DelfaGLP-1 Atlas

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CompletedPhase 1

A Trial Investigating the Effects of Semaglutide on ß-cell Function in Subjects With Type 2 Diabetes

A Single-centre, Randomised, Double-blind, Multiple-dose, Placebo-controlled, Parallel-group Trial Investigating the Effects of Semaglutide on ß-cell Function in Subjects With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

87

actual

Study population

Healthy volunteers, Type 2 diabetes

Key I/E criteria

•BMI 20-35•HbA1c 6.5-9%

Primary endpoints

•AUC of insulin from 0 to 10 minutes after a 25 g glucose bolus i.v. infusion•AUC of insulin from 10-120 minutes after a 25 g glucose bolus i.v. infusion

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 IDNCT02212067
Org study IDNN9535-3635
Secondary ID2013-002173-22
Secondary IDU1111-1143-1206WHO

Timeline

Milestones

Study first posted2014-08-08estimated
Study start2014-08-11actual
Primary completion2015-05-11actual
Study completion2015-05-11actual
Last update posted2018-03-07actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Healthy volunteersType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age64 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Age: 18-64 years (both inclusive) at the time of signing the informed consent
•For subjects with type 2 diabetes:
•Male and female subjects diagnosed with type 2 diabetes
•Treated with diet and exercise and/or metformin monotherapy. Metformin dose should be unchanged in a period of 30 days prior to screening
•Body Mass Index (BMI) between 20.0-35.0 kg/m^2 (both inclusive)
•Glycosylated haemoglobin (HbA1c) between 6.5-9.0 % (both inclusive)
•For healthy control group for graded glucose infusion:
•Healthy male and female subjects
•BMI between 24.0-32.0 kg/m^2 (both inclusive)
•HbA1c less than 6.5 %

Exclusion criteria

•Female who is pregnant, breast-feeding or intends to become pregnant or is of child bearing potential and not using an adequate contraceptive method. Women of child bearing potential must use an effective method of birth control for the duration of the trial and for subjects with type 2 diabetes for 5 weeks following the last dose of semaglutide. Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices), or sexual abstinence or vasectomised partner
•Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiac, pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic
•Use of any prescription or non-prescription medication which could interfere with trial pharmacokinetic or pharmacodynamic results, as judged by the investigator or specifically:
a)current treatment with systemic (oral or i.v.) corticosteroids, non-selective betablockers,
b)thyroid hormones are not allowed unless the use of these have been stable during the past 2 month prior to screening
•History of drug/chemical substance abuse within 1 year prior to screening, or a positive result in the urine drug test
•History of alcohol abuse within 1 year prior to screening, or a positive result in the alcohol breath test
•Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
•Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Endpoints (8)

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.

Glycemic / diabetes

8 endpoints
Primary/protocol endpoint

Area under the serum insulin concentration time curve from 0 to 10 minutes after a 25 g glucose bolus i.v. infusion (IVGTT,intravenous glucose tolerance test) over 2 minutes

Time frame:Day -1, day 86

concentration, descriptive

Primary/protocol endpoint

Area under the serum insulin concentration time curve from 10-120 minutes after a 25 g glucose bolus i.v. infusion (IVGTT).

Time frame:Day -1, day 86

concentration, descriptive

Secondary/protocol endpoint

Area under the insulin secretion rate (ISR)-time curve within 0 to 10 min after i.v. glucose challenge

Time frame:Day -1, day 86

descriptive, improvement

Secondary/protocol endpoint

Area under the ISR-time curve within 10 to 120 min after i.v. glucose challenge

Time frame:Day -1, day 86

concentration, descriptive

Secondary/protocol endpoint/low confidence

24-hour plasma glucose, glucagon, serum insulin, and C-peptide measured as total AUC0-24h during a test day with 3 standardised meals

Time frame:Day -1, day 85

concentration, descriptive

Secondary/protocol endpoint

Area under the insulin secretion rate (ISR)-time curve within 0 to 10 min after i.v. arginine application; ISR will be derived from the C-peptide concentration profile

Time frame:Day -1, day 86

C-peptide AUC

change from baseline, improvement

Secondary/protocol endpoint

Area under the ISR curve over the 5-12 mmol/L (90-216 mg/dL) glucose interval; ISR will be derived from the C-peptide concentration profile

Time frame:Day -1, day 87

C-peptide AUC

descriptive

Secondary/protocol endpoint

Slope of the ISR vs. glucose curve (dose-response relationship)

Time frame:Day -1, day 87

change from baseline, improvement

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.