HealthyPhase 1NCT06449703
A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide in Healthy Chinese Subjects
A Phase 1 study testing insulin degludec/liraglutide and Xultophy® in people with Healthy, run by Tonghua Dongbao Pharmaceutical Co.,Ltd at 1 site in China.
Trial summary
The main purpose of the trial is to compare the pharmacokinetics of insulin degludec and liraglutide as part of a combination product insulin degludec/liraglutide compared with Xultophy®. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- insulin degludec/liraglutide and Xultophy®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2024to 16 Jun 2024
- 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
- Subjects signed and dated Informed consent form (ICF) before having a full understanding of the study contents and procedures and potential adverse reactions for the study;
- Subjects are able to communicate well with the investigator and complete the study;
- Subjects (including partners) have no pregnancy plan and voluntarily take effective contraceptive measures (For details of the contraceptive measures, see Appendix II) from screening to within 6 months after the last dose of study drug;
- Healthy Chinese subjects aged 18 to 45 years (inclusive), male or female;
- Body Mass Index (BMI) ≥ 19 kg/m2 and ≤ 26kg/m2 at screening, male weight ≥ 50 kg, females weight≥ 45 kg;
- Fasting blood glucose < 6.1 mmol/L at screening;
- Normal or abnormal but not clinically significant physical examination and vital signs at screening.
Who cannot join
- Subjects who meet any of the following criteria will be excluded from the study:
- A history of allergy to the ingredients of investigational medical product or other glucagon-like peptide-1 (GLP-1) analogues and their excipients, or a history of severe drug or food allergy;
- A history of fainting during acupuncture treatment and blood phobia and physical condition unable to withstand blood collection, poor vein condition leading to infeasibility of establishment of blood collection pathway, and difficulty in venous blood collection;
- Females breast-feeding, or females with a positive blood pregnancy test result at screening;
- Individuals who have participated in clinical trials of drugs or medical devices within 3 months prior to screening, defined as whose who have used other investigational products or devices;
- Individuals who have undergone surgery within 3 months prior to screening, which may affect the safety of subjects or the evaluation of the study results as judged by the investigator, or those who have undergone surgery within 1 month prior to screening or plan to undergo surgery during the study;
Show all 24Show fewer
- Donated > 400 mL of blood or donated any blood component or had a total blood loss of > 400 mL for any reason within 3 months prior to screening, or those who have a history of blood transfusion, use of blood products or who cannot guarantee not donating whole blood or blood components (e.g., plasma, platelets) during the study or within 30 days after the end of the study;
- Abnormal and clinically significant clinical laboratory test results, or with the following clinically significant diseases as indicated by other clinical findings within 12 months prior to screening, including but not limited to circulatory, digestion, respiratory, endocrine, urinary, nervous, blood and immune system disorders or psychiatric disorders;
- A history of diabetes mellitus in the past;
- A personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2;
- A history of pancreatitis (acute or chronic) in the past;
- Thrombotic diseases in the past (e.g., with a medical history of pulmonary embolism and deep venous thrombosis or superficial vein thrombosis not cured or cured within 6 months prior to enrollment) or currently with new thrombotic diseases or using anticoagulants;
- Abnormal and clinically significant 12-Lead ECG;
- Abnormal and clinically significant calcitonin test at screening;
- Positive for any of human immunodeficiency virus (HIV) antibody, hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCVAb) or treponema pallidum antibody;
- A history of drug abuse in the past 5 years or have engaged in drug taking or been tested positive for breath alcohol test or urine drug screening within 3 months prior to screening;
- A history of smoking (average daily smoking>5 cigarettes) within 3 months prior to screening and cannot quit during the study;
- In the three months before screening, the intake of alcohol more than 14 units every week (1 unit ≈ 360 mL of beer, 45 mL of spirits with alcohol content ≥ 40% or 150 mL of wine) and cannot quit during the study;
- Those who drink excessive amounts of tea, coffee and/or caffeinated beverages (over 8 cups, with 1 cup ≈ 250 mL) every day within 3 months prior to screening and cannot quit during the study;
- Individuals who have used any prescription drug, non-prescription drug (except for occasional or restrictive use of paracetamol), health product (except for conventional vitamin supplements and calcium) within 14 days prior to screening, or those who have used any traditional herb containing unknown or unspecified components within 3 months prior to screening;
- Individuals who have received any GLP-1 drug within 3 months prior to screening;
- Individuals who have received any vaccination within 1 month prior to screening, or plan to receive any vaccination during the study;
- Individuals who still need or plan to engage in strenuous physical activities or exercise during participation in the study;
- Any other factor not suitable for participation in this clinical study as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Hospital of Jilin University
Jilin City
Xiaojiao Li, 13514314089, xingxingsuo123456@126.com
About this study
Official title: A Randomized, Open-label, Two-period, Cross-over Trial to Evaluate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Injection Compared With Xultophy® in Healthy Chinese Subjects
The main purpose of the trial is to compare the pharmacokinetics of insulin degludec and liraglutide as part of a combination product insulin degludec/liraglutide compared with Xultophy®. During the trial period, serials of blood samples will be collected from the participants at two 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
- Healthy
- Being tested
- insulin degludec/liraglutide, Xultophy®
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 abdomen.
