DelfaGLP-1 Atlas

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CompletedPhase 1

A Trial Investigating the Effect of Oral Semaglutide Compared With Placebo on Postprandial Glucose and Triglyceride Metabolism, Energy Intake, Appetite Sensations and Gastric Emptying in Subjects With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

15

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 20-38•HbA1c 6-9%

Primary endpoint

•AUC of glucose

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 IDNCT02773381
Org study IDNN9924-4248
Secondary ID2015-003998-14
Secondary IDU1111-1174-1070WHO

Timeline

Milestones

Study first posted2016-05-16estimated
Study start2016-06-02actual
Primary completion2018-10-19actual
Study completion2018-10-19actual
Last update posted2020-12-08actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent
•Subjects diagnosed with type 2 diabetes mellitus for at least 90 days prior to the day of screening.
•Treated with diet and exercise and/or metformin monotherapy. The metformin dose should be unchanged in a period of 30 days prior to screening
•Body mass index (BMI) between 20.0-38 kg/m^2 (both inclusive)
•HbA1c (glycosylated haemoglobin) between 6.0-9.0 % (both inclusive)

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 (adequate contraceptive measures as required by local regulation or practice)
•Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroids Carcinoma
•History of pancreatitis (acute or chronic)
•Presence of clinically significant or symptoms of gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator
•History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
•History or presence of any clinically relevant respiratory, metabolic (including dyslipedimia, however mild dyslipidaemia, defined as screening total cholesterol below or equal to 7.8 mmol/L and screening triglyceride below or equal to 3.42 mmol/L is accepted), renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with diabetes mellitus)
•History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas)
•History or presence of cardiovascular disease including stable and unstable angina, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias and conduction disorders
•Renal impairment with estimated Glomerular Filtration Rate (eGFR) below 60 mL /min as defined by CKD-EPI using IDMS for serum creatinine measurement on the day of screening
•Impaired liver function, defined as ALT above or equal to 2.5 times upper normal limit (UNL) on the day of screening
•Smoker (defined as a subject who is smoking more than 1 cigarette or the equivalent per day). During the in-patient period, the subject must be willing to completely refrain from smoking and use of nicotine substitute products
•Known or suspected alcohol abuse within 1 year from screening (defined as regular intake of more than 21 units weekly for men and 14 units weekly for women - one unit of alcohol equals about 300 mL of beer or lager, one glass (100 mL) of wine, or 25 mL spirits)

Endpoints (5)

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.

Coverage by outcome category

Glycemic / diabetes
2
Cardiometabolic biomarkers
1
Safety / tolerability / PK
1
Other (unclassified)
1

Glycemic / diabetes

2 endpoints
Primary/protocol endpoint

Area under the serum glucose concentration-time curve

Time frame:At 12 weeks of treatment

descriptive

Secondary/protocol endpoint

Mean postprandial increase in serum glucose concentration

Time frame:At 12 weeks of treatment

Postprandial glucose

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Mean postprandial increase in TG (triglycerides) concentration

Time frame:At 12 weeks of treatment

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Area under the paracetamol plasma concentration-time curve

Time frame:At 12 weeks of treatment

AUC₀–∞

concentration, descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Ad libitum energy intake during a lunch meal (following a standardised breakfast meal)

Time frame:At 12 weeks of treatment

descriptive

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.