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Trial · Interventional

CompletedPhase 1Registry data

The Effect of Liraglutide Adjunct to Insulin on Glucagon Response to Hypoglycaemia in Subjects With Type 1 Diabetes

NCTNCT01536665 (opens ClinicalTrials.gov in a new tab)Other idNN9211-3953Other idU1111-1123-9882Other id2011-004240-22
Open at ClinicalTrials.govAsk about this trial

Overview

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

Austria

Start
Feb 2012
Primary completion
Aug 2012
Completion
Aug 2012
First posted
22 Feb 2012 (estimated)
Last update posted
8 Feb 2017 (estimated)
Conditions
Diabetes · Diabetes Mellitus, Type 1

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20122013
  1. Ph 1

    The Effect of Liraglutide Adjunct to Insulin on Glucagon Response to Hypoglycaemia in Subjects With Type 1 Diabetes

    NCT01536665

    Feb 2012 to Aug 2012

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 if liraglutide adjunct to insulin treatment changes the glucagon response during hypoglycaemia in subjects with type 1 diabetes compared with conventional insulin treatment after 4 weeks' treatment with liraglutide or placebo. Subjects will initially be randomised to one of the three dose groups, and subsequently randomly allocated to one of two treatment sequences (liraglutide/placebo or placebo/liraglutide).

Interventions

  • liraglutideDrug
  • placeboDrug

Arms3

  • Experimental

    Low

  • Experimental

    Medium

  • Experimental

    High

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Geometric mean glucagon concentration during hypoglycaemia (nadir glucose (target 2.5 mmol/L) )

    Time frame · At week 4

Secondary outcomes(3)

  1. Geometric mean glucagon concentration at plasma glucose levels other than nadir

    Time frame · At week 4

  2. Geometric mean concentrations of adrenaline and noradrenaline at nadir

    Time frame · At week 4

  3. Time from termination of insulin infusion at nadir to reach plasma glucose 4.0

    Time frame · At week 4

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

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2016

4 results

Pharmacokinetic Properties of Liraglutide as Adjunct to Insulin in Subjects with Type 1 Diabetes Mellitus.

Mader et al. 2016Clinical pharmacokineticscited by 10

PMID 27282158PMC5069309DOI 10.1007/s40262-016-0413-4PUB-27282158

Free to read · publisher termsCC BY-NC4 results
Read at sourceSee results (4)

Indexing hint: Randomized controlled trial · 2015

10 results

Counter-regulatory hormone responses to hypoglycaemia in people with type 1 diabetes after 4 weeks of treatment with liraglutide adjunct to insulin: a randomized, placebo-controlled, double-blind, crossover trial.

Pieber et al. 2015Diabetes, obesity & metabolismcited by 39

PMID 25855340DOI 10.1111/dom.12473PUB-25855340

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

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 64 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months prior to randomisation * Body mass index (BMI) between 20.0 and 28.0 kg/m\^2 (both inclusive) Exclusion Criteria: * Use of liraglutide or exenatide within 3 months of randomisation * Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the trial physician or hospitalisation for diabetic ketoacidosis during the previous 6 months * Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening

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