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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: placebo

Drug: liraglutide

Drug: paracetamol

Study type

Interventional

Funder types

Industry

Identifiers

NCT01517555

2006-000561-10 (EudraCT Number)

NN2211-1698

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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