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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01517555

Enrollment

Registered

2012-01-25

Start date

2006-10-31

Completion date

2007-05-31

Last updated

2017-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

Brief summary

This trial is conducted in Europe. The aim of this trial is to to investigate if there is a drug-drug interaction between liraglutide and paracetamol (Benuron®) and to investigate the effect of liraglutide on post prandial glucose.

Interventions

DRUGparacetamol

One single dose of 1 g. Tablet

DRUGliraglutide

Administered as a subcutaneous injection. Initial dose 0.6 mg daily, adjusted to 1.2 mg daily in week 2 and escalated to 1.8 mg daily in week 3

DRUGplacebo

Administered as a subcutaneous injection. Given as daily volume of 100 mcl, 200 mcl and 300 mcl respectively

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Area under the curve of paracetamol	—
Area under the curve of post prandial plasma glucose	—

Secondary

Measure	Time frame
tmax, time to reach Cmax	—
t½, terminal half-life	—
Area under the curve of paracetamol	—
Adverse events	—
Terminal elimination rate constant	—
Cmax, maximum concentration	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026