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

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: liraglutide; Drug: placebo; Drug: paracetamol

• Registration Number: NCT01517555
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Study First Submitted: 2012-01-21
• Study First Submitted QC: 2012-01-21
• Study First Posted: 2012-01-25
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-25
• Last Update Posted: 2017-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Liraglutide	liraglutide	-
Liraglutide	placebo	-
Placebo	placebo	-
Liraglutide	paracetamol	-
Placebo	liraglutide	-
Placebo	paracetamol	-

Primary Outcome Measures

Name	Time	Method
Area under the curve of post prandial plasma glucose
Area under the curve of paracetamol

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Neuss, Germany