We updated the design of this site on September 25th. Learn more.

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

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 Intervention Model: Crossover Assignment Masking: Double (Participant, 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:

Drug Information available for: Liraglutide

U.S. FDA Resources

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:

Area under the curve of paracetamol
Area under the curve of post prandial plasma glucose

Secondary Outcome Measures:

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


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01517555

Locations


Germany
Novo Nordisk Investigational Site
Neuss, Germany, 41460

Sponsors and Collaborators

Novo Nordisk A/S

Investigators


Study Director:	Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S

More Information

Additional Information:

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

Publications:

Kapitza C, Zdravkovic M, Hindsberger C, Flint A. The effect of the once-daily human glucagon-like peptide 1 analog liraglutide on the pharmacokinetics of acetaminophen. Adv Ther. 2011 Aug;28(8):650-60. doi: 10.1007/s12325-011-0044-y. Epub 2011 Jul 20.

Flint A, Kapitza C, Hindsberger C, Zdravkovic M. The once-daily human glucagon-like peptide-1 (GLP-1) analog liraglutide improves postprandial glucose levels in type 2 diabetes patients. Adv Ther. 2011 Mar;28(3):213-26. doi: 10.1007/s12325-010-0110-x. Epub 2011 Feb 17.

Flint A, Kapitza C, Zdravkovic M. The once-daily human GLP-1 analogue liraglutide impacts appetite and energy intake in patients with type 2 diabetes after short-term treatment. Diabetes Obes Metab. 2013 Oct;15(10):958-62. doi: 10.1111/dom.12108. Epub 2013 Apr 23.

Røge RM, Klim S, Ingwersen SH, Kjellsson MC, Kristensen NR. The Effects of a GLP-1 Analog on Glucose Homeostasis in Type 2 Diabetes Mellitus Quantified by an Integrated Glucose Insulin Model. CPT Pharmacometrics Syst Pharmacol. 2015 Jan;4(1):e00011. doi: 10.1002/psp4.11. Epub 2014 Dec 30.


Responsible Party:	Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT01517555 History of Changes
Other Study ID Numbers:	NN2211-1698 2006-000561-10 ( EudraCT Number )
First Submitted:	January 21, 2012
First Posted:	January 25, 2012
Last Update Posted:	January 26, 2017
Last Verified:	January 2017

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Liraglutide Acetaminophen Hypoglycemic Agents Physiological Effects of Drugs	Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Antipyretics

To Top