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

November 15, 2019 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100032
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: IDeglira-IDeg-Liraglutide
Treatment sequence first Insulin Degludec/Liraglutide, then Insulin Degludec, then Liraglutide
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.
Drug: insulin degludec
17 U Insulin Degludec, single dose administration under the skin in the thigh.
Drug: liraglutide
0.6 mg Liraglutide, single dose administration under the skin in the thigh
EXPERIMENTAL: IDeglira-Liraglutide-IDeg
Treatment sequence first Insulin Degludec/Liraglutide, then Liraglutide, then Insulin Degludec
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.
Drug: insulin degludec
17 U Insulin Degludec, single dose administration under the skin in the thigh.
Drug: liraglutide
0.6 mg Liraglutide, single dose administration under the skin in the thigh
EXPERIMENTAL: IDeg-Liraglutide-IDeglira
Treatment sequence first Isulin Degludec, then Liraglutide, then Insulin Degludec/Liraglutide
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.
Drug: insulin degludec
17 U Insulin Degludec, single dose administration under the skin in the thigh.
Drug: liraglutide
0.6 mg Liraglutide, single dose administration under the skin in the thigh
EXPERIMENTAL: IDeg-IDeglira-Liraglutide
Treatment sequence first Insulin Degludec, then Insulin Degludec/Liraglutide, then Liraglutide
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.
Drug: insulin degludec
17 U Insulin Degludec, single dose administration under the skin in the thigh.
Drug: liraglutide
0.6 mg Liraglutide, single dose administration under the skin in the thigh
EXPERIMENTAL: Liraglutide-IDeg-IDeglira
Treatment sequence first Liraglutide, then Insulin Degludec, then Insulin Degludec/Liraglutide
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.
Drug: insulin degludec
17 U Insulin Degludec, single dose administration under the skin in the thigh.
Drug: liraglutide
0.6 mg Liraglutide, single dose administration under the skin in the thigh
EXPERIMENTAL: Liraglutide-IDeglira-IDeg
Treatment sequence first Liraglutide, then Insulin Degludec/Liraglutide, then Insulin Degludec
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.
Drug: insulin degludec
17 U Insulin Degludec, single dose administration under the skin in the thigh.
Drug: liraglutide
0.6 mg Liraglutide, single dose administration under the skin in the thigh

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From 0 to last quantifiable observation after single dose of insulin degludec/liraglutide and insulin degludec, assessments from 0 hours to 120 hours
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
from 0 to last quantifiable observation after single dose of insulin degludec/liraglutide and liraglutide, assessments from 0 hours to 72 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
0 hours to 120 hours
Maximum observed serum insulin degludec concentration
Time Frame: 0 hours to 120 hours
Calculated based on insulin degludec measured in serum
0 hours to 120 hours
Time to maximum serum insulin degludec concentration
Time Frame: 0 hours to 120 hours
Calculated based on insulin degludec measured in serum
0 hours to 120 hours
Terminal elimination half-life for insulin degludec
Time Frame: 0 hours to 120 hours
Calculated based on insulin degludec measured in serum
0 hours to 120 hours
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
0 hours to 72 hours
Maximum observed plasma liraglutide concentration
Time Frame: 0 hours to 72 hours
Calculated based on liraglutide measured in plasma
0 hours to 72 hours
Time to maximum plasma liraglutide concentration
Time Frame: 0 hours to 72 hours
Calculated based on liraglutide measured in plasma
0 hours to 72 hours
Terminal elimination half-life of liraglutide
Time Frame: 0 hours to 72 hours
Calculated based on liraglutide measured in plasma
0 hours to 72 hours
Number of treatment emergent adverse events
Time Frame: Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)
Count
Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)
Number of treatment emergent hypoglycaemic episodes
Time Frame: Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)
Count
Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)
Local tolerability at the injection site
Time Frame: Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)
Count
Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 2, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 2, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN9068-4139
  • U1111-1155-0990 (OTHER: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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