DelfaGLP-1 Atlas

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CompletedPhase 1

Investigating the Influence of Oral Semaglutide on Pharmacokinetics of Metformin and Digoxin in Healthy Subjects

An Open-label, Single Arm, Sequential, Single Centre Trial Investigating the Influence of Oral Semaglutide on Pharmacokinetics of Metformin and Digoxin in Healthy Subjects

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

32

actual

Study population

Healthy volunteers

Key I/E criterion

•BMI 20-29.9

Primary endpoints

•AUC of metformin•AUC of digoxin

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 IDNCT02249910
Org study IDNN9924-4145
Secondary ID2013-004820-12
Secondary IDU1111-1150-0801WHO

Timeline

Milestones

Study start2014-09-18actual
Study first posted2014-09-26estimated
Primary completion2015-03-06actual
Study completion2015-03-06actual
Last update posted2020-02-17actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Male or female, age 18-75 years (both inclusive) at the time of signing inform consent
•Body mass index (BMI) 20.0-29.9 kg/m^2 (both inclusive)
•A good general health based on medical history, physical examination, and results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator

Exclusion criteria

•Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods. Female of child bearing potential must use effective methods of birth control for the duration of the trial and for 5 weeks following last dose. Only highly effective methods of birth control are accepted (i.e., one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices)
•History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
•Hypertension (defined as sitting systolic blood pressure above 140 mmHg and/or diastolic blood pressure above 90 mmHg). If white-coat hypertension is suspected at the screening visit a repeated measurement is allowed
•Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening

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

Area under the metformin plasma concentration-time curve

Time frame:During a dosing interval (0 to12 hours) at steady state

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Area under the digoxin plasma concentration-time curve

Time frame:From time 0 to infinity after single dose

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum observed metformin plasma concentration

Time frame:During a dosing interval (0 to 12 hours) at steady state

Cmax

concentration, descriptive

Secondary/protocol endpoint

Maximum observed digoxin plasma concentration

Time frame:0 to 120 hours after single dose

Cmax

concentration, descriptive

Secondary/protocol endpoint

Maximum observed semaglutide plasma concentration

Time frame:During a dosing interval (0 to 24 hours) at steady state

Cmax

concentration, descriptive

Secondary/protocol endpoint

Area under the SNAC plasma concentration-time curve

Time frame:During a dosing interval (0 to 24 hours) at steady state

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Number of hypoglycaemic episodes

Time frame:From the first dosing (Day 1) and until completion of the post treatment follow up visit (Day 118-122)

Documented hypoglycemia

event count, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.