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CompletedPhase 1

The Effect of Liraglutide Adjunct to Insulin on Glucagon Response to Hypoglycaemia in Subjects With Type 1 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

45

actual

Study population

Type 1 diabetes

Key I/E criterion

BMI 20-28

Primary endpoint

Geometric 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 IDNCT01536665
Org study IDNN9211-3953
Secondary ID2011-004240-22
Secondary IDU1111-1123-9882WHO

Timeline

Milestones

Study first posted2012-02-22estimated
Last update posted2017-02-08estimated
Study start2012-02 (month precision)
Primary completion2012-08actual (month precision)
Study completion2012-08actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age64 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months prior to randomisation
Body mass index (BMI) between 20.0 and 28.0 kg/m^2 (both inclusive)

Exclusion criteria

Use of liraglutide or exenatide within 3 months of randomisation
Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the trial physician or hospitalisation for diabetic ketoacidosis during the previous 6 months
Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening

Endpoints (4)

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

Other (unclassified)
3
Glycemic / diabetes
1

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint/low confidence

Time from termination of insulin infusion at nadir to reach plasma glucose 4.0

Time frame:At week 4

time to event, improvement

Other (unclassified)

3 endpoints
Primary/protocol endpoint/low confidence

Geometric mean glucagon concentration during hypoglycaemia (nadir glucose (target 2.5 mmol/L) )

Time frame:At week 4

concentration, descriptive

Secondary/protocol endpoint/low confidence

Geometric mean glucagon concentration at plasma glucose levels other than nadir

Time frame:At week 4

concentration, descriptive

Secondary/protocol endpoint/low confidence

Geometric mean concentrations of adrenaline and noradrenaline at nadir

Time frame:At week 4

concentration, descriptive

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.

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.