DiabetesPhase 1NCT01916174
A Trial to Demonstrate Bioequivalence Between Two Insulin Degludec/Liraglutide Formulations, B5 and V2 in Healthy Subjects
A Phase 1 study testing insulin degludec/liraglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This trial is conducted in Europe. The aim of this trial is to assess the expected biological equivalence between two formulations of insulin degludec/liraglutide (IDegLira) with identical active ingredient in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2, Healthy
- What is being tested?
- insulin degludec/liraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2013to Nov 2013
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female volunteers
- Body mass index (BMI) between 18.5 and 27.0 kg/m^2 (both inclusive)
- Body weight between 60 and 90 kg (both inclusive)
Who cannot join
- Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods. Adequate contraceptive measures are implants, injectables, combined oral contraceptives, hormonal intrauterine device, sexual abstinence or vasectomised partner
- History or presence of cancer, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrine (incl. diabetes), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders
- Use of any prescription or non-prescription medication, except for paracetamol, acetylsalicylic acid, contraceptives and vitamins (but including mega-dose vitamin therapy, as judged by the investigator) within 2 weeks before the trial
- Drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
About this study
This trial is conducted in Europe. The aim of this trial is to assess the expected biological equivalence between two formulations of insulin degludec/liraglutide (IDegLira) with identical active ingredient in healthy volunteers.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Healthy
- Being tested
- insulin degludec/liraglutide
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin degludec/liraglutideDrug
Subject will receive a single injection (s.c.) of IDegLira B5
insulin degludec/liraglutideDrug
Subject will receive a single injection (s.c.) of IDegLira V2
| Study group | Role | What they receive |
|---|---|---|
| Insulin degludec/liraglutide, B5 | Experimental | Subjects will be randomly allocated to the two single dose administrations (one for each of the two IDegLira formulations) on the two separate dosing visits. The two administration days will be separated by a wash-out period of 7-15 days. Receives: Drug: insulin degludec/liraglutide |
| Insulin degludec/liraglutide, V2 | Experimental | Subjects will be randomly allocated to the two single dose administrations (one for each of the two IDegLira formulations) on the two separate dosing visits. The two administration days will be separated by a wash-out period of 7-15 days. Receives: Drug: insulin degludec/liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the serum IDeg concentration time curve after single dose
Measured: Assessed from 0 to 120 hours
Maximum observed serum IDeg concentration after single dose
Measured: Assessed from 0-120 hours
Area under the plasma liraglutide concentration time curve after single dose
Measured: Assessed from 0-72 hours
Maximum observed plasma liraglutide concentration after single dose
Measured: Assessed from 0-72 hours
Secondary outcomes (6)
Area under the serum IDeg concentration time curve after single dose
Measured: Assessed from 0-120 hours
Time to maximum IDeg concentration
Measured: Assessed from 0-120 hours
Terminal elimination half-life for IDeg after single dose
Measured: Assessed from 0-120 hours
Area under the plasma liraglutide concentration time curve after single dose
Measured: Assessed from 0-72 hours
Time to maximum plasma liraglutide concentration after single dose
Measured: Assessed from 0-72 hours
Terminal elimination half-life of liraglutide after single dose
Measured: Assessed from 0-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionNov 2013
- Study completionNov 2013
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
- 50 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
- NCT01916174
- Sponsor's protocol ID
- NN9068-4026
- Other IDs
- 2012-005468-93, U1111-1137-3809
- Status last verified
- Nov 2013
- First submitted
- 2 Aug 2013
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Demonstrate Bioequivalence Between Two Insulin Degludec/Liraglutide Formulations, B5 and V2 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01916174
- Acronym / sponsor ID
- NN9068-4026
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 5 Aug 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 in Europe. The aim of this trial is to assess the expected biological equivalence between two formulations of insulin degludec/liraglutide (IDegLira) with identical active ingredient in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin degludec/liraglutide, B5 | Experimental | Drug: insulin degludec/liraglutideSubjects will be randomly allocated to the two single dose administrations (one for each of the two IDegLira formulations) on the two separate dosing visits. The two administration days will be separated by a wash-out period of 7-15 days. |
| Insulin degludec/liraglutide, V2 | Experimental | Drug: insulin degludec/liraglutideSubjects will be randomly allocated to the two single dose administrations (one for each of the two IDegLira formulations) on the two separate dosing visits. The two administration days will be separated by a wash-out period of 7-15 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and female volunteers
- Body mass index (BMI) between 18.5 and 27.0 kg/m^2 (both inclusive)
- Body weight between 60 and 90 kg (both inclusive)
Key exclusion criteria (4 listed)
- Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods. Adequate contraceptive measures are implants, injectables, combined oral contraceptives, hormonal intrauterine device, sexual abstinence or vasectomised partner
- History or presence of cancer, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrine (incl. diabetes), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders
- Use of any prescription or non-prescription medication, except for paracetamol, acetylsalicylic acid, contraceptives and vitamins (but including mega-dose vitamin therapy, as judged by the investigator) within 2 weeks before the trial
- Drug or alcohol abuse
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 degludec/liraglutideSubject will receive a single injection (s.c.) of IDegLira B5 | Drug | Insulin degludec/liraglutide, B5 |
| insulin degludec/liraglutideSubject will receive a single injection (s.c.) of IDegLira V2 | Drug | Insulin degludec/liraglutide, V2 |
Primary outcome
Area under the serum IDeg concentration time curve after single dose
Time frame: Assessed from 0 to 120 hours
Maximum observed serum IDeg concentration after single dose
Time frame: Assessed from 0-120 hours
Area under the plasma liraglutide concentration time curve after single dose
Time frame: Assessed from 0-72 hours
Maximum observed plasma liraglutide concentration after single dose
Time frame: Assessed from 0-72 hours
6 secondary outcomes
Area under the serum IDeg concentration time curve after single dose
Time frame: Assessed from 0-120 hours
Time to maximum IDeg concentration
Time frame: Assessed from 0-120 hours
Terminal elimination half-life for IDeg after single dose
Time frame: Assessed from 0-120 hours
Area under the plasma liraglutide concentration time curve after single dose
Time frame: Assessed from 0-72 hours
Time to maximum plasma liraglutide concentration after single dose
Time frame: Assessed from 0-72 hours
Terminal elimination half-life of liraglutide after single dose
Time frame: Assessed from 0-72 hours
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 8 Nov 2013.
- 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/liraglutide in people with Diabetes and Diabetes Mellitus, Type 2, 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 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 8 Nov 2013. 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 IDeg concentration time curve after single dose (time frame: Assessed from 0 to 120 hours). The study lists 4 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 8 Nov 2013.