GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT01319240

CompletedPhase 1

Safety and Tolerability of Insulin Degludec/Liraglutide (A3) in Healthy Subjects

A Trial to Investigate Pharmacokinetics, Safety and Tolerability of Insulin Degludec/Liraglutide (A3) Compared With Insulin Degludec and Liraglutide 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 20-27•Male

Primary endpoints

•Area under insulin degludec concentration-time curve•Area under liraglutide concentration-time curve

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 IDNCT01319240

Org study IDNN9068-3871

Secondary ID2010-021190-36

Secondary IDU1111-1119-2417WHO

Timeline

Milestones

Study first posted2011-03-21estimated

Last update posted2015-10-02estimated

Study start2011-03 (month precision)

Primary completion2011-05actual (month precision)

Study completion2011-05actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexMale

Healthy volunteersNot accepted

Inclusion criteria

•Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)

•Body Mass Index (BMI) between 20.0 and 27.0 kg/m^2 (both inclusive)

•Body weight between 75 kg and 90 kg (both inclusive)

•Fasting plasma glucose below 6.1 mmol/L (110 mg/dL)

Exclusion criteria

•Known or suspected hypersensitivity to trial products or related products

•Previous participation in this trial. Participation is defined as randomised

•Previous participation in any other clinical trial involving other investigational products within the last 3 months before dosing in this trial

•Donation of any blood or plasma in the past month or in excess of 500 mL within the 3 month preceding screening (trial start) or surgery or trauma with more than 500 mL blood loss within the 3 month preceding screening

•History of or presence of cancer, or any clinically significant cardiovascular, respiratory,metabolic, renal, hepatic, gastrointestinal, endocrine, diabetes, haematological, dermatological,venereal, neurological, psychiatric diseases or other major disorders that might have impact on the trial, as judged by the Investigator (Trial Physician)

•Clinically significant abnormal haematology, biochemistry, lipids, urinalysis or coagulation screening tests, as judged by the Investigator (Trial Physician)

•Known hepatitis or known carrier of the hepatitis B surface antigen (HBsAg) or hepatitis C antibodies, or a positive result to the test for HIV (human immunodeficiency virus) antibodies and antigen

•Family or personal history of MEN2 (Multiple endocrine neoplasia syndrome type 2) or familial medullary thyroid carcinoma (FMTC)

•History of chronic pancreatitis or idiopathic acute pancreatitis

•Supine blood pressure at screening, after resting for 5 min, outside the range of 90-140 mmHg systolic or 50-90 mmHg diastolic (excluding white-coat hypertension; therefore, if a repeated measurement on a second screening visit shows values within the range, the subject can be included in the trial) or resting heart rate outside the range of 40-90 bpm

•Clinically significant abnormal ECG (Electrocardiogram) at screening (trial start)

•Significant history of alcoholism or drug/chemical abuse, or a positive result of the urine drug screen or alcohol breath test, or consuming more than 21 units of alcohol per week (one unit of alcohol equals about 250 mL of beer or lager, one glass of wine, or 20 mL spirits)

•Smoking more than 5 cigarettes, or the equivalent, per day and unable to refrain from smoking during the in-house periods

•Mental incapacity or language barriers which preclude adequate understanding or cooperation,unwillingness to participate in the trial or subjects that in the opinion of Investigator (trial physician) should not participate in the trial

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

•Any condition that would interfere with trial participation or evaluation of results, as judged by the Investigator (trial physician)

•Subjects with a history of deep leg vein thrombosis or with frequent appearance of deep leg vein thrombosis in 1st degree relatives as judged by the Investigator (trial physician)

•Males who are sexually active and not surgically sterilised, who or whose partner are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)

•Baseline (screening) calcitonin level above or equal to 50 ng/L

•Suffer from a life threatening disease

Endpoints (7)

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

7 endpoints

Primary/protocol endpoint

The area under insulin degludec concentration-time curve

Time frame:from 0-infinity hours after trial product administration

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

The area under liraglutide concentration-time curve

Time frame:from 0-infinity hours after trial product administration

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

The area under insulin degludec concentration-time curve

Time frame:from 0-120 hours after trial product administration

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

The area under liraglutide concentration-time curve

Time frame:from 0-72 hours after trial product administration

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum concentration of insulin degludec

Time frame:from 0-120 hours after trial product administration

Cmax

concentration, descriptive

Secondary/protocol endpoint

Maximum concentration of liraglutide

Time frame:from 0-72 hours after trial product administration

Cmax

concentration, descriptive

Secondary/protocol endpoint

Number of hypoglycaemic episodes

Time frame:From day 0 to 7-14 days after 3rd trial product administration

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.