A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide in Healthy Chinese Subjects

Launched by TONGHUA DONGBAO PHARMACEUTICAL CO.,LTD · Jun 5, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating how a combination of two medications, insulin degludec and liraglutide, behave in the body when given as a single dose. The goal is to understand how these medications work together compared to a similar product called Xultophy. The study will involve healthy Chinese participants aged 18 to 45, and will require them to provide blood samples at different times to measure the levels of these medications in their bodies. Participants will stay at the study site for some days and visit on other days for drug administration and check-ups.

To be eligible for this trial, participants must not have any major health issues, must not be pregnant or planning to become pregnant, and must be willing to follow specific guidelines during the study. Overall, participants can expect to undergo a thorough screening process, provide some blood samples (less than 400 mL total), and spend a few days at the study site while receiving the medications. It’s important to note that individuals with certain medical histories or conditions will not be able to participate, as the study aims to ensure everyone's safety.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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;
• • 2. Subjects are able to communicate well with the investigator and complete the study;
• • 3. 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;
• • 4. Healthy Chinese subjects aged 18 to 45 years (inclusive), male or female;
• • 5. Body Mass Index (BMI) ≥ 19 kg/m2 and ≤ 26kg/m2 at screening, male weight ≥ 50 kg, females weight≥ 45 kg;
• • 6. Fasting blood glucose \< 6.1 mmol/L at screening;
• • 7. Normal or abnormal but not clinically significant physical examination and vital signs at screening.
• Exclusion Criteria:
• Subjects who meet any of the following criteria will be excluded from the study:
• • 1. 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;
• • 2. 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;
• • 3. Females breast-feeding, or females with a positive blood pregnancy test result at screening;
• • 4. 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;
• • 5. 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;
• • 6. 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;
• • 7. 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;
• • 8. A history of diabetes mellitus in the past;
• • 9. A personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2;
• • 10. A history of pancreatitis (acute or chronic) in the past;
• • 11. 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;
• • 12. Abnormal and clinically significant 12-Lead ECG;
• • 13. Abnormal and clinically significant calcitonin test at screening;
• • 14. Positive for any of human immunodeficiency virus (HIV) antibody, hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCVAb) or treponema pallidum antibody;
• • 15. 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;
• • 16. A history of smoking (average daily smoking\>5 cigarettes) within 3 months prior to screening and cannot quit during the study;
• • 17. 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;
• • 18. 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;
• • 19. 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;
• • 20. Individuals who have received any GLP-1 drug within 3 months prior to screening;
• • 21. Individuals who have received any vaccination within 1 month prior to screening, or plan to receive any vaccination during the study;
• • 22. Individuals who still need or plan to engage in strenuous physical activities or exercise during participation in the study;
• • 23. Any other factor not suitable for participation in this clinical study as judged by the investigator.