DiabetesPhase 1NCT03292185
A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects
A Phase 1 study testing insulin degludec/liraglutide, insulin degludec and liraglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in China.
Trial summary
The main purpose of the trial is to compare the bioavailability (extent of drug absorption into the circulation) of insulin degludec and liraglutide as part of a combination product insulin degludec/liraglutide compared to the corresponding doses of single, separate injections of insulin degludec and liraglutide. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- insulin degludec/liraglutide, insulin degludec and liraglutide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 29 Sep 2017to 2 Jan 2018
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female Chinese subjects, who are considered to be generally healthy, based on assessment of medical history, physical examination, and clinical laboratory data, as judged by the investigator
- Age between 18 to 45 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) between 19.0 and 24.0 kg/sqm (both inclusive)
- Body weight at least 50.0 kg
- Fasting plasma glucose less than 6.1 mmol/L (110 mg/dL)
Who cannot join
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential not using an adequate contraceptive methods throughout the trial including follow-up period. Adequate contraceptive measures are sterilisation, intrauterine device (IUD), oral contraceptives or barrier methods
- Donation of any blood or plasma in the past month or in excess of 400 mL within the 90 days preceding screening or surgery or trauma with more than 400 mL blood loss within the 90 days preceding screening
- History or presence of cancer, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrine (incl. diabetes and recurrent hypoglycaemia), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders that might have impact on the trial result, as judged by the investigator
- Use of any prescription or non-prescription medication, except for paracetamol, acetylsalicylic acid, contraceptives and vitamins (mega-dose vitamin therapy not allowed, dose judged by the investigator) within 2 weeks prior to screening
Trial locations and contacts
1 site in 1 country.
China1 site
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100032
About this study
Official title: A Single Centre, Randomised, Double-blind, Three-period Cross-over Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects
The main purpose of the trial is to compare the bioavailability (extent of drug absorption into the circulation) of insulin degludec and liraglutide as part of a combination product insulin degludec/liraglutide compared to the corresponding doses of single, separate injections of insulin degludec and liraglutide. Participants will receive all three test substances. The order of trial administration will be allocated by chance. During the trial period, serials of blood samples will be collected from the participants at three dosing periods, in order to determine the concentration of insulin degludec and liraglutide. The total volume of blood taken throughout the whole trial period will be less than 400 mL. Participants will be asked to stay on daytime and overnight in the trial sites on some predefined days. For other outpatient days, participants need to attend the trial site as required for drug administration or required assessments.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- insulin degludec/liraglutide, 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
Insulin Degludec/Liraglutide combination product with 0.61 mg Liraglutide and 17 U Insulin Degludec, single dose administration under the skin in the thigh.
insulin degludecDrug
17 U Insulin Degludec, single dose administration under the skin in the thigh.
liraglutideDrug
0.6 mg Liraglutide, single dose administration under the skin in the thigh
| Study group | Role | What they receive |
|---|---|---|
| IDeglira-IDeg-Liraglutide | Experimental | Treatment sequence first Insulin Degludec/Liraglutide, then Insulin Degludec, then Liraglutide Receives: Drug: insulin degludec/liraglutide; Drug: insulin degludec; Drug: liraglutide |
| IDeglira-Liraglutide-IDeg | Experimental | Treatment sequence first Insulin Degludec/Liraglutide, then Liraglutide, then Insulin Degludec Receives: Drug: insulin degludec/liraglutide; Drug: insulin degludec; Drug: liraglutide |
| IDeg-Liraglutide-IDeglira | Experimental | Treatment sequence first Isulin Degludec, then Liraglutide, then Insulin Degludec/Liraglutide Receives: Drug: insulin degludec/liraglutide; Drug: insulin degludec; Drug: liraglutide |
| IDeg-IDeglira-Liraglutide | Experimental | Treatment sequence first Insulin Degludec, then Insulin Degludec/Liraglutide, then Liraglutide Receives: Drug: insulin degludec/liraglutide; Drug: insulin degludec; Drug: liraglutide |
| Liraglutide-IDeg-IDeglira | Experimental | Treatment sequence first Liraglutide, then Insulin Degludec, then Insulin Degludec/Liraglutide Receives: Drug: insulin degludec/liraglutide; Drug: insulin degludec; Drug: liraglutide |
