DiabetesPhase 3NCT00569400
Comparison of Human Insulin Produced by the Current Process and the NN729 Process in Type 1 Diabetes
A Phase 3 study testing human insulin in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 15 sites in 4 countries.
Trial summary
This trial is conducted in Asia and Oceania. The aim of this trial is to compare the efficacy and safety of human insulin produced by the current process and the NN729 process in type 1 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?
- human insulin
- How many people
- 241 participants
- Where
- 15 sitesin 4 countries
- Study dates
- 1 May 2003to 19 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
- Duration of diabetes for at least 12 months
- Basal/bolus treatment with human insulin for at least 2 months preceding trial start
- Body Mass Index (BMI) lesser than or equal to 35.0 kg/m2
- HbA1c lesser than or equal to 12.0%
Who cannot join
- Proliferative retinopathy or maculopathy requiring acute treatment or laser treatment within the last 6 months
- Any condition that the investigator and/or sponsor feel would interfere with trial participation
- Known or suspected allergy against trial product or related products
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
Australia7 sites
Novo Nordisk Investigational Site
Broadmeadow, New South Wales, 2292
Novo Nordisk Investigational Site
Dunedin, NZ
Novo Nordisk Investigational Site
Hamilton, NZ
Novo Nordisk Investigational Site
Keswick, South Australia, 5035
Novo Nordisk Investigational Site
Kippa-Ring, 4021
Novo Nordisk Investigational Site
Miranda, 2228
Novo Nordisk Investigational Site
Stones Corner, 4120
Philippines4 sites
Novo Nordisk Investigational Site
Cebu City, 6000
Novo Nordisk Investigational Site
Iloilo City
Novo Nordisk Investigational Site
Makati City, 1200
Novo Nordisk Investigational Site
Marikina City, 1800
Malaysia3 sites
Novo Nordisk Investigational Site
Cheras, 56000
Novo Nordisk Investigational Site
Georgetown, Penang, 10450
Novo Nordisk Investigational Site
Kota Bharu, Kelantan, 16150
About this study
Official title: Comparison of Efficacy and Safety of Human Insulin Produced by the Current Process and the NN729 Process in Type 1 Diabetes Mellitus
This trial is conducted in Asia and Oceania. The aim of this trial is to compare the efficacy and safety of human insulin produced by the current process and the NN729 process in type 1 diabetes.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Being tested
- human 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.
human insulinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of human insulin antibodies
Measured: after 26 weeks of treatment
Secondary outcomes (2)
Change of human insulin antibodies
Frequency 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 2007 (estimated)
- Study start1 May 2003
- Primary completion19 Jan 2004
- Study completion19 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
- NCT00569400
- Sponsor's protocol ID
- NN729-1541
- Status last verified
- Feb 2017
- First submitted
- 5 Dec 2007
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Safety of Human Insulin Produced by the Current Process and the NN729 Process in Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00569400
- Acronym / sponsor ID
- NN729-1541
- 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
- 1 May 2003 (actual)
- Primary completion
- 19 Jan 2004 (actual)
- Study completion
- 19 Jan 2004 (actual)
- First posted
- 7 Dec 2007 (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 Asia and Oceania. The aim of this trial is to compare the efficacy and safety of human insulin produced by the current process and the NN729 process in type 1 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 (4 listed)
- Duration of diabetes for at least 12 months
- Basal/bolus treatment with human insulin for at least 2 months preceding trial start
- Body Mass Index (BMI) lesser than or equal to 35.0 kg/m2
- HbA1c lesser than or equal to 12.0%
Key exclusion criteria (3 listed)
- Proliferative retinopathy or maculopathy requiring acute treatment or laser treatment within the last 6 months
- Any condition that the investigator and/or sponsor feel would interfere with trial participation
- Known or suspected allergy against trial product or related products
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 |
|---|---|---|
| human insulin | Drug | – |
Primary outcome
Change of human insulin antibodies
Time frame: after 26 weeks of treatment
2 secondary outcomes
Change of human insulin antibodies
Frequency 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 Feb 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
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing human insulin in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 15 sites in 4 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 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Australia, Philippines, Malaysia, Hong Kong. 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?
Change of human insulin antibodies (time frame: after 26 weeks of 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 27 Feb 2017.