DiabetesPhase 3NCT00604656
Comparison of Insulin Aspart Produced by the NN2000 Process to the Current Process in Type 1 Diabetes
A Phase 3 study testing insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 34 sites in 5 countries.
Trial summary
This trial is conducted in Europe. The aim of this trial is to investigate the safety and efficacy of insulin aspart produced by current process compared to that of insulin aspart produced by NN2000 process in subjects with type 2 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 aspart
- How many people
- 241 participants
- Where
- 34 sitesin 5 countries
- Study dates
- 5 May 2003to 29 Jan 2004
- 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
- Subjects with type 1 diabetes
- Duration of diabetes for at least 12 months
- Treatment with insulin aspart for at least 3 months before trial start
- Body Mass Index (BMI) below 35.0 kg/m2
- HbA1c below 12.0%
Who cannot join
- Total insulin dosage more than 1.4 IU/kg/day
- Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the investigator)
- Known hypoglycaemia unawareness as judged by the investigator
- Known hypersensitivity or allergy
Trial locations and contacts
34 sites in 5 countries.
34 sites in 5 countries
Germany15 sites
Novo Nordisk Investigational Site
Bad Kreuznach, 55545
Novo Nordisk Investigational Site
Bad Neuenahr-Ahrweiler, 53474
Novo Nordisk Investigational Site
Diez, 65582
Novo Nordisk Investigational Site
Frankfurt, 60325
Novo Nordisk Investigational Site
Friedrichsthal, 66299
Novo Nordisk Investigational Site
Karlsruhe, 76133
Novo Nordisk Investigational Site
Marktheidenfeld, 97828
Novo Nordisk Investigational Site
Marl, 45770
Novo Nordisk Investigational Site
Oberursel, 61440
Novo Nordisk Investigational Site
Rehlingen-Siersburg, 66780
Novo Nordisk Investigational Site
Saarbrücken, 66121
Novo Nordisk Investigational Site
Saint Ingbert, 66386
Novo Nordisk Investigational Site
Simmern, 55469
Novo Nordisk Investigational Site
Speyer, 67346
Novo Nordisk Investigational Site
Würzburg, 97072
Italy10 sites
Novo Nordisk Investigational Site
Cagliari, 09124
Novo Nordisk Investigational Site
Chiavari, 16043
Novo Nordisk Investigational Site
Città di Castello, 06012
Novo Nordisk Investigational Site
Lucca, 55100
Novo Nordisk Investigational Site
Orvieto, 05018
Novo Nordisk Investigational Site
Parma, 43100
Novo Nordisk Investigational Site
Perugia, 06126
Novo Nordisk Investigational Site
Rimini, 47900
Novo Nordisk Investigational Site
Roma, 00128
Novo Nordisk Investigational Site
Roma, 00133
Poland5 sites
Novo Nordisk Investigational Site
Bytom, 41-902
Novo Nordisk Investigational Site
Mazowieckie, 09-400
Novo Nordisk Investigational Site
Radom, 26-600
Novo Nordisk Investigational Site
Warsaw, 03-242
Novo Nordisk Investigational Site
Wroclaw, 50-306
Czechia2 sites
Novo Nordisk Investigational Site
Hradec Králové, 500 36
Novo Nordisk Investigational Site
Prague, 15018
Hungary2 sites
Novo Nordisk Investigational Site
Budapest, 1096
Novo Nordisk Investigational Site
Nyíregyháza, 4400
About this study
Official title: A Six Months, Multi-centre, Open, Randomised, Parallel Safety and Efficacy Comparison of NovoRapid® Produced by the Current Process and Insulin Aspart With the Same Formulation as NovoRapid®, Produced by the NN2000 Process in Subjects With Type 1 Diabetes on a Basal/Bolus Regimen
This trial is conducted in Europe. The aim of this trial is to investigate the safety and efficacy of insulin aspart produced by current process compared to that of insulin aspart produced by NN2000 process in subjects with type 2 diabetes.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Being tested
- 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 aspartDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin aspart antibodies
Measured: After 6 months treatment
Secondary outcomes (3)
Occurrence of adverse events
Incidence of hypoglycaemic episodes
HbA1c
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study start5 May 2003
- Primary completion29 Jan 2004
- Study completion29 Jan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 241 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
- NCT00604656
- Sponsor's protocol ID
- NN2000-1542
- Status last verified
- Feb 2017
- First submitted
- 17 Jan 2008
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Six Months, Multi-centre, Open, Randomised, Parallel Safety and Efficacy Comparison of NovoRapid® Produced by the Current Process and Insulin Aspart With the Same Formulation as NovoRapid®, Produced by the NN2000 Process in Subjects With Type 1 Diabetes on a Basal/Bolus Regimen
- ClinicalTrials.gov ID
- NCT00604656
- Acronym / sponsor ID
- NN2000-1542
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 5 May 2003 (actual)
- Primary completion
- 29 Jan 2004 (actual)
- Study completion
- 29 Jan 2004 (actual)
- First posted
- 30 Jan 2008 (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. The aim of this trial is to investigate the safety and efficacy of insulin aspart produced by current process compared to that of insulin aspart produced by NN2000 process in subjects with type 2 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 (5 listed)
- Subjects with type 1 diabetes
- Duration of diabetes for at least 12 months
- Treatment with insulin aspart for at least 3 months before trial start
- Body Mass Index (BMI) below 35.0 kg/m2
- HbA1c below 12.0%
Key exclusion criteria (4 listed)
- Total insulin dosage more than 1.4 IU/kg/day
- Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the investigator)
- Known hypoglycaemia unawareness as judged by the investigator
- Known hypersensitivity or allergy
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 aspart | Drug | – |
Primary outcome
Insulin aspart antibodies
Time frame: After 6 months treatment
3 secondary outcomes
Occurrence of adverse events
Incidence of hypoglycaemic episodes
HbA1c
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 1 Mar 2017.
- 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
34 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 34 sites in 5 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 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 1 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 34 sites in Germany, Italy, Poland, Czechia, Hungary. 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?
Insulin aspart antibodies (time frame: After 6 months treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2017.