Xultophy®Drug
Xultophy®
| Study group | Role | What they receive |
|---|---|---|
| Insulin Degludec/Liraglutide | Experimental | Not described Receives: Drug: insulin degludec/liraglutide |
| Xultophy® | Active comparator | Not described Receives: Drug: Xultophy® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma insulin degludec concentration
Calculated based on insulin degludec measured in plasma
Measured: 0 hours to 120 hours
Maximum observed plasma liraglutide concentration
Calculated based on liraglutide measured in plasma
Measured: 0 hours to 72 hours
Area under the plasma insulin degludec concentration time curve
Calculated based on insulin degludec concentration in plasma
Measured: From 0 to last quantifiable observation after single dose of insulin degludec/liraglutide, 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, assessments from 0 hours to 72 hours
Area under the plasma insulin degludec concentration time curve from 0 to infinity after single dose
Calculated based on insulin degludec measured in plasma
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
Secondary outcomes (12)
Time to maximum plasma insulin degludec concentration
Calculated based on insulin degludec measured in plasma
Measured: 0 hours to 120 hours
Time to maximum plasma liraglutide concentration
Calculated based on liraglutide measured in plasma
Measured: 0 hours to 72 hours
Terminal elimination half-life for insulin degludec
Calculated based on insulin degludec measured in plasma
Measured: 0 hours to 120 hours
Terminal elimination half-life for liraglutide
Calculated based on liraglutide measured in plasma
Measured: 0 hours to 72 hours
Apparent clearance for insulin degludec
Calculated based on insulin degludec measured in plasma
Measured: 0 hours to 120 hours
Apparent clearance for liraglutide
Calculated based on liraglutide measured in plasma
Measured: 0 hours to 72 hours
Apparent volume of distribution for insulin degludec
Calculated based on insulin degludec measured in plasma
Measured: 0 hours to 120 hours
Apparent volume of distribution for liraglutide
Calculated based on liraglutide measured in plasma
Measured: 0 hours to 72 hours
Area under the plasma insulin degludec concentration time curve
Calculated based on insulin degludec concentration in plasma
Measured: 0 hours to 24 hours
Number of treatment emergent adverse events
Count
Measured: From the first drug administration to the follow-up visit (6 to 13 days after the last drug administration)
Number of treatment emergent hypoglycaemic episodes
Count
Measured: From the first drug administration to the follow-up visit (6 to 13 days after the last drug administration)
Number of participants with injection site reactions (spontaneous pain, tenderness, itching, redness, edema, induration/infiltration)
Count
Measured: From the first drug administration to the follow-up visit (6 to 13 days after the last drug administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start6 May 2024
- Primary completion16 Jun 2024 (estimated)
- Study completion16 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tonghua Dongbao Pharmaceutical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449703
- Sponsor's protocol ID
- THDB0213L01
- Status last verified
- May 2024
- First submitted
- 2 Jun 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Two-period, Cross-over Trial to Evaluate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Injection Compared With Xultophy® in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT06449703
- Acronym / sponsor ID
- THDB0213L01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Tonghua Dongbao Pharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 6 May 2024 (actual)
- Primary completion
- 16 Jun 2024 (estimated)
- Study completion
- 16 Jun 2024 (estimated)
- First posted
- 10 Jun 2024 (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 pharmacokinetics of insulin degludec and liraglutide as part of a combination product insulin degludec/liraglutide compared with Xultophy®. During the trial period, serials of blood samples will be collected from the participants at two 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
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin Degludec/Liraglutide | Experimental | Drug: insulin degludec/liraglutide |
| Xultophy® | Active comparator | Drug: Xultophy® |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects signed and dated Informed consent form (ICF) before having a full understanding of the study contents and procedures and potential adverse reactions for the study;
- Subjects are able to communicate well with the investigator and complete the study;
