DiabetesPhase 3NCT00095082
Safety and Efficacy of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart as Mealtime Insulin in Type 1 Diabetes
A Phase 3 study testing insulin detemir, insulin glargine and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 81 sites in 7 countries.
Trial summary
This trial is conducted in Europe and the United States of America (USA). The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type I diabetes. 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 glargine and insulin aspart
- How many people
- 447 participants
- Where
- 81 sitesin 7 countries
- Study dates
- Sep 2004to Dec 2005
- 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 basal-bolus insulin regimen for more than or equal to 3 months
- HbA1c less than or equal to 11.0%
Who cannot join
- Proliferative retinopathy or maculopathy
- Recurrent major hypoglycaemia
- Impaired hepatic or renal function
- Cardiac problems or uncontrolled hypertension
Trial locations and contacts
81 sites in 7 countries.
81 sites in 7 countries
United States28 sites
Novo Nordisk Investigational Site
Anaheim, California, 92801
Novo Nordisk Investigational Site
Asheville, North Carolina, 28803
Novo Nordisk Investigational Site
Atlanta, Georgia, 30318
Novo Nordisk Investigational Site
Berlin, New Jersey, 08009
Novo Nordisk Investigational Site
Chicago, Illinois, 60607
Novo Nordisk Investigational Site
Dallas, Texas, 75235
Novo Nordisk Investigational Site
Dallas, Texas, 75390-8858
Novo Nordisk Investigational Site
Detroit, Michigan, 48235
Novo Nordisk Investigational Site
Hollywood, Florida, 33021
Novo Nordisk Investigational Site
Houston, Texas, 77030
Novo Nordisk Investigational Site
Huntington Beach, California, 92646
Novo Nordisk Investigational Site
Hyattsville, Maryland, 20782
Novo Nordisk Investigational Site
Idaho Falls, Idaho, 83404-7596
Novo Nordisk Investigational Site
Inglewood, California, 90301
Novo Nordisk Investigational Site
Irvine, California, 92618
Novo Nordisk Investigational Site
Jacksonville, Florida, 32216
Novo Nordisk Investigational Site
La Jolla, California, 92037
Novo Nordisk Investigational Site
Lake Mary, Florida, 32746
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89119-6100
Novo Nordisk Investigational Site
Melbourne, Florida, 32901
Novo Nordisk Investigational Site
Omaha, Nebraska, 68114
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19107
Novo Nordisk Investigational Site
San Antonio, Texas, 78229
Novo Nordisk Investigational Site
Sea Girt, New Jersey, 08750
Novo Nordisk Investigational Site
St Louis, Missouri, 63110
Novo Nordisk Investigational Site
Tampa, Florida, 33613
Novo Nordisk Investigational Site
Topeka, Kansas, 66606
Novo Nordisk Investigational Site
Vero Beach, Florida, 32960
Germany17 sites
Novo Nordisk Investigational Site
Alsdorf, 52477
Novo Nordisk Investigational Site
Bad Kreuznach, 55545
Novo Nordisk Investigational Site
Dormagen, 41539
Novo Nordisk Investigational Site
Dresden, 01307
Novo Nordisk Investigational Site
Flensburg, 24939
Novo Nordisk Investigational Site
Friedrichsthal, 66299
Novo Nordisk Investigational Site
Genthin, 39307
Novo Nordisk Investigational Site
Hamburg, 20251
Novo Nordisk Investigational Site
Hamburg, 21073
Novo Nordisk Investigational Site
Hamburg, 22607
Novo Nordisk Investigational Site
Herrenberg, 71083
Novo Nordisk Investigational Site
Kippenheim, 77971
Novo Nordisk Investigational Site
Rehlingen-Siersburg, 66780
Novo Nordisk Investigational Site
Saint Ingbert, 66386
Novo Nordisk Investigational Site
Speyer, 67346
Novo Nordisk Investigational Site
Völklingen, 66333
Novo Nordisk Investigational Site
Würzburg, 97072
United Kingdom12 sites
Novo Nordisk Investigational Site
Abergavenny, NP7 7EG
Novo Nordisk Investigational Site
Ayr, KA6 6DX
Novo Nordisk Investigational Site
Brighton, BN2 5BE
Novo Nordisk Investigational Site
Bristol, BS10 5NB
Novo Nordisk Investigational Site
Cosham, PO6 3LY
Novo Nordisk Investigational Site
Dundee, DD1 9SY
Novo Nordisk Investigational Site
Glasgow, G4 0SF
Novo Nordisk Investigational Site
Livingstone, EH54 6PP
Novo Nordisk Investigational Site
Plymouth, PL8 8DQ
Novo Nordisk Investigational Site
Sheffield, S5 7AU
Novo Nordisk Investigational Site
Watford, WD18 0HB
Novo Nordisk Investigational Site
Wirral, Merseyside, CH63 4JY
France7 sites
Novo Nordisk Investigational Site
Angers, 49033
Novo Nordisk Investigational Site
Antibes, 06600
Novo Nordisk Investigational Site
Brest, 29609
Novo Nordisk Investigational Site
Grenoble, 38043
Novo Nordisk Investigational Site
La Rochelle, 17019
Novo Nordisk Investigational Site
Mougins, 06250
Novo Nordisk Investigational Site
Toulouse, 31054
Netherlands6 sites
Novo Nordisk Investigational Site
