GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

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

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

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 19-24•Healthy volunteers

Primary endpoints

•AUC of insulin degludec•AUC of liraglutide

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03292185

Org study IDNN9068-4139

Secondary IDU1111-1155-0990World Health Organization (WHO)

Timeline

Milestones

Study first posted2017-09-25actual

Study start2017-09-29actual

Primary completion2018-01-02actual

Study completion2018-01-02actual

Last update posted2019-11-18actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (13)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

13 endpoints

Primary/protocol endpoint

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

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

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

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Area under the serum insulin degludec concentration time curve from 0 to infinity after single dose

Time frame:0 hours to 120 hours

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum observed serum insulin degludec concentration

Time frame:0 hours to 120 hours

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Time to maximum serum insulin degludec concentration

Time frame:0 hours to 120 hours

Tmax

descriptive

Secondary/protocol endpoint

Terminal elimination half-life for insulin degludec

Time frame:0 hours to 120 hours

Half-life

descriptive

Secondary/protocol endpoint

Area under the plasma liraglutide concentration time curve from 0 to infinity after single dose

Time frame:0 hours to 72 hours

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum observed plasma liraglutide concentration

Time frame:0 hours to 72 hours

Cmax

concentration, descriptive

Secondary/protocol endpoint

Time to maximum plasma liraglutide concentration

Time frame:0 hours to 72 hours

Tmax

descriptive

Secondary/protocol endpoint

Terminal elimination half-life of liraglutide

Time frame:0 hours to 72 hours

Half-life

descriptive

Secondary/protocol endpoint

Number of treatment emergent adverse events

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

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of treatment emergent hypoglycaemic episodes

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

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Local tolerability at the injection site

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

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.