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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT01517555 (opens ClinicalTrials.gov in a new tab)Other idNN2211-1698Other id2006-000561-10
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
18 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
1 country

Germany

Start
Oct 2006
Primary completion
May 2007
Completion
May 2007
First posted
25 Jan 2012 (estimated)
Last update posted
26 Jan 2017 (estimated)
Conditions
Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200620072008
  1. Ph 1

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

    NCT01517555

    Oct 2006 to May 2007

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • liraglutideDrug
  • placeboDrug
  • paracetamolDrug

Arms2

  • Experimental

    Liraglutide

  • Placebo comparator

    Placebo

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Area under the curve of paracetamol

  2. Area under the curve of post prandial plasma glucose

Secondary outcomes(6)

  1. Area under the curve of paracetamol

  2. Cmax, maximum concentration

  3. tmax, time to reach Cmax

  4. t½, terminal half-life

  5. Terminal elimination rate constant

  6. Adverse events

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies4

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Randomized controlled trial · 2013

7 results

The once-daily human GLP-1 analogue liraglutide impacts appetite and energy intake in patients with type 2 diabetes after short-term treatment.

Flint et al. 2013Diabetes, obesity & metabolismcited by 36

PMID 23551925DOI 10.1111/dom.12108PUB-23551925

Full text at the publisher7 results
Publisher pageSee results (7)

Indexing hint: Randomized controlled trial · 2011

7 results

The once-daily human glucagon-like peptide-1 (GLP-1) analog liraglutide improves postprandial glucose levels in type 2 diabetes patients.

Flint et al. 2011Advances in therapycited by 70

PMID 21340616DOI 10.1007/s12325-010-0110-xPUB-21340616

Full text at the publisher7 results
Publisher pageSee results (7)

Indexing hint: Randomized controlled trial · 2011

4 results

The effect of the once-daily human glucagon-like peptide 1 analog liraglutide on the pharmacokinetics of acetaminophen.

Kapitza et al. 2011Advances in therapycited by 27

PMID 21792552DOI 10.1007/s12325-011-0044-yPUB-21792552

Full text at the publisher4 results
Publisher pageSee results (4)

More studies

1 study on this page

PubMed tag: none · 2015

The Effects of a GLP-1 Analog on Glucose Homeostasis in Type 2 Diabetes Mellitus Quantified by an Integrated Glucose Insulin Model.

Røge et al. 2015CPT: pharmacometrics & systems pharmacologycited by 8

PMID 26225223PMC4369758DOI 10.1002/psp4.11PUB-26225223

Free to read · publisher termsCC BY-NC
Read at source

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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