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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01517555
First received: January 21, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted

January 21, 2012
January 21, 2012
October 2006
May 2007   (final data collection date for primary outcome measure)
  • Area under the curve of paracetamol [ Designated as safety issue: No ]
  • Area under the curve of post prandial plasma glucose [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Area under the curve of paracetamol [ Designated as safety issue: No ]
  • Cmax, maximum concentration [ Designated as safety issue: No ]
  • tmax, time to reach Cmax [ Designated as safety issue: No ]
  • t½, terminal half-life [ Designated as safety issue: No ]
  • Terminal elimination rate constant [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]
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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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
Not Provided

*   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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01517555
NN2211-1698, 2006-000561-10
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Milan Zdravkovic, MD, Ph Novo Nordisk A/S
Novo Nordisk A/S
January 2012

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