DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT01686945

CompletedPhase 1

Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects and Male Subjects With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

107

actual

Study population

Healthy volunteers, Type 2 diabetes

Key I/E criteria

•BMI ≤30•HbA1c 6.5-9%•Male•Healthy volunteers

Primary endpoint

•Treatment-emergent AEs (any)

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 IDNCT01686945
Org study IDNN9924-3991
Secondary ID2012-000361-20
Secondary IDU1111-1127-4408WHO

Timeline

Milestones

Study first posted2012-09-18estimated
Study start2012-09-19actual
Primary completion2013-04-08actual
Study completion2013-04-08actual
Last update posted2019-01-04actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Healthy volunteersType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age64 Years
SexMale
Healthy volunteersAccepted

Inclusion criteria

•Male subject, who is considered to be generally healthy, based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and laboratory safety tests performed during the screening visit, as judged by the investigator. This also applies to subjects with T2D, except for the underlying diabetes with or without associated hyperlipidaemia and/or hypertension
•Body mass index (BMI):
a)Healthy subjects: above or equal to 20 and below 30 kg/m^2.
b)Subjects with T2D: BMI above or equal to 20 and below or equal to 37 kg/m^2
•Glycosylated haemoglobin (HbA1c):
a)Healthy subjects: below 6.0%.
b)Subjects with T2D: between 6.5 and 9.0% (both inclusive)
•Additional inclusion criterion only for subjects with T2D: Male subjects with T2D (diagnosed within the past 10 years) treated with diet and exercise and/or who have been on stable doses of metformin for at least 12 weeks prior to Visit 3 (Day -1 or 0) and for whom no changes in treatment are planned for the trial period

Exclusion criteria

•History of, or presence of, cancer, diabetes (only for healthy subjects) or any clinically significant cardiovascular (only for healthy subjects), respiratory, metabolic, renal, hepatic, gastro-intestinal (GI), endocrinological (except diabetes in subjects with T2D), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator
•Blood pressure in supine position at the screening examination above:
a)140 mmHg systolic and/or above 90 mmHg diastolic for healthy subjects.
b)160 mmHg systolic and/or above 95 mmHg diastolic for subjects with T2D
•Use of prescription or non-prescription medicinal products (except routine vitamins) within three weeks preceding the dosing. Occasional use of paracetamol or acetylsalicylic acid is permitted. a. For subjects with T2D: Any other current diabetes treatment apart from metformin (e.g. treatment with incretin mimetics, Dipeptidyl Peptidase-IV (DPP-IV) inhibitors, insulin secretagogues, insulin or thiazolidinediones (TZDs)). Use of blood lipidregulating agents, as well as blood pressure regulating, and thrombo-embolic agents is allowed
•Exclusion criteria only for subjects with T2D:
•Proliferative retinopathy or maculopathy requiring acute treatment as determined by funduscopy/fundus photography and judged by the investigator. If subject presents a medical certificate for funduscopy/fundus photography performed within last 3 months this can substitute the funduscopy/fundus photography at screening
•Nephropathy stages 3 to 5, i.e. estimated glomerular filtration rate (eGFR) below 60. The eGFRshould be determined using the Modification of Diet in Renal Disease 4-variable method encompassing creatinine, age, gender, and race
•Diabetic peripheral neuropathy using the 10 g Semmes-Weinstein monofilament examination at the great toe or plantar aspect of the fifth metatarsal
•Clinically significant active cardiovascular disease including history of myocardial infarction and/or heart failure (New York Heart Association (NYHA) class III and IV1) at the discretion of the investigator

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.

Coverage by outcome category

Glycemic / diabetes
4
Safety / tolerability / PK
2
Other (unclassified)
1

Glycemic / diabetes

4 endpoints
Secondary/protocol endpoint

Change from baseline in fasting plasma glucose (FPG)

Time frame:Week 0, week 10 (Day 69)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change from baseline in C-peptide

Time frame:Week 0, week 10 (Day 69)

C-peptide AUC

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in insulin

Time frame:Week 0, week 10 (Day 69)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in glycosylated haemoglobin type A1c (HbA1c)

Time frame:Week 0, week 10 (Day 69)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

Number of treatment emergent adverse events (TEAEs) recorded

Time frame:From the time of first dosing and until completion of the post treatment follow-up visits (Day 90 to 104)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Area under the plasma concentration curve over the dosing interval (0-24 hours)

Time frame:After the last 3 daily doses for semaglutide and carrier

AUC₀–∞

concentration, descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Change from baseline in glucagon

Time frame:Week 0, week 10 (Day 69)

change from baseline, improvement

Publications (2)

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.