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

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Acetaminophen; Liraglutide

Criteria

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