DiabetesPhase 1NCT01868581
Bioequivalence Between Two Explorative Insulin Degludec Formulations and Between Two Explorative IDegAsp Formulations in Healthy Subjects
A Phase 1 study testing insulin degludec and insulin degludec/insulin aspart in people with Diabetes and Healthy, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This trial is conducted i Europe. The aim of this trial is to test for bioequivalence between two explorative formulations of insulin degludec (insulin 454) and between two explorative insulin degludec/insulin aspart (IDegAsp - formerly SIAC) formulations, all with or without buffer, in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- What is being tested?
- insulin degludec and insulin degludec/insulin aspart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteGermany
- Study dates
- May 2008to Aug 2008
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent obtained before any trial-related activities. Trial related activities are any procedure that would not have been performed during the normal management of the subject
- Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
- Body mass index (BMI) between 18.0 and 27.0 kg/m^2 (inclusive)
- Fasting plasma glucose below or equal to 6 mmol/L
- Sexually active and non-sterilised participants must be informed that they and their partner must use a safe method of contraception during sexual intercourse (risk of pregnancy must be lower than 1%), e.g. implants, injections, combined oral contraceptives or hormonal intrauterinedevice or be willing to refrain from having sexual intercourse from the beginning of the study until up to three months after the conclusion of the study. This serves to exclude the possibilityof a pregnancy through sperm that could have been damaged by the study medication
Who cannot join
- A history of any illness that, in the opinion of the investigator, might confound the results of the trial or pose risk in administering the trial product to the subject
- Known or suspected allergy to trial products or related products
- Subject who has participated in any other trials involving investigational products within the last 3 months prior to first dosing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Single Centre, Double-blind, Two-period Crossover, Glucose Clamp Trial to Test for Bioequivalence Between Two Insulin 454 Formulations, With or Without Buffer, and Between Two SIAC Formulations, With or Without Buffer, in Healthy Male Subjects
This trial is conducted i Europe. The aim of this trial is to test for bioequivalence between two explorative formulations of insulin degludec (insulin 454) and between two explorative insulin degludec/insulin aspart (IDegAsp - formerly SIAC) formulations, all with or without buffer, in healthy male subjects. The investigated formulations are explorative, not similar to the proposed commercial formulation.
- Being tested
- insulin degludec, insulin degludec/insulin aspart
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin degludecDrug
Each subject will be allocated to 2 single injections of trial product on 2 separate dosing visits, administered subcutaneously (s.c., under the skin).
insulin degludec/insulin aspartDrug
Each subject will be allocated to 2 single injections of trial product on 2 separate dosing visits, administered subcutaneously (s.c., under the skin).
| Study group | Role | What they receive |
|---|---|---|
| insulin degludec | Experimental | Not described Receives: Drug: insulin degludec |
| IDegAsp | Experimental | Not described Receives: Drug: insulin degludec/insulin aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the serum insulin degludec concentration-time curve (for insulin degludec)
Measured: 0-120 hours after dosing
Maximum serum insulin degludec concentration (Cmax) (for insulin degludec)
Measured: 0-120 hours after dosing
Area under the serum insulin aspart concentration-time curve (for IDegAsp)
Measured: 0-10 hours after dosing
Maximum serum insulin aspart concentration (Cmax) (for IDegAsp)
Measured: 0-10 hours after dosing
Area under the serum insulin degludec concentration-time curve (for IDegAsp)
Measured: 0-120 hours after dosing
Maximum serum insulin degludec concentration (Cmax) (for IDegAsp)
Measured: 0-120 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startMay 2008
- Primary completionAug 2008
- Study completionAug 2008
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
- 58 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
- NCT01868581
- Sponsor's protocol ID
- NN5401-1985
- Other IDs
- 2008-000097-20, 2008
- Status last verified
- Oct 2015
- First submitted
- 30 May 2013
- Last updated
- 26 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Single Centre, Double-blind, Two-period Crossover, Glucose Clamp Trial to Test for Bioequivalence Between Two Insulin 454 Formulations, With or Without Buffer, and Between Two SIAC Formulations, With or Without Buffer, in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01868581
- Acronym / sponsor ID
- NN5401-1985
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 4 Jun 2013 (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 i Europe. The aim of this trial is to test for bioequivalence between two explorative formulations of insulin degludec (insulin 454) and between two explorative insulin degludec/insulin aspart (IDegAsp - formerly SIAC) formulations, all with or without buffer, in healthy male subjects. The investigated formulations are explorative, not similar to the proposed commercial formulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| insulin degludec | Experimental | Drug: insulin degludec |
| IDegAsp | Experimental | Drug: insulin degludec/insulin aspart |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Informed consent obtained before any trial-related activities. Trial related activities are any procedure that would not have been performed during the normal management of the subject
- Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
- Body mass index (BMI) between 18.0 and 27.0 kg/m^2 (inclusive)
- Fasting plasma glucose below or equal to 6 mmol/L
- Sexually active and non-sterilised participants must be informed that they and their partner must use a safe method of contraception during sexual intercourse (risk of pregnancy must be lower than 1%), e.g. implants, injections, combined oral contraceptives or hormonal intrauterinedevice or be willing to refrain from having sexual intercourse from the beginning of the study until up to three months after the conclusion of the study. This serves to exclude the possibilityof a pregnancy through sperm that could have been damaged by the study medication
Key exclusion criteria (3 listed)
- A history of any illness that, in the opinion of the investigator, might confound the results of the trial or pose risk in administering the trial product to the subject
- Known or suspected allergy to trial products or related products
- Subject who has participated in any other trials involving investigational products within the last 3 months prior to first dosing
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 degludecEach subject will be allocated to 2 single injections of trial product on 2 separate dosing visits, administered subcutaneously (s.c., under the skin). | Drug | insulin degludec |
| insulin degludec/insulin aspartEach subject will be allocated to 2 single injections of trial product on 2 separate dosing visits, administered subcutaneously (s.c., under the skin). | Drug | IDegAsp |
Primary outcome
Area under the serum insulin degludec concentration-time curve (for insulin degludec)
Time frame: 0-120 hours after dosing
Maximum serum insulin degludec concentration (Cmax) (for insulin degludec)
Time frame: 0-120 hours after dosing
Area under the serum insulin aspart concentration-time curve (for IDegAsp)
Time frame: 0-10 hours after dosing
Maximum serum insulin aspart concentration (Cmax) (for IDegAsp)
Time frame: 0-10 hours after dosing
Area under the serum insulin degludec concentration-time curve (for IDegAsp)
Time frame: 0-120 hours after dosing
Maximum serum insulin degludec concentration (Cmax) (for IDegAsp)
Time frame: 0-120 hours after dosing
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 26 Oct 2015.
- 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 insulin degludec and insulin degludec/insulin aspart in people with Diabetes and Healthy, run by Novo Nordisk A/S at 1 site in Germany.
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 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 26 Oct 2015. 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 Germany. 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 serum insulin degludec concentration-time curve (for insulin degludec) (time frame: 0-120 hours after dosing). The study lists 6 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 26 Oct 2015.