GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT01916174

CompletedPhase 1

A Trial to Demonstrate Bioequivalence Between Two Insulin Degludec/Liraglutide Formulations, B5 and V2 in Healthy 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 18.5-27•Healthy volunteers

Primary endpoints

•AUC of IDeg after single dose•Maximum observed serum IDeg concentration after single dose•AUC of liraglutide after single dose

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 IDNCT01916174

Org study IDNN9068-4026

Secondary ID2012-005468-93

Secondary IDU1111-1137-3809WHO

Timeline

Milestones

Study first posted2013-08-05estimated

Last update posted2013-11-08estimated

Study start2013-08 (month precision)

Primary completion2013-11actual (month precision)

Study completion2013-11actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Healthy male and female volunteers

•Body mass index (BMI) between 18.5 and 27.0 kg/m^2 (both inclusive)

•Body weight between 60 and 90 kg (both inclusive)

Exclusion criteria

•Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods. Adequate contraceptive measures are implants, injectables, combined oral contraceptives, hormonal intrauterine device, sexual abstinence or vasectomised partner

•History or presence of cancer, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrine (incl. diabetes), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders

•Use of any prescription or non-prescription medication, except for paracetamol, acetylsalicylic acid, contraceptives and vitamins (but including mega-dose vitamin therapy, as judged by the investigator) within 2 weeks before the trial

•Drug or alcohol abuse

Endpoints (10)

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

10 endpoints

Primary/protocol endpoint

Area under the serum IDeg concentration time curve after single dose

Time frame:Assessed from 0 to 120 hours

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Maximum observed serum IDeg concentration after single dose

Time frame:Assessed from 0-120 hours

Cmax

concentration, descriptive

Primary/protocol endpoint

Area under the plasma liraglutide concentration time curve after single dose

Time frame:Assessed from 0-72 hours

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Maximum observed plasma liraglutide concentration after single dose

Time frame:Assessed from 0-72 hours

Cmax

concentration, descriptive

Secondary/protocol endpoint

Area under the serum IDeg concentration time curve after single dose

Time frame:Assessed from 0-120 hours

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Time to maximum IDeg concentration

Time frame:Assessed from 0-120 hours

Tmax

descriptive

Secondary/protocol endpoint

Terminal elimination half-life for IDeg after single dose

Time frame:Assessed from 0-120 hours

Half-life

descriptive

Secondary/protocol endpoint

Area under the plasma liraglutide concentration time curve after single dose

Time frame:Assessed from 0-72 hours

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Time to maximum plasma liraglutide concentration after single dose

Time frame:Assessed from 0-72 hours

Tmax

descriptive

Secondary/protocol endpoint

Terminal elimination half-life of liraglutide after single dose

Time frame:Assessed from 0-72 hours

Half-life

descriptive

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.