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Trial · Interventional

CompletedPhase 1Registry data

A Trial to Assess the Effect of Liraglutide on Blood Triglyceride (Fat) Levels After a Meal in Type 2 Diabetics

NCTNCT00993304 (opens ClinicalTrials.gov in a new tab)Other idNN2211-3534Other id2008-003229-18Other idU1111-1111-9161Other id2008
Open at ClinicalTrials.govAsk about this trial

Overview

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

Denmark

Start
Oct 2009
Primary completion
Dec 2010
Completion
Dec 2010
First posted
12 Oct 2009 (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
200920102011
  1. Ph 1

    A Trial to Assess the Effect of Liraglutide on Blood Triglyceride (Fat) Levels After a Meal in Type 2 Diabetics

    NCT00993304

    Oct 2009 to Dec 2010

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 investigate whether a new compound, liraglutide, reduces the level of lipids (fat), including cholesterol, in the blood of type 2 diabetics, following a meal with high fat content.

Interventions

  • liraglutideDrug
  • placeboDrug

Arms2

  • Experimental

    A

  • Placebo comparator

    B

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. AUC0-8h (triglyceride), the area under the triglyceride-concentration-time curve in the interval 0-8 hours following a meal with a high fat content

    Time frame · after 3 weeks of treatment

Secondary outcomes(2)

  1. FFA (Free Fatty Acid), VLDL (Very Low Density), and apoB48: AUC0-8 hours after meal with a high fat content

    Time frame · after 3 weeks of treatment

  2. Glucose, insulin, C-peptide and glucagon: AUC0-8 hours after meal with a high fat content

    Time frame · after 3 weeks of treatment

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

Studies3

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2015

3 results

Comparable liraglutide pharmacokinetics in pediatric and adult populations with type 2 diabetes: a population pharmacokinetic analysis.

Petri et al. 2015Clinical pharmacokineticscited by 26

PMID 25603819PMC4449373DOI 10.1007/s40262-014-0229-zPUB-25603819

Free to read · publisher termsCC BY-NC3 results
Read at sourceSee results (3)

Indexing hint: Randomized controlled trial · 2013

10 results

Liraglutide suppresses postprandial triglyceride and apolipoprotein B48 elevations after a fat-rich meal in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, cross-over trial.

Hermansen et al. 2013Diabetes, obesity & metabolismcited by 121

PMID 23683069DOI 10.1111/dom.12133PUB-23683069

Full text at the publisher10 results
Publisher pageSee results (10)

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
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Subjects with type 2 diabetes mellitus (diet and exercise treated, or treated with specific oral antidiabetics (metformin, sulfonylureas and glinides) mono- or combination therapy) diagnosed at least 3 months previously * BMI between 18.5 and 40 kg/m2 * HbA1c between 6.5 and 10.0% both inclusive Exclusion Criteria: * Known or suspected allergy to trial products or related products * Previous participation in this trial (randomised). Re-screening of screening failures is allowed only once * Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptives are defined as combination oral contraceptives (OC), hormonal intra uterine devices (IUDs), implants and injectables; for Germany, a condom for the male partner must be used in combination with OC, IUD, implant or injectables for the duration of the trial and for 30 days following the last dose of trial medication) if not sterile or post-menopausal * The receipt of any investigational drug within 3 months prior to this trial * Previous insulin treatment (short-term insulin treatment of up to 7 days are exempted if this has occurred no later than 3 months prior to screening). * Cancer (except basal cell skin cancer or squamous cell skin cancer) or any clinically significant disorder (except type 2 diabetes) * Clinically significant active cardiovascular disease including history of myocardial infarction (heart attack) within the past 6 months and/or heart failure at the discretion of the Investigator. * History of alcoholism or drug abuse during the last 12 months * Blood donation within the last 3 months. Plasma donation within the last month. * Additional exclusion criteria for Germany: Male subjects who are sexually active and have partners who are or could be pregnant, not using a barrier method of contraception (e.g. condom) for the duration of the trial and for 30 days following the last dose of trial medication

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