- Subjects (including partners) have no pregnancy plan and voluntarily take effective contraceptive measures (For details of the contraceptive measures, see Appendix II) from screening to within 6 months after the last dose of study drug;
- Healthy Chinese subjects aged 18 to 45 years (inclusive), male or female;
- Body Mass Index (BMI) ≥ 19 kg/m2 and ≤ 26kg/m2 at screening, male weight ≥ 50 kg, females weight≥ 45 kg;
Key exclusion criteria (24 listed)
- A history of allergy to the ingredients of investigational medical product or other glucagon-like peptide-1 (GLP-1) analogues and their excipients, or a history of severe drug or food allergy;
- A history of fainting during acupuncture treatment and blood phobia and physical condition unable to withstand blood collection, poor vein condition leading to infeasibility of establishment of blood collection pathway, and difficulty in venous blood collection;
- Females breast-feeding, or females with a positive blood pregnancy test result at screening;
- Individuals who have participated in clinical trials of drugs or medical devices within 3 months prior to screening, defined as whose who have used other investigational products or devices;
- Individuals who have undergone surgery within 3 months prior to screening, which may affect the safety of subjects or the evaluation of the study results as judged by the investigator, or those who have undergone surgery within 1 month prior to screening or plan to undergo surgery during the study;
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 abdomen. | Drug | Insulin Degludec/Liraglutide |
| Xultophy®Xultophy® | Drug | Xultophy® |
Primary outcome
Maximum observed plasma insulin degludec concentration
Time frame: 0 hours to 120 hours
Calculated based on insulin degludec measured in plasma
Maximum observed plasma liraglutide concentration
Time frame: 0 hours to 72 hours
Calculated based on liraglutide measured in plasma
Area under the plasma insulin degludec concentration time curve
Time frame: From 0 to last quantifiable observation after single dose of insulin degludec/liraglutide, assessments from 0 hours to 120 hours
Calculated based on insulin degludec concentration in plasma
Area under the plasma liraglutide concentration time curve
Time frame: From 0 to last quantifiable observation after single dose of insulin degludec/liraglutide, assessments from 0 hours to 72 hours
Calculated based on liraglutide concentration in plasma
Area under the plasma insulin degludec concentration time curve from 0 to infinity after single dose
Time frame: 0 hours to 120 hours
Calculated based on insulin degludec measured in plasma
Area under the plasma liraglutide concentration time curve from 0 to infinity after single dose
Time frame: 0 hours to 72 hours
Calculated based on liraglutide measured in plasma
12 secondary outcomes
Time to maximum plasma insulin degludec concentration
Time frame: 0 hours to 120 hours
Time to maximum plasma liraglutide concentration
Time frame: 0 hours to 72 hours
Terminal elimination half-life for insulin degludec
Time frame: 0 hours to 120 hours
Terminal elimination half-life for liraglutide
Time frame: 0 hours to 72 hours
Apparent clearance for insulin degludec
Time frame: 0 hours to 120 hours
Apparent clearance for liraglutide
Time frame: 0 hours to 72 hours
Apparent volume of distribution for insulin degludec
Time frame: 0 hours to 120 hours
Apparent volume of distribution for liraglutide
Time frame: 0 hours to 72 hours
Area under the plasma insulin degludec concentration time curve
Time frame: 0 hours to 24 hours
Number of treatment emergent adverse events
Time frame: From the first drug administration to the follow-up visit (6 to 13 days after the last drug administration)
Number of treatment emergent hypoglycaemic episodes
Time frame: From the first drug administration to the follow-up visit (6 to 13 days after the last drug administration)
Number of participants with injection site reactions (spontaneous pain, tenderness, itching, redness, edema, induration/infiltration)
Time frame: From the first drug administration to the follow-up visit (6 to 13 days after the last drug administration)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Individual participant dataSharing planned: No
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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.
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 and Xultophy® in people with Healthy, run by Tonghua Dongbao Pharmaceutical Co.,Ltd 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 7 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 10 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed plasma insulin degludec concentration (time frame: 0 hours to 120 hours). 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 10 Jun 2024.