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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03292185
Recruitment Status : Completed
First Posted : September 25, 2017
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: insulin degludec/liraglutide Drug: insulin degludec Drug: liraglutide Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Three-period complete cross-over, six treatment sequences
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Primary Purpose: Treatment
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
Actual Study Start Date : September 29, 2017
Actual Primary Completion Date : January 2, 2018
Actual Study Completion Date : January 2, 2018


Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03292185


Locations
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China, Beijing
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100032
Sponsors and Collaborators
Novo Nordisk A/S
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03292185    
Other Study ID Numbers: NN9068-4139
U1111-1155-0990 ( Other Identifier: World Health Organization (WHO) )
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

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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
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Liraglutide
Insulin, Long-Acting
Xultophy
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists