DiabetesPhase 1NCT01448070
Comparison of Human Insulin Produced by the Current Process and the NN729 Process in Healthy Volunteers
A Phase 1 study testing human insulin in people with Diabetes and Healthy, run by Novo Nordisk A/S at 1 site in United Kingdom.
Trial summary
This trial is conducted in Europe. The aim of this trial is to show that the product of the new production process has a similar pharmacological profile to the traditional process used for the current commercial product Actrapid®. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- What is being tested?
- human insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Oct 2002to 20 Dec 2002
- Phase
- Phase 1
- 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 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant
- Fasting blood glucose below or equal to 6 mmol/L
- Body Mass Index (BMI) 22.0-27.0 kg/m^2 (both inclusive)
Who cannot join
- Participated in another clinical study with an investigational drug within the last 4 weeks
- Any condition requiring the regular use of any medication, including herbal remedies, over the counter medicines and vitamins. Occasional paracetamol is acceptable
- Known or suspected allergy to the trial product or related products
- Family history of type 1 diabetes
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Novo Nordisk Investigational Site
Manchester, M15 6SH
About this study
Official title: A Single Centre, Randomized, Balanced Double Blind, Cross-over Trial Investigating the Bioequivalence of Actrapid® Produced by the Current Process and Human Insulin With the Same Formulation as Actrapid®, Produced by the NN729 Process
This trial is conducted in Europe. The aim of this trial is to show that the product of the new production process has a similar pharmacological profile to the traditional process used for the current commercial product Actrapid®.
- Being tested
- human insulin
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human insulinDrug
Single dose of 0.2 IU/kg, administered subcutaneously (under the skin)
| Study group | Role | What they receive |
|---|---|---|
| NN729 manufacturing process | Experimental | Not described Receives: Drug: human insulin |
| Current manufacturing process | Active comparator | Not described Receives: Drug: human insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC (area under the curve) 0-8h (human insulin)
Cmax (maximum plasma concentration)
Area under the curve (glucose infusion rate (GIR)), 0-8h
Secondary outcomes (6)
tmax (time to reach maximum)
t½ (terminal half-life)
GIR (glucose infusion rate) max
tGIR (glucose infusion rate) max
Area under the curve (C-peptide, 0-8h)
Physical examinations and vital signs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study start15 Oct 2002
- Primary completion20 Dec 2002
- Study completion20 Dec 2002
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 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
- NCT01448070
- Sponsor's protocol ID
- NN729-1511
- Status last verified
- Feb 2017
- First submitted
- 5 Oct 2011
- 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
- A Single Centre, Randomized, Balanced Double Blind, Cross-over Trial Investigating the Bioequivalence of Actrapid® Produced by the Current Process and Human Insulin With the Same Formulation as Actrapid®, Produced by the NN729 Process
- ClinicalTrials.gov ID
- NCT01448070
- Acronym / sponsor ID
- NN729-1511
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2002 (actual)
- Primary completion
- 20 Dec 2002 (actual)
- Study completion
- 20 Dec 2002 (actual)
- First posted
- 7 Oct 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. The aim of this trial is to show that the product of the new production process has a similar pharmacological profile to the traditional process used for the current commercial product Actrapid®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NN729 manufacturing process | Experimental | Drug: human insulin |
| Current manufacturing process | Active comparator | Drug: human insulin |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant
- Fasting blood glucose below or equal to 6 mmol/L
- Body Mass Index (BMI) 22.0-27.0 kg/m^2 (both inclusive)
Key exclusion criteria (4 listed)
- Participated in another clinical study with an investigational drug within the last 4 weeks
- Any condition requiring the regular use of any medication, including herbal remedies, over the counter medicines and vitamins. Occasional paracetamol is acceptable
- Known or suspected allergy to the trial product or related products
- Family history of type 1 diabetes
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 insulinSingle dose of 0.2 IU/kg, administered subcutaneously (under the skin) | Drug | Current manufacturing process, NN729 manufacturing process |
Primary outcome
AUC (area under the curve) 0-8h (human insulin)
Cmax (maximum plasma concentration)
Area under the curve (glucose infusion rate (GIR)), 0-8h
6 secondary outcomes
tmax (time to reach maximum)
t½ (terminal half-life)
GIR (glucose infusion rate) max
tGIR (glucose infusion rate) max
Area under the curve (C-peptide, 0-8h)
Physical examinations and vital signs
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing human insulin in people with Diabetes and Healthy, run by Novo Nordisk A/S at 1 site in United Kingdom.
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 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 1 site in United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
AUC (area under the curve) 0-8h (human insulin). The study lists 3 primary outcomes in all. 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.