DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT03789578

CompletedPhase 1

A Research Study to Look at How Insulin 287 and Semaglutide Work in the Body of People With Type 2 Diabetes When Taken Alone or Together

A Trial to Investigate Single Dose Pharmacokinetics of NNC0148-0287sema in a Fixed Ratio Compared With Insulin 287 and Semaglutide Given Separately in Subjects With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

30

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 6-8.5%

Primary endpoints

•AUCI287, 0-tz, AUC of insulin 287 from 0 hours to last quantifiable observation•AUCSema,0-tz, AUC of semaglutide from 0 hours to last quantifiable observation

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 IDNCT03789578
Org study IDNN1535-4359
Secondary ID2017-004538-27European Medicines Agency (EudraCT)
Secondary IDU1111-1204-8233World Health Organization (WHO)

Timeline

Milestones

Study first posted2018-12-28actual
Study start2019-01-17actual
Primary completion2019-10-10actual
Study completion2019-10-10actual
Last update posted2024-11-12actual

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

•Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent
•Diagnosed with type 2 diabetes mellitus more than or equal to 180 days prior to the day of screening
•Body weight between 80.0 to 120.0 kg (both inclusive)
•Glycosylated haemoglobin (HbA1c) 6.0 to 8.5% (both inclusive)
•No current and no regular previous intake of insulin. Previous insulin treatment for short periods of time (a maximum of 14 days) is allowed, as well as insulin use during a previous period of gestational diabetes in the past (as declared by the subject or reported in the medical records)
•Stable daily dose(s) of the following anti-diabetic drug(s)/regimen within the past 90 days prior to the day of screening:
a)Any metformin formulation (dose as documented in the subject medical record),
b)One other oral antidiabetic drug (dose as documented in the subject medical record) is allowed, but not mandatory: Insulin secretagogue (sulphonylureas), dipeptidyl peptidase 4 (DPP-4) inhibitor and sodium glucose co-transporter 2 (SGLT2) inhibitor

Exclusion criteria

•Known or suspected hypersensitivity to trial products or related products
•Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods
•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
•Receipt of any investigational medicinal product within 90 days before screening
•History of severe allergies to drugs or foods or a history of severe anaphylactic reaction

Endpoints (22)

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

22 endpoints
Primary/protocol endpoint/low confidence

AUCI287, 0-tz, area under the serum insulin 287 concentration-time curve from 0 hours to last quantifiable observation after a single dose

Time frame:0-840 hours

concentration, descriptive

Primary/protocol endpoint

AUCSema,0-tz, area under the plasma semaglutide concentration-time curve from 0 hours to last quantifiable observation after a single dose

Time frame:0-840 hours

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

AUCI287,0-∞ area under the serum insulin 287 concentration-time curve from 0 hours to infinity after a single dose

Time frame:0-840 hours

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax, I287, maximum observed serum insulin 287 concentration after a single dose

Time frame:0-840 hours

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax, I287, time to maximum observed serum insulin 287 concentration after a single dose

Time frame:0-840 hours

Tmax

descriptive

Secondary/protocol endpoint

AUCSema,0-∞, area under the plasma semaglutide concentration-time curve from 0 hours to infinity after a single dose

Time frame:0-840 hours

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,Sema, maximum observed plasma semaglutide concentration after a single dose

Time frame:0-840 hours

Cmax

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:0-840 hours

Tmax

descriptive

Secondary/protocol endpoint

Number of treatment emergent adverse events

Time frame:Day 1 (beginning of each period) to day 36 (end of each period)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of hypoglycaemic episodes

Time frame:Day 1 (beginning of each period) to day 36 (end of each period)

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Antibodies for insulin 287: Change in anti-insulin 287 binding antibody levels

Time frame:Day -1 (pre-dose), Day 36 (end of period)

change from baseline, descriptive

Secondary/protocol endpoint

Antibodies for insulin 287: Occurrence of anti-insulin 287 binding antibodies

Time frame:Day 36 (end of period)

Immunogenicity (ADA)

categorical status, event

Secondary/protocol endpoint

Antibodies for insulin 287: Occurrence of anti-insulin 287 binding antibodies cross reacting to human insulin

Time frame:Day 36 (end of period)

Immunogenicity (ADA)

categorical status, event

Secondary/protocol endpoint

Antibodies for semaglutide: Change in anti-semaglutide binding antibody levels

Time frame:Day -1 (pre-dose), Day 36 (end of period)

Immunogenicity (ADA)

change from baseline, descriptive

Secondary/protocol endpoint

Antibodies for semaglutide: Occurrence of anti-semaglutide binding antibodies

Time frame:Day 36 (end of period)

Immunogenicity (ADA)

categorical status, event

Secondary/protocol endpoint

Antibodies for semaglutide: Occurrence of anti-semaglutide binding antibodies cross reacting to endogenous glucagon-like peptide-1 (GLP-1)

Time frame:Day 36 (end of period)

Immunogenicity (ADA)

categorical status, event

Secondary/protocol endpoint

Binding antibodies and in vitro neutralising antibodies (semaglutide only): Anti-semaglutide binding antibody levels

Time frame:Day 151 (follow-up/end-of-trial visit)

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-semaglutide binding antibodies cross reacting to endogenous GLP-1

Time frame:Day 151 (follow-up/end-of-trial visit)

Immunogenicity (ADA)

categorical status, event

Secondary/protocol endpoint

Binding antibodies and in vitro neutralising antibodies (semaglutide only): Anti-insulin 287 binding antibody levels

Time frame:Day 151 (follow-up/end-of-trial visit)

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-insulin 287 binding antibodies cross reacting to human insulin

Time frame:Day 151 (follow-up/end-of-trial visit)

Immunogenicity (ADA)

categorical status, event

Secondary/protocol endpoint

Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-semaglutide neutralising antibodies

Time frame:Day 151 (follow-up/end-of-trial visit)

Immunogenicity (ADA)

categorical status, event

Secondary/protocol endpoint

Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-semaglutide neutralising antibodies cross reacting with endogenous GLP-1

Time frame:Day 151 (follow-up/end-of-trial visit)

Immunogenicity (ADA)

categorical status, 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.