001
Novo Nordisk Investigational Site
Plzen - Lochotin, 30460
Novo Nordisk Investigational Site
Prague, 10034
Novo Nordisk Investigational Site
Prague, 12000
Novo Nordisk Investigational Site
Prague, 140 00
Novo Nordisk Investigational Site
Prague, 150 18
Finland7 sites
Novo Nordisk Investigational Site
Kemi, 94100
Novo Nordisk Investigational Site
Kokkola, 67200
Novo Nordisk Investigational Site
Kuopio, 70210
Novo Nordisk Investigational Site
Oulu, FI-90220
Novo Nordisk Investigational Site
Pärnu, 80010
Novo Nordisk Investigational Site
Rovaniemi, 96400
Novo Nordisk Investigational Site
Viljandi, 71024
Norway7 sites
Novo Nordisk Investigational Site
Arendal, 4841
Novo Nordisk Investigational Site
Gjettum, 1346
Novo Nordisk Investigational Site
Gjøvik, NO-2819
Novo Nordisk Investigational Site
Kongsberg, NO-3602
Novo Nordisk Investigational Site
Kongsvinger, 2212
Novo Nordisk Investigational Site
Kristiansand, 4604
Novo Nordisk Investigational Site
Rådal, 5235
Poland7 sites
Novo Nordisk Investigational Site
Bydgoszcz, 85-094
Novo Nordisk Investigational Site
Bydgoszcz, 85-822
Novo Nordisk Investigational Site
Gdansk, 80-211
Novo Nordisk Investigational Site
Krakow, 31-501
Novo Nordisk Investigational Site
Lodz, 90-030
Novo Nordisk Investigational Site
Lublin, 20-718
Novo Nordisk Investigational Site
Szczecin, 71-455
Greece3 sites
Novo Nordisk Investigational Site
Athens, GR-10552
Novo Nordisk Investigational Site
Athens, GR-115 27
Novo Nordisk Investigational Site
Athens, GR-11527
Argentina2 sites
Novo Nordisk Investigational Site
Junín
Novo Nordisk Investigational Site
Morón
Russia2 sites
Novo Nordisk Investigational Site
Moscow, 117036
Novo Nordisk Investigational Site
Moscow, 125315
Slovakia2 sites
Novo Nordisk Investigational Site
Košice, 043 80
Novo Nordisk Investigational Site
Moldava nad Bodvou, 045 01
About this study
Official title: A Multi-centre, Multinational, Open-labelled, Randomised, Parallel-Group Comparison of Insulin Detemir Plus Insulin Aspart With NPH Insulin Plus Human Soluble Insulin in Subjects With Type 1 Diabetes on a Basal-Bolus Regimen
This trial is conducted in Europe and South America. The aim of this trial is to compare the glycaemic control of insulin detemir plus insulin aspart with that of insulin NPH plus human soluble insulin in subjects with type 1 diabetes on a basal/bolus regimen.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Being tested
- insulin detemir, insulin aspart, insulin NPH, human soluble insulin
- 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
Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily
insulin aspartDrug
Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals
insulin NPHDrug
Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily
human soluble insulinDrug
Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals
| Study group | Role | What they receive |
|---|---|---|
| Basal/bolus regimen 1 | Experimental | Not described Receives: Drug: insulin detemir; Drug: insulin aspart |
| Basal/bolus regimen 2 | Active comparator | Not described Receives: Drug: insulin NPH; Drug: human soluble insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c (glycosylated haemoglobin)
Secondary outcomes (4)
Intra-subject variation in home measured blood glucose (3-point blood glucose profiles)
8-point blood glucose profiles
Incidence of self-recorded hypoglycaemic episodes
Incidence of adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startMar 2002
- Primary completionOct 2002
- Study completionOct 2002
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
- 598 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
- NCT01486940
- Sponsor's protocol ID
- NN304-1374
- Status last verified
- Jan 2017
- First submitted
- 5 Dec 2011
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hermansen K, Fontaine P, Kukolja KK, Peterkova V, Leth G, Gall MA. Insulin analogues (insulin detemir and insulin aspart) versus traditional human insulins (NPH insulin and regular human insulin) in basal-bolus therapy for patients with type 1 diabetes. Diabetologia. 2004 Apr;47(4):622-9. doi: 10.1007/s00125-004-1365-z.
PubMed 15298338
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
- A Multi-centre, Multinational, Open-labelled, Randomised, Parallel-Group Comparison of Insulin Detemir Plus Insulin Aspart With NPH Insulin Plus Human Soluble Insulin in Subjects With Type 1 Diabetes on a Basal-Bolus Regimen
- ClinicalTrials.gov ID
- NCT01486940
- Acronym / sponsor ID
- NN304-1374
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 598 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- Primary completion
- Oct 2002 (actual)
- Study completion
- Oct 2002 (actual)
- First posted
- 7 Dec 2011 (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.
This trial is conducted in Europe and South America. The aim of this trial is to compare the glycaemic control of insulin detemir plus insulin aspart with that of insulin NPH plus human soluble insulin in subjects with type 1 diabetes on a basal/bolus regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Basal/bolus regimen 1 | Experimental | Drug: insulin detemir, Drug: insulin aspart |
| Basal/bolus regimen 2 | Active comparator | Drug: insulin NPH, Drug: human soluble insulin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 1 diabetes for at least 12 months
- Current treatment with any basal/bolus regimen or any biphasic insulin treatment for at least 6 months
- BMI below or equal to 35 kg/m^2
- HbA1c below or equal to 12%
Key exclusion criteria (3 listed)
- Proliferative retinopathy or maculopathy requiring acute treatment
- Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the Investigator)
- Subjects with known hypoglycaemic unawareness as judged by the Investigator
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 detemirIndividually adjusted dose administered subcutaneously (s.c., under the skin) twice daily | Drug | Basal/bolus regimen 1 |
| insulin aspartIndividually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals | Drug | Basal/bolus regimen 1 |
| insulin NPHIndividually adjusted dose administered subcutaneously (s.c., under the skin) twice daily | Drug | Basal/bolus regimen 2 |
| human soluble insulinIndividually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals | Drug | Basal/bolus regimen 2 |
Primary outcome
HbA1c (glycosylated haemoglobin)
4 secondary outcomes
Intra-subject variation in home measured blood glucose (3-point blood glucose profiles)
8-point blood glucose profiles
Incidence of self-recorded hypoglycaemic episodes
Incidence of adverse events
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 15298338Hermansen K, Fontaine P, Kukolja KK, Peterkova V, Leth G, Gall MA. Insulin analogues (insulin detemir and insulin aspart) versus traditional human insulins (NPH insulin and regular human insulin) in basal-bolus therapy for patients with type 1 diabetes. Diabetologia. 2004 Apr;47(4):622-9. doi: 10.1007/s00125-004-1365-z.
- 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
75 sites in 15 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 aspart and insulin NPH in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 75 sites in 15 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 3 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 75 sites in Italy, France, Denmark, Czechia, Finland and 10 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 (glycosylated haemoglobin). 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 NCT01486940, 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.