Effect of Liraglutide on Absorption of Paracetamol in Subjects With Type 2 Diabetes - Full Text View

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: 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: Acetaminophen 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


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

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Please refer to this study by its ClinicalTrials.gov identifier: 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 )
Study First Received:	January 21, 2012
Last Updated:	January 25, 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

ClinicalTrials.gov processed this record on May 25, 2017