Clinical trial NCT03292185: A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2017-09-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Three-period complete cross-over, six treatment sequences
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Area under the serum insulin degludec concentration time curve
timeFrame: From 0 to last quantifiable observation after single dose of insulin degludec/liraglutide and insulin degludec, assessments from 0 hours to 120 hours
measure: Area under the plasma liraglutide concentration time curve
timeFrame: from 0 to last quantifiable observation after single dose of insulin degludec/liraglutide and liraglutide, assessments from 0 hours to 72 hours
Secondary outcomes:
measure: Area under the serum insulin degludec concentration time curve from 0 to infinity after single dose
timeFrame: 0 hours to 120 hours
measure: Maximum observed serum insulin degludec concentration
timeFrame: 0 hours to 120 hours
measure: Time to maximum serum insulin degludec concentration
timeFrame: 0 hours to 120 hours
measure: Terminal elimination half-life for insulin degludec
timeFrame: 0 hours to 120 hours
measure: Area under the plasma liraglutide concentration time curve from 0 to infinity after single dose
timeFrame: 0 hours to 72 hours
measure: Maximum observed plasma liraglutide concentration
timeFrame: 0 hours to 72 hours
measure: Time to maximum plasma liraglutide concentration
timeFrame: 0 hours to 72 hours
measure: Terminal elimination half-life of liraglutide
timeFrame: 0 hours to 72 hours
measure: Number of treatment emergent adverse events
timeFrame: Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)
measure: Number of treatment emergent hypoglycaemic episodes
timeFrame: Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)
measure: Local tolerability at the injection site
timeFrame: Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
Study officials:
References: