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Completed

NCT Number: NCT01517555

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

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

Placebo

Drug

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

Paracetamol

Drug

One single dose of 1 g. Tablet

Primary outcomes

  1. Area under the curve of paracetamol

  2. Area under the curve of post prandial plasma glucose

Secondary outcomes

  1. Area under the curve of paracetamol

  2. Cmax, maximum concentration

  3. tmax, time to reach Cmax

  4. t½, terminal half-life

  5. Terminal elimination rate constant

  6. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jan 25, 2012
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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