DelfaGLP-1 Atlas

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CompletedPhase 1

A Trial Investigating the Effect of Semaglutide on Hypoglycaemic Counterregulation Compared to Placebo in Subjects With Type 2 Diabetes

A Randomised, Single-centre, Double-blind, Cross-over Trial Investigating the Effect of Semaglutide on Hypoglycaemic Counter-regulation Compared to Placebo in Subjects With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

38

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 20-35•HbA1c 6.5-10%

Primary endpoint

•Mean glucagon concentration during hypoglycaemia

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 IDNCT02147431
Org study IDNN9535-3684
Secondary ID2013-002751-15
Secondary IDU1111-1144-7019WHO

Timeline

Milestones

Study start2014-05-21actual
Study first posted2014-05-26estimated
Primary completion2015-05-20actual
Study completion2015-05-20actual
Last update posted2018-08-13actual

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

•Subjects diagnosed with type 2 diabetes and on stable treatment for a period of 90 days prior to screening with metformin as monotherapy. Stable is defined as unchanged dose
•Male or female, age between18-64 years (both inclusive) at the time of signing informed consent
•Body Mass Index (BMI) between 20.0-35.0 kg/m^2 (both inclusive)
•HbA1c (glycosylated haemoglobin) between 6.5-10.0% (both inclusive)

Exclusion criteria

•Treatment with any glucose lowering agent(s) other than metformin in a period of 90 days before screening. An exception is short-term treatment (less than or equal to 7 days in total) with insulin in connection with intercurrent illness
•Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
•Blood or plasma donation within the past month or more than 500 mL within the last 3 months prior to first semaglutide dosing

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
Other (unclassified)
2
Safety / tolerability / PK
1

Glycemic / diabetes

2 endpoints
Primary/protocol endpoint/low confidence

Change in mean glucagon concentration during hypoglycaemia (change from target level 5.5 mmol/L to nadir (target 2.5 mmol/L))

Time frame:After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)

change from baseline, improvement

Secondary/protocol endpoint

Time from termination of insulin infusion at nadir to reach plasma glucose level 4.0 mmol/L

Time frame:After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)

time to event, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint/low confidence

Hypoglycaemic symptoms score

Time frame:After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)

change from baseline, event

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Change in mean glucagon concentration from target level 5.5 mmol/L to 3.5 mmoL/L and from ambient plasma glucose to target levels 5.5 mmol/L, 3.5 mmol/L and nadir

Time frame:After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in mean concentrations of adrenaline, noradrenaline, cortisol and growth hormone from target level 5.5 mmol/L to 3.5 mmol/L and to nadir

Time frame:After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)

change from baseline, descriptive

componentsadrenaline concentration, noradrenaline concentration, cortisol concentration, growth hormone concentration

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.