DiabetesPhase 1NCT01620450
Comparison of Insulin Aspart Produced by Current Process and the NN2000 Process in Healthy Japanese
A Phase 1 study testing biphasic human insulin 30 in people with Diabetes and Healthy, run by Novo Nordisk A/S at 1 site in Japan.
Trial summary
This trial is conducted in Japan. The aim of this trial is to compare insulin aspart produced by current process and the NN2000 process in healthy Japanese subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- What is being tested?
- biphasic human insulin 30
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteJapan
- Study dates
- 20 Nov 2004to 26 Feb 2005
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Japanese
- Considered generally healthy based on medical history and physical examination
- Body Mass Index (BMI) between 18 and 27 kg/m^2 (both inclusive)
- Fasting plasma glucose between 3.8 mmol/L (68.4 mg/dL) and 6.0 mmol/L (108.0 mg/dL)
Who cannot join
- Clinically significant abnormal values in clinical laboratory tests of haematology, biochemistry, fasting plasma glucose and urinalysis
- Any serious systemic infectious disease that occurred during the last 4 weeks before trial
- Any inter-current illness that may affect blood glucose
- Subject with a first degree relative with diabetes mellitus
- Blood donation of more than 400 mL (inclusive) in total within the last 12 weeks or more than 200 mL (inclusive) in total within the last 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-centre, Randomised, Double Blind, Cross-over Trial Demonstrating the Bioequivalence Between NN2000-Mix30 and NN-X14Mix30 (NovoRapid® 30 Mix) in Healthy Japanese Subjects
This trial is conducted in Japan. The aim of this trial is to compare insulin aspart produced by current process and the NN2000 process in healthy Japanese subjects.
- Being tested
- biphasic human insulin 30
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biphasic human insulin 30Drug
Single dose of each formulation administered subcutaneously (s.c., under the skin) on two separate visits
| Study group | Role | What they receive |
|---|---|---|
| NN2000 | Experimental | Not described Receives: Drug: biphasic human insulin 30 |
| NN-X14 | Active comparator | Not described Receives: Drug: biphasic human insulin 30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve of insulin aspart concentration (AUC IAsp, 0-16h)
Measured: From 0 to 16 hours after injection
Maximum insulin aspart concentration (Cmax IAsp)
Secondary outcomes (5)
Area under the curve of insulin aspart concentration (AUC IAsp)
Time to maximum insulin aspart concentration (tmax IAsp)
Terminal elimination half life (t½)
Body weight
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study start20 Nov 2004
- Primary completion26 Feb 2005
- Study completion26 Feb 2005
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
- 34 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
- NCT01620450
- Sponsor's protocol ID
- NN2000-1612
- Status last verified
- Feb 2017
- First submitted
- 13 Jun 2012
- 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 Single-centre, Randomised, Double Blind, Cross-over Trial Demonstrating the Bioequivalence Between NN2000-Mix30 and NN-X14Mix30 (NovoRapid® 30 Mix) in Healthy Japanese Subjects
- ClinicalTrials.gov ID
- NCT01620450
- Acronym / sponsor ID
- NN2000-1612
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2004 (actual)
- Primary completion
- 26 Feb 2005 (actual)
- Study completion
- 26 Feb 2005 (actual)
- First posted
- 15 Jun 2012 (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 Japan. The aim of this trial is to compare insulin aspart produced by current process and the NN2000 process in healthy Japanese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NN2000 | Experimental | Drug: biphasic human insulin 30 |
| NN-X14 | Active comparator | Drug: biphasic human insulin 30 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Japanese
- Considered generally healthy based on medical history and physical examination
- Body Mass Index (BMI) between 18 and 27 kg/m^2 (both inclusive)
- Fasting plasma glucose between 3.8 mmol/L (68.4 mg/dL) and 6.0 mmol/L (108.0 mg/dL)
Key exclusion criteria (5 listed)
- Clinically significant abnormal values in clinical laboratory tests of haematology, biochemistry, fasting plasma glucose and urinalysis
- Any serious systemic infectious disease that occurred during the last 4 weeks before trial
- Any inter-current illness that may affect blood glucose
- Subject with a first degree relative with diabetes mellitus
- Blood donation of more than 400 mL (inclusive) in total within the last 12 weeks or more than 200 mL (inclusive) in total within the last 4 weeks
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 |
|---|---|---|
| biphasic human insulin 30Single dose of each formulation administered subcutaneously (s.c., under the skin) on two separate visits | Drug | NN-X14, NN2000 |
Primary outcome
Area under the curve of insulin aspart concentration (AUC IAsp, 0-16h)
Time frame: From 0 to 16 hours after injection
Maximum insulin aspart concentration (Cmax IAsp)
5 secondary outcomes
Area under the curve of insulin aspart concentration (AUC IAsp)
Time to maximum insulin aspart concentration (tmax IAsp)
Terminal elimination half life (t½)
Body weight
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 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
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 biphasic human insulin 30 in people with Diabetes and Healthy, run by Novo Nordisk A/S at 1 site in Japan.
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 5 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 1 site in Japan. 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?
Area under the curve of insulin aspart concentration (AUC IAsp, 0-16h) (time frame: From 0 to 16 hours after injection). The study lists 2 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 1 Mar 2017.