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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
liraglutide
placebo
paracetamol
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Liraglutide

Placebo

Arm Description

Outcomes

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

Full Information

First Posted
January 21, 2012
Last Updated
January 25, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01517555
Brief Title
Effect of Liraglutide on Absorption of Paracetamol in Subjects With Type 2 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liraglutide
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Administered as a subcutaneous injection. Given as daily volume of 100 mcl, 200 mcl and 300 mcl respectively
Intervention Type
Drug
Intervention Name(s)
paracetamol
Intervention Description
One single dose of 1 g. Tablet
Primary Outcome Measure Information:
Title
Area under the curve of paracetamol
Title
Area under the curve of post prandial plasma glucose
Secondary Outcome Measure Information:
Title
Area under the curve of paracetamol
Title
Cmax, maximum concentration
Title
tmax, time to reach Cmax
Title
t½, terminal half-life
Title
Terminal elimination rate constant
Title
Adverse events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Neuss
ZIP/Postal Code
41460
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
21792552
Citation
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.
Results Reference
result
PubMed Identifier
21340616
Citation
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.
Results Reference
result
PubMed Identifier
23551925
Citation
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.
Results Reference
result
PubMed Identifier
26225223
Citation
Roge 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.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

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

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