Skip to content

Trial · Interventional

CompletedPhase 3Registry data

Liraglutide as add-on to Insulin in Type 1 Diabetes

Short name T1DMLIRA

NCTNCT02092896 (opens ClinicalTrials.gov in a new tab)Other id2012-002526-67Other id2012-002526-67
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
40 participants (actual)
Sponsor
Hvidovre University Hospital · Other
Design
Randomized · Quadruple masking
Countries
1 country

Denmark

Start
Mar 2013
Primary completion
Oct 2014
Completion
Oct 2014
First posted
20 Mar 2014 (estimated)
Last update posted
1 Apr 2015 (estimated)
Conditions
Diabetes · Diabetes Mellitus, Type 1

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201320142015
  1. Ph 3

    T1DMLIRA

    NCT02092896

    Mar 2013 to Oct 2014

Registry summary

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

The purpose of this study is to: Part 1: To investigate how 12 weeks treatment with liraglutide affects glycemic control in poorly controlled patients and how the treatment affects gastric emptying rate during hypoglycemia. Part 2: To investigate how 12 weeks treatment of type 1 diabetic patients with liraglutide affects counterregulatory hormones and cognitive performance during hypoglycemia.

Interventions

  • LiraglutideDrug
  • PlaceboDrug
  • LiraglutideDrug
  • PlaceboDrug

Arms4

  • Placebo comparator

    Placebo + Insulin + Study 2

    Study 2: Cognitive performance test

  • Experimental

    Liraglutide + Insulin + Study 2

    Study 2: Cognitive performance test

  • Experimental

    Liraglutide + Insulin + Study 1

    Study 1: Gastric emptying test

  • Placebo comparator

    Placebo + Insulin + Study 1

    Study 1: Gastric emptying test

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Change from baseline in HbA1c (glycosylated haemoglobin)

    Time frame · Week 0, week 12

  2. Changes from baseline in EEG and cognitive performances

    Time frame · week 0, week 12

  3. Change from baseline in gastric emptying rate

    Time frame · week 0, week 12

Secondary outcomes(7)

  1. Change from baseline in glycemic control (CGM)

    Time frame · week 0, week 12

  2. Change from baseline in total daily insulin dose

    Time frame · week 0, week 12

  3. Changes from baseline in the counterregulatory hormone responses during hypoglycemia

    Time frame · week 0, week 12

  4. Change from baseline in body weight

    Time frame · week 0, week 12

  5. Change from baseline in auditory evoked potentials (AEP) during hypoglycemia

    Time frame · week 0, week 12

  6. Change from baseline in corrected QTc-interval (QTc) during hypoglycemia

    Time frame · week 0, week 12

  7. Change from baseline in hypoglycemic symptom score

    Time frame · week 0, week 12

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2015

9 results

Twelve-Week Treatment With Liraglutide as Add-on to Insulin in Normal-Weight Patients With Poorly Controlled Type 1 Diabetes: A Randomized, Placebo-Controlled, Double-Blind Parallel Study.

Frandsen et al. 2015Diabetes carecited by 83

PMID 26486191DOI 10.2337/dc15-1037PUB-26486191

Rights unknown9 results
Source linkSee results (9)

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: * Age: 18-70 years * BMI: 18-28 * HbA1c ≥ 8 % * No residual β-cell function (glucagon test with c-peptide \< 60 pM) * Caucasian * Diagnosed with type 1 diabetes at 5 to 40 years of age (both inclusive). * Remission phase must be completed * Female participants must use adequate contraception * Informed consent Exclusion Criteria: * Overt diabetes complications; creatinin \> 130 µM, proliferative retinopathy, macroalbuminuria. * Autonomic neuropathy (RR-variation \</=10 beats/min) and/or Orthostatic hypotension (OH). * Anemia, Hb concentration; female \<7.0 mmol/l, male\<8.0 mmol/l * Pregnancy or lactation * Epilepsy * Use of antiepileptic medication * Use of beta blockers * Previously apoplexy cerebri. * Any use of benzodiazepine within the last month * Any use of neuroleptic drugs within the last six months * Self-perceived hearing loss * Alcohol or drug abuse * Allergy to the medication or placebo. * Treatment with any medication affecting glucose metabolism. * Any disorder which in the investigators opinion could interfere with the safety and results of the trial

PepBank is a research reference. Talk to a doctor before you use any peptide.