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

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

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
 Drug: liraglutide
Drug: placebo
Drug: paracetamol
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 18
Study Start Date: October 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liraglutide 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
Placebo Comparator: Placebo 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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517555

Locations
Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Milan Zdravkovic, MD, Ph Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01517555     History of Changes
Other Study ID Numbers: NN2211-1698, 2006-000561-10
Study First Received: January 21, 2012
Last Updated: January 21, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Acetaminophen
Glucagon-Like Peptide 1
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 22, 2013