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Completed

NCT Number: NCT03292185

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, 100032, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 thigh.

insulin degludec

Drug

17 U Insulin Degludec, single dose administration under the skin in the thigh.

liraglutide

Drug

0.6 mg Liraglutide, single dose administration under the skin in the thigh

Primary outcomes

  1. Area under the serum insulin degludec concentration time curve

    Time frame: From 0 to last quantifiable observation after single dose of insulin degludec/liraglutide and insulin degludec, assessments from 0 hours to 120 hours

    Calculated based on insulin degludec concentration in serum

  2. Area under the plasma liraglutide concentration time curve

    Time frame: from 0 to last quantifiable observation after single dose of insulin degludec/liraglutide and liraglutide, assessments from 0 hours to 72 hours

    Calculated based on liraglutide concentration in plasma

Secondary outcomes

  1. Area under the serum 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 serum

  2. Maximum observed serum insulin degludec concentration

    Time frame: 0 hours to 120 hours

    Calculated based on insulin degludec measured in serum

  3. Time to maximum serum insulin degludec concentration

    Time frame: 0 hours to 120 hours

    Calculated based on insulin degludec measured in serum

  4. Terminal elimination half-life for insulin degludec

    Time frame: 0 hours to 120 hours

    Calculated based on insulin degludec measured in serum

  5. 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

  6. Maximum observed plasma liraglutide concentration

    Time frame: 0 hours to 72 hours

    Calculated based on liraglutide measured in plasma

  7. Time to maximum plasma liraglutide concentration

    Time frame: 0 hours to 72 hours

    Calculated based on liraglutide measured in plasma

  8. Terminal elimination half-life of liraglutide

    Time frame: 0 hours to 72 hours

    Calculated based on liraglutide measured in plasma

  9. Number of treatment emergent adverse events

    Time frame: Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)

    Count

  10. Number of treatment emergent hypoglycaemic episodes

    Time frame: Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)

    Count

  11. Local tolerability at the injection site

    Time frame: Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)

    Count

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 25, 2017
Registry last updated
Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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