| Liraglutide-IDeglira-IDeg | Experimental | Treatment sequence first Liraglutide, then Insulin Degludec/Liraglutide, then Insulin Degludec Receives: Drug: insulin degludec/liraglutide; Drug: insulin degludec; Drug: liraglutide |
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
Calculated based on insulin degludec concentration in serum
Measured: From 0 to last quantifiable observation after single dose of insulin degludec/liraglutide and insulin degludec, assessments from 0 hours to 120 hours
Area under the plasma liraglutide concentration time curve
Calculated based on liraglutide concentration in plasma
Measured: from 0 to last quantifiable observation after single dose of insulin degludec/liraglutide and liraglutide, assessments from 0 hours to 72 hours
Secondary outcomes (11)
Area under the serum insulin degludec concentration time curve from 0 to infinity after single dose
Calculated based on insulin degludec measured in serum
Measured: 0 hours to 120 hours
Maximum observed serum insulin degludec concentration
Calculated based on insulin degludec measured in serum
Measured: 0 hours to 120 hours
Time to maximum serum insulin degludec concentration
Calculated based on insulin degludec measured in serum
Measured: 0 hours to 120 hours
Terminal elimination half-life for insulin degludec
Calculated based on insulin degludec measured in serum
Measured: 0 hours to 120 hours
Area under the plasma liraglutide concentration time curve from 0 to infinity after single dose
Calculated based on liraglutide measured in plasma
Measured: 0 hours to 72 hours
Maximum observed plasma liraglutide concentration
Calculated based on liraglutide measured in plasma
Measured: 0 hours to 72 hours
Time to maximum plasma liraglutide concentration
Calculated based on liraglutide measured in plasma
Measured: 0 hours to 72 hours
Terminal elimination half-life of liraglutide
Calculated based on liraglutide measured in plasma
Measured: 0 hours to 72 hours
Number of treatment emergent adverse events
Count
Measured: Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)
Number of treatment emergent hypoglycaemic episodes
Count
Measured: Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)
Local tolerability at the injection site
Count
Measured: Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start29 Sep 2017
- Primary completion2 Jan 2018
- Study completion2 Jan 2018
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
- Model description
- Three-period complete cross-over, six treatment sequences
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292185
- Sponsor's protocol ID
- NN9068-4139
- Other IDs
- U1111-1155-0990
- Status last verified
- Nov 2019
- First submitted
- 19 Sep 2017
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre, Randomised, Double-blind, Three-period Cross-over Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT03292185
- Acronym / sponsor ID
- NN9068-4139
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 2 Jan 2018 (actual)
- Study completion
- 2 Jan 2018 (actual)
- First posted
- 25 Sep 2017 (actual)
- 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.
The main purpose of the trial is to compare the bioavailability (extent of drug absorption into the circulation) of insulin degludec and liraglutide as part of a combination product insulin degludec/liraglutide compared to the corresponding doses of single, separate injections of insulin degludec and liraglutide. Participants will receive all three test substances. The order of trial administration will be allocated by chance. During the trial period, serials of blood samples will be collected from the participants at three dosing periods, in order to determine the concentration of insulin degludec and liraglutide. The total volume of blood taken throughout the whole trial period will be less than 400 mL. Participants will be asked to stay on daytime and overnight in the trial sites on some predefined days. For other outpatient days, participants need to attend the trial site as required for drug administration or required assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Three-period complete cross-over, six treatment sequences
| Arm | Type | Receives |
|---|---|---|
| IDeglira-IDeg-Liraglutide | Experimental | Drug: insulin degludec/liraglutide, Drug: insulin degludec, Drug: liraglutideTreatment sequence first Insulin Degludec/Liraglutide, then Insulin Degludec, then Liraglutide |
| IDeglira-Liraglutide-IDeg | Experimental | Drug: insulin degludec/liraglutide, Drug: insulin degludec, Drug: liraglutideTreatment sequence first Insulin Degludec/Liraglutide, then Liraglutide, then Insulin Degludec |
| IDeg-Liraglutide-IDeglira | Experimental | Drug: insulin degludec/liraglutide, Drug: insulin degludec, Drug: liraglutideTreatment sequence first Isulin Degludec, then Liraglutide, then Insulin Degludec/Liraglutide |
| IDeg-IDeglira-Liraglutide | Experimental | Drug: insulin degludec/liraglutide, Drug: insulin degludec, Drug: liraglutideTreatment sequence first Insulin Degludec, then Insulin Degludec/Liraglutide, then Liraglutide |
| Liraglutide-IDeg-IDeglira | Experimental | Drug: insulin degludec/liraglutide, Drug: insulin degludec, Drug: liraglutideTreatment sequence first Liraglutide, then Insulin Degludec, then Insulin Degludec/Liraglutide |
| Liraglutide-IDeglira-IDeg | Experimental | Drug: insulin degludec/liraglutide, Drug: insulin degludec, Drug: liraglutideTreatment sequence first Liraglutide, then Insulin Degludec/Liraglutide, then Insulin Degludec |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and female Chinese subjects, who are considered to be generally healthy, based on assessment of medical history, physical examination, and clinical laboratory data, as judged by the investigator
- Age between 18 to 45 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) between 19.0 and 24.0 kg/sqm (both inclusive)
- Body weight at least 50.0 kg
- Fasting plasma glucose less than 6.1 mmol/L (110 mg/dL)
Key exclusion criteria (4 listed)
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential not using an adequate contraceptive methods throughout the trial including follow-up period. Adequate contraceptive measures are sterilisation, intrauterine device (IUD), oral contraceptives or barrier methods
- Donation of any blood or plasma in the past month or in excess of 400 mL within the 90 days preceding screening or surgery or trauma with more than 400 mL blood loss within the 90 days preceding screening
- History or presence of cancer, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrine (incl. diabetes and recurrent hypoglycaemia), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders that might have impact on the trial result, as judged by the investigator
- Use of any prescription or non-prescription medication, except for paracetamol, acetylsalicylic acid, contraceptives and vitamins (mega-dose vitamin therapy not allowed, dose judged by the investigator) within 2 weeks prior to screening
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/liraglutideInsulin Degludec/Liraglutide combination product with 0.61 mg Liraglutide and 17 U Insulin Degludec, single dose administration under the skin in the thigh. | Drug | IDeg-IDeglira-Liraglutide, IDeg-Liraglutide-IDeglira, IDeglira-IDeg-Liraglutide, IDeglira-Liraglutide-IDeg, Liraglutide-IDeg-IDeglira, Liraglutide-IDeglira-IDeg |
| insulin degludec17 U Insulin Degludec, single dose administration under the skin in the thigh. | Drug | IDeg-IDeglira-Liraglutide, IDeg-Liraglutide-IDeglira, IDeglira-IDeg-Liraglutide, IDeglira-Liraglutide-IDeg, Liraglutide-IDeg-IDeglira, Liraglutide-IDeglira-IDeg |
| liraglutide0.6 mg Liraglutide, single dose administration under the skin in the thigh | Drug | IDeg-IDeglira-Liraglutide, IDeg-Liraglutide-IDeglira, IDeglira-IDeg-Liraglutide, IDeglira-Liraglutide-IDeg, Liraglutide-IDeg-IDeglira, Liraglutide-IDeglira-IDeg |
Primary outcome
Area under the serum insulin degludec concentration time curve
Time frame: From 0 to last quantifiable observation after single dose of insulin degludec/liraglutide and insulin degludec, assessments from 0 hours to 120 hours
Calculated based on insulin degludec concentration in serum
Area under the plasma liraglutide concentration time curve
Time frame: from 0 to last quantifiable observation after single dose of insulin degludec/liraglutide and liraglutide, assessments from 0 hours to 72 hours
Calculated based on liraglutide concentration in plasma
11 secondary outcomes
Area under the serum insulin degludec concentration time curve from 0 to infinity after single dose
Time frame: 0 hours to 120 hours
Maximum observed serum insulin degludec concentration
Time frame: 0 hours to 120 hours
Time to maximum serum insulin degludec concentration
Time frame: 0 hours to 120 hours
Terminal elimination half-life for insulin degludec
Time frame: 0 hours to 120 hours
Area under the plasma liraglutide concentration time curve from 0 to infinity after single dose
Time frame: 0 hours to 72 hours
Maximum observed plasma liraglutide concentration
Time frame: 0 hours to 72 hours
Time to maximum plasma liraglutide concentration
Time frame: 0 hours to 72 hours
Terminal elimination half-life of liraglutide
Time frame: 0 hours to 72 hours
Number of treatment emergent adverse events
Time frame: Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)
Number of treatment emergent hypoglycaemic episodes
Time frame: Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)
Local tolerability at the injection site
Time frame: Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)
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 18 Nov 2019.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, insulin degludec and liraglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in China.
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 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 18 Nov 2019. 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 China. 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 (time frame: From 0 to last quantifiable observation after single dose of insulin degludec/liraglutide and insulin degludec, assessments from 0 hours to 120 hours). 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 18 Nov 2019.