Almere Stad, 1315 RA
Novo Nordisk Investigational Site
Apeldoorn, 7334 DZ
Novo Nordisk Investigational Site
Capelle aan den IJssel, 2906 ZC
Novo Nordisk Investigational Site
Dordrecht, 3318 AT
Novo Nordisk Investigational Site
Leeuwarden, 8934 AD
Novo Nordisk Investigational Site
Zoetermeer, 2725 NA
Sweden6 sites
Novo Nordisk Investigational Site
Norrköping, 601 82
Novo Nordisk Investigational Site
Örebro, 701 85
Novo Nordisk Investigational Site
Stockholm, 112 81
Novo Nordisk Investigational Site
Stockholm, 182 88
Novo Nordisk Investigational Site
Umeå, 901 85
Novo Nordisk Investigational Site
Vaxjo, 351 85
Finland5 sites
Novo Nordisk Investigational Site
Helsinki, 00250
Novo Nordisk Investigational Site
Kuopio, 70210
Novo Nordisk Investigational Site
Oulu, 90029
Novo Nordisk Investigational Site
Pori, 28500
Novo Nordisk Investigational Site
Vantaa, 01400
About this study
Official title: Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart Versus Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes
This trial is conducted in Europe and the United States of America (USA). The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type I diabetes.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Being tested
- insulin detemir, insulin glargine, insulin aspart
- Keywords
- Diabetes Mellitus, Type I
- 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 glargineDrug
insulin aspartDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: after 1 year trial period
Secondary outcomes (5)
Adverse events
Body weight
Hypoglycemia
Blood glucose
Insulin Treatment Satisfaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2004 (estimated)
- Study startSep 2004
- Primary completionDec 2005
- Study completionDec 2005
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
- 447 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
- NCT00095082
- Sponsor's protocol ID
- NN304-1430
- Other IDs
- 2004-000086-35, 2004
- Status last verified
- Jan 2017
- First submitted
- 29 Oct 2004
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Heller S, Koenen C, Bode B. Comparison of insulin detemir and insulin glargine in a basal-bolus regimen, with insulin aspart as the mealtime insulin, in patients with type 1 diabetes: a 52-week, multinational, randomized, open-label, parallel-group, treat-to-target noninferiority trial. Clin Ther. 2009 Oct;31(10):2086-97. doi: 10.1016/j.clinthera.2009.10.006.
PubMed 19922879
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
- Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart Versus Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT00095082
- Acronym / sponsor ID
- NN304-1430
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Keywords
- Diabetes Mellitus, Type I
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 447 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 1 Nov 2004 (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 the United States of America (USA). The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type I diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 1 diabetes for at least 12 months
- Current treatment with basal-bolus insulin regimen for more than or equal to 3 months
- HbA1c less than or equal to 11.0%
Key exclusion criteria (4 listed)
- Proliferative retinopathy or maculopathy
- Recurrent major hypoglycaemia
- Impaired hepatic or renal function
- Cardiac problems or uncontrolled hypertension
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 glargine | Drug | – |
| insulin aspart | Drug | – |
Primary outcome
HbA1c
Time frame: after 1 year trial period
5 secondary outcomes
Adverse events
Body weight
Hypoglycemia
Blood glucose
Insulin Treatment Satisfaction
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 19922879Heller S, Koenen C, Bode B. Comparison of insulin detemir and insulin glargine in a basal-bolus regimen, with insulin aspart as the mealtime insulin, in patients with type 1 diabetes: a 52-week, multinational, randomized, open-label, parallel-group, treat-to-target noninferiority trial. Clin Ther. 2009 Oct;31(10):2086-97. doi: 10.1016/j.clinthera.2009.10.006.
- 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
81 sites in 7 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 glargine and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 81 sites in 7 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 4 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 81 sites in United States, Germany, United Kingdom, France, Netherlands and 2 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 1 year trial period). 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 NCT00095082, 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.