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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01517555
First Posted: January 25, 2012
Last Update Posted: January 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
January 21, 2012
January 25, 2012
January 26, 2017
October 2006
May 2007   (Final data collection date for primary outcome measure)
  • Area under the curve of paracetamol
  • Area under the curve of post prandial plasma glucose
Same as current
Complete list of historical versions of study NCT01517555 on ClinicalTrials.gov Archive Site
  • Area under the curve of paracetamol
  • Cmax, maximum concentration
  • tmax, time to reach Cmax
  • t½, terminal half-life
  • Terminal elimination rate constant
  • Adverse events
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: liraglutide
    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
  • Drug: placebo
    Administered as a subcutaneous injection. Given as daily volume of 100 mcl, 200 mcl and 300 mcl respectively
  • Drug: paracetamol
    One single dose of 1 g. Tablet
  • Experimental: Liraglutide
    Interventions:
    • Drug: liraglutide
    • Drug: placebo
    • Drug: paracetamol
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: liraglutide
    • Drug: placebo
    • Drug: paracetamol

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
May 2007
May 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01517555
NN2211-1698
2006-000561-10 ( EudraCT Number )
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP