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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
insulin degludec/liraglutide
insulin degludec
liraglutide
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

IDeglira-IDeg-Liraglutide

IDeglira-Liraglutide-IDeg

IDeg-Liraglutide-IDeglira

IDeg-IDeglira-Liraglutide

Liraglutide-IDeg-IDeglira

Liraglutide-IDeglira-IDeg

Arm Description

Treatment sequence first Insulin Degludec/Liraglutide, then Insulin Degludec, then Liraglutide

Treatment sequence first Insulin Degludec/Liraglutide, then Liraglutide, then Insulin Degludec

Treatment sequence first Isulin Degludec, then Liraglutide, then Insulin Degludec/Liraglutide

Treatment sequence first Insulin Degludec, then Insulin Degludec/Liraglutide, then Liraglutide

Treatment sequence first Liraglutide, then Insulin Degludec, then Insulin Degludec/Liraglutide

Treatment sequence first Liraglutide, then Insulin Degludec/Liraglutide, then Insulin Degludec

Outcomes

Primary Outcome Measures

Area under the serum insulin degludec concentration time curve
Calculated based on insulin degludec concentration in serum
Area under the plasma liraglutide concentration time curve
Calculated based on liraglutide concentration in plasma

Secondary Outcome Measures

Area under the serum insulin degludec concentration time curve from 0 to infinity after single dose
Calculated based on insulin degludec measured in serum
Maximum observed serum insulin degludec concentration
Calculated based on insulin degludec measured in serum
Time to maximum serum insulin degludec concentration
Calculated based on insulin degludec measured in serum
Terminal elimination half-life for insulin degludec
Calculated based on insulin degludec measured in serum
Area under the plasma liraglutide concentration time curve from 0 to infinity after single dose
Calculated based on liraglutide measured in plasma
Maximum observed plasma liraglutide concentration
Calculated based on liraglutide measured in plasma
Time to maximum plasma liraglutide concentration
Calculated based on liraglutide measured in plasma
Terminal elimination half-life of liraglutide
Calculated based on liraglutide measured in plasma
Number of treatment emergent adverse events
Count
Number of treatment emergent hypoglycaemic episodes
Count
Local tolerability at the injection site
Count

Full Information

First Posted
September 19, 2017
Last Updated
November 15, 2019
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT03292185
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 29, 2017 (Actual)
Primary Completion Date
January 2, 2018 (Actual)
Study Completion Date
January 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
Three-period complete cross-over, six treatment sequences
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IDeglira-IDeg-Liraglutide
Arm Type
Experimental
Arm Description
Treatment sequence first Insulin Degludec/Liraglutide, then Insulin Degludec, then Liraglutide
Arm Title
IDeglira-Liraglutide-IDeg
Arm Type
Experimental
Arm Description
Treatment sequence first Insulin Degludec/Liraglutide, then Liraglutide, then Insulin Degludec
Arm Title
IDeg-Liraglutide-IDeglira
Arm Type
Experimental
Arm Description
Treatment sequence first Isulin Degludec, then Liraglutide, then Insulin Degludec/Liraglutide
Arm Title
IDeg-IDeglira-Liraglutide
Arm Type
Experimental
Arm Description
Treatment sequence first Insulin Degludec, then Insulin Degludec/Liraglutide, then Liraglutide
Arm Title
Liraglutide-IDeg-IDeglira
Arm Type
Experimental
Arm Description
Treatment sequence first Liraglutide, then Insulin Degludec, then Insulin Degludec/Liraglutide
Arm Title
Liraglutide-IDeglira-IDeg
Arm Type
Experimental
Arm Description
Treatment sequence first Liraglutide, then Insulin Degludec/Liraglutide, then Insulin Degludec
Intervention Type
Drug
Intervention Name(s)
insulin degludec/liraglutide
Intervention Description
Insulin Degludec/Liraglutide combination product with 0.61 mg Liraglutide and 17 U Insulin Degludec, single dose administration under the skin in the thigh.
Intervention Type
Drug
Intervention Name(s)
insulin degludec
Intervention Description
17 U Insulin Degludec, single dose administration under the skin in the thigh.
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
0.6 mg Liraglutide, single dose administration under the skin in the thigh
Primary Outcome Measure Information:
Title
Area under the serum insulin degludec concentration time curve
Description
Calculated based on insulin degludec concentration in serum
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
Title
Area under the plasma liraglutide concentration time curve
Description
Calculated based on liraglutide concentration in plasma
Time Frame
from 0 to last quantifiable observation after single dose of insulin degludec/liraglutide and liraglutide, assessments from 0 hours to 72 hours
Secondary Outcome Measure Information:
Title
Area under the serum insulin degludec concentration time curve from 0 to infinity after single dose
Description
Calculated based on insulin degludec measured in serum
Time Frame
0 hours to 120 hours
Title
Maximum observed serum insulin degludec concentration
Description
Calculated based on insulin degludec measured in serum
Time Frame
0 hours to 120 hours
Title
Time to maximum serum insulin degludec concentration
Description
Calculated based on insulin degludec measured in serum
Time Frame
0 hours to 120 hours
Title
Terminal elimination half-life for insulin degludec
Description
Calculated based on insulin degludec measured in serum
Time Frame
0 hours to 120 hours
Title
Area under the plasma liraglutide concentration time curve from 0 to infinity after single dose
Description
Calculated based on liraglutide measured in plasma
Time Frame
0 hours to 72 hours
Title
Maximum observed plasma liraglutide concentration
Description
Calculated based on liraglutide measured in plasma
Time Frame
0 hours to 72 hours
Title
Time to maximum plasma liraglutide concentration
Description
Calculated based on liraglutide measured in plasma
Time Frame
0 hours to 72 hours
Title
Terminal elimination half-life of liraglutide
Description
Calculated based on liraglutide measured in plasma
Time Frame
0 hours to 72 hours
Title
Number of treatment emergent adverse events
Description
Count
Time Frame
Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)
Title
Number of treatment emergent hypoglycaemic episodes
Description
Count
Time Frame
Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)
Title
Local tolerability at the injection site
Description
Count
Time Frame
Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Learn more about this trial

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

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