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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03292185
• Other study ID #: NN9068-4139
• Secondary ID: U1111-1155-0990
• Status: Completed
• Phase: Phase 1
• Start date: September 29, 2017
• Est. completion date: January 2, 2018

Study information

• Verified date: November 2019
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2, 2018
• Est. primary completion date: January 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion criteria:

• 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)

Exclusion criteria:

• 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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin degludec/liraglutide
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 degludec
17 U Insulin Degludec, single dose administration under the skin in the thigh.
• liraglutide
0.6 mg Liraglutide, single dose administration under the skin in the thigh

Locations

Country	Name	City	State
China	Novo Nordisk Investigational Site	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the serum insulin degludec concentration time curve	Calculated based on insulin degludec concentration in serum	From 0 to last quantifiable observation after single dose of insulin degludec/liraglutide and insulin degludec, assessments from 0 hours to 120 hours
Primary	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 and liraglutide, assessments from 0 hours to 72 hours
Secondary	Area under the serum insulin degludec concentration time curve from 0 to infinity after single dose	Calculated based on insulin degludec measured in serum	0 hours to 120 hours
Secondary	Maximum observed serum insulin degludec concentration	Calculated based on insulin degludec measured in serum	0 hours to 120 hours
Secondary	Time to maximum serum insulin degludec concentration	Calculated based on insulin degludec measured in serum	0 hours to 120 hours
Secondary	Terminal elimination half-life for insulin degludec	Calculated based on insulin degludec measured in serum	0 hours to 120 hours
Secondary	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	Maximum observed plasma liraglutide concentration	Calculated based on liraglutide measured in plasma	0 hours to 72 hours
Secondary	Time to maximum plasma liraglutide concentration	Calculated based on liraglutide measured in plasma	0 hours to 72 hours
Secondary	Terminal elimination half-life of liraglutide	Calculated based on liraglutide measured in plasma	0 hours to 72 hours
Secondary	Number of treatment emergent adverse events	Count	Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)
Secondary	Number of treatment emergent hypoglycaemic episodes	Count	Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)
Secondary	Local tolerability at the injection site	Count	Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)