CompletedPhase 1

Effect of Liraglutide on Absorption of Paracetamol in Subjects With Type 2 Diabetes

A Single Centre, Randomised, Double-blind, Placebo Controlled Trial to Evaluate the Possible Drug-drug Interaction Between Liraglutide and Paracetamol and the Effects of Liraglutide on Postprandial Glucose and Insulin, Gastric Emptying, Appetite Sensations and Energy Intake in Subjects With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 2 diabetes

Eligibility highlights

•BMI 18.5-40•HbA1c 7.5-9.5%

Primary endpoints

•Area under the curve of paracetamol•Postprandial glucose

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01517555

Org study IDNN2211-1698

Secondary ID2006-000561-10

Timeline

Milestones

Study first posted2012-01-25estimated

Last update posted2017-01-26estimated

Study start2006-10 (month precision)

Primary completion2007-05actual (month precision)

Study completion2007-05actual (month precision)

Assets

Investigational agents

Liraglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Type 2 diabetes mellitus

•Diet-treated subjects with type 2 diabetes with HbA1c 7.5-9.5 %

•Subjects with type 2 diabetes in oral anti-diabetic drug (OAD) monotherapy treated with metformin or alpha-glucosidase inhibitors with HbA1c 7.0-9.5%

•Body mass index (BMI) 18.5-40 kg/m^2

•Subjects should have a stable body weight for at least 3 months prior to screening (as judged by the Investigator)

Exclusion criteria

•Impaired liver function

•Impaired renal function

•Clinically significant active cardiovascular disease including history of myocardial infarction within the last 6 months and/or heart failure

•Any clinically significant abnormal ECG (electrocardiogram)

•Uncontrolled treated/untreated hypertension

•Recurrent severe hypoglycaemia as judged by the Investigator

•Active hepatitis B and/or active hepatitis C

•Positive human immunodeficiency virus (HIV) antibodies

•Known or suspected allergy to trial product(s) or related products

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.

Coverage by outcome category

Safety / tolerability / PK

Glycemic / diabetes

1 endpoint

Primary/protocol endpoint

Area under the curve of post prandial plasma glucose

Postprandial glucose

descriptive, improvement

Safety / tolerability / PK

7 endpoints

Primary/protocol endpoint

Area under the curve of paracetamol

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

Area under the curve of paracetamol

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

Cmax, maximum concentration

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax, time to reach Cmax

Tmax

descriptive

Secondary/protocol endpoint

t½, terminal half-life

Half-life

descriptive

Secondary/protocol endpoint

Terminal elimination rate constant

descriptive

Secondary/protocol endpoint

Adverse events

Treatment-emergent AEs (any)

descriptive

Publications (4)

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

The Effects of a GLP-1 Analog on Glucose Homeostasis in Type 2 Diabetes Mellitus Quantified by an Integrated Glucose Insulin Model.
CPT: pharmacometrics & systems pharmacology2015 Jan (month)PMID26225223doi:10.1002/psp4.11via CT.gov reference
The once-daily human GLP-1 analogue liraglutide impacts appetite and energy intake in patients with type 2 diabetes after short-term treatment.
Diabetes, obesity & metabolism2013 Oct (month)PMID23551925doi:10.1111/dom.12108via CT.gov reference
The effect of the once-daily human glucagon-like peptide 1 analog liraglutide on the pharmacokinetics of acetaminophen.
Advances in therapy2011 Aug (month)PMID21792552doi:10.1007/s12325-011-0044-yvia CT.gov reference
The once-daily human glucagon-like peptide-1 (GLP-1) analog liraglutide improves postprandial glucose levels in type 2 diabetes patients.
Advances in therapy2011 Mar (month)PMID21340616doi:10.1007/s12325-010-0110-xvia CT.gov reference

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.