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

NCT06449703 | Recruiting Phase 1

• 1 other identifier: THDB0213L01
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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®. 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

Outcome Measures

Primary Outcomes (6)

• Maximum observed plasma insulin degludec concentration

  Calculated based on insulin degludec measured in plasma

  0 hours to 120 hours

• Maximum observed plasma liraglutide concentration

  Calculated based on liraglutide measured in plasma

  0 hours to 72 hours

• Area under the plasma insulin degludec concentration time curve

  Calculated based on insulin degludec concentration in plasma

  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

  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

  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

  0 hours to 72 hours

Secondary Outcomes (12)

• Time to maximum plasma insulin degludec concentration

  0 hours to 120 hours

• Time to maximum plasma liraglutide concentration

  0 hours to 72 hours

• Terminal elimination half-life for insulin degludec

  0 hours to 120 hours

• Terminal elimination half-life for liraglutide

  0 hours to 72 hours

• Apparent clearance for insulin degludec

  0 hours to 120 hours

Study Arms (2)

Insulin Degludec/Liraglutide

EXPERIMENTAL

Drug: insulin degludec/liraglutide

Xultophy®

ACTIVE COMPARATOR

Drug: Xultophy®

Interventions

insulin degludec/liraglutide DRUG

Insulin Degludec/Liraglutide combination product with 0.61 mg Liraglutide and 17 U Insulin Degludec, single dose administration under the skin in the abdomen.

Insulin Degludec/Liraglutide

Xultophy® DRUG

Xultophy®

Xultophy®

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Tonghua Dongbao Pharmaceutical Co.,Ltd: lead

Study Sites (1)

the First Hospital of Jilin University

Jilin, China

RECRUITING

MeSH Terms

Interventions

IDegLira; Xultophy

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2024
• First Posted: June 10, 2024
• Study Start: May 6, 2024
• Primary Completion: June 16, 2024
• Study Completion: June 16, 2024
• Last Updated: June 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)