DelfaGLP-1 Atlas

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CompletedPhase 1

A Research Study to Look at How Insulin Icodec and Semaglutide Work in the Body of People From China With Type 2 Diabetes When Given Alone or Together

A Study Investigating the Pharmacokinetic Properties of a Single Dose of IcoSema Compared With Insulin Icodec and Semaglutide Given Separately in Chinese Participants With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

20

actual

Study population

Type 2 diabetes

Key I/E criterion

•BMI 18.5-34.9

Primary endpoints

•AUC of insulin icodec after a single dose•Dose-normalised AUCSema,0-tz

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 IDNCT05435677
Org study IDNN1535-4710
Secondary IDU1111-1262-1959World Health Organization (WHO)

Timeline

Milestones

Study start2022-06-22actual
Study first posted2022-06-28actual
Primary completion2023-04-25actual
Study completion2023-04-25actual
Last update posted2025-03-21actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age64 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Chinese male or female
•Aged 18-64 years (both inclusive) at the time of signing informed consent
•Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the day of screening
•Body mass index between 18.5 and 34.9 kg/m^2 (both inclusive)
•Body weight greater than or equal to 50 kg
•HbA1c (glycated haemoglobin) below or equal to 9.0% (75 mmol/mol)
•Insulin naïve. However, short-term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes
•Stable daily dose(s) including any of the following anti-diabetic drug(s)/regimen within 45 days prior to the day of screening:
–Any metformin formulation
–DPP-4 (dipeptidyl peptidase-4) inhibitors (participants are not allowed to participate in the study if they are treated with DPP-4 inhibitors as monotherapy)
–SGLT2 (sodium-glucose linked transporter 2) inhibitors
–Alpha-glucosidase inhibitors
–Oral combination products (for the allowed individual oral antidiabetic drugs)

Exclusion criteria

•Known or suspected hypersensitivity to trial product(s) or related products
•Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive method
•Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
•Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within the past 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within the past 180 days prior to the day of screening

Endpoints (11)

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

11 endpoints
Primary/protocol endpoint

AUCIco,0-tz:Area under the serum insulin icodec concentration-time curve after a single dose

Time frame:From 0 hours to tz hours after IMP administration (day 1) where tz is the time of the last quantifiable concentration

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Dose-normalised AUCSema,0-tz: Area under the plasma semaglutide concentration-time curve after a single dose divided by dose

Time frame:From 0 hours to tz hours after IMP administration (day 1) where tz is the time of the last quantifiable concentration

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

AUCIco,0-inf: Area under the serum insulin icodec concentration-time curve after a single dose

Time frame:From 0 hours to infinity after IMP administration (day 1)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,Ico: Maximum observed serum insulin icodec concentration after a single dose

Time frame:From 0 hours until last measurement time after IMP administration (day 1)

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax,Ico: Time to maximum observed serum insulin icodec concentration after a single dose

Time frame:From 0 hours until last measurement time after IMP administration (day 1)

Tmax

descriptive

Secondary/protocol endpoint

t1/2,Ico: Terminal half-life for insulin icodec after a single dose

Time frame:Terminal part of the serum insulin icodec concentration-time curve where the curve is well approximated by a straight line on logarithmic scale after IMP administration (day 1)

Half-life

descriptive

Secondary/protocol endpoint

Dose-normalised AUCSema,0-inf: Area under the plasma semaglutide concentration-time curve after a single dose divided by dose

Time frame:From 0 hours to infinity after IMP administration (day 1)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Dose-normalised Cmax,Sema: Maximum observed plasma semaglutide concentration after a single dose divided by dose

Time frame:From 0 hours until last measurement time after IMP administration (day 1)

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax,Sema: Time to maximum observed plasma semaglutide concentration after a single dose

Time frame:From 0 hours until last measurement time after IMP administration (day 1)

Tmax

descriptive

Secondary/protocol endpoint

t1/2,Sema: Terminal half-life for semaglutide after a single dose

Time frame:Terminal part of the plasma semaglutide concentration-time curve where the curve is well approximated by a straight line on logarithmic scale after IMP administration (day 1)

Half-life

descriptive

Secondary/protocol endpoint

Adverse events

Time frame:From IMP administration (day 1) to end of follow-up for each treatment period (day 36)

Treatment-emergent AEs (any)

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.