Skip to content

Trial · Interventional

CompletedPhase 4Registry data

Liraglutide in Type 1 Diabetes

NCTNCT01612468 (opens ClinicalTrials.gov in a new tab)Other idLira1
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
100 participants (actual)
Sponsor
Steno Diabetes Center Copenhagen · Other
Design
Randomized · Triple masking
Countries
1 country

Denmark

Start
Jun 2012
Primary completion
Feb 2015
Completion
Feb 2015
First posted
5 Jun 2012 (estimated)
Last update posted
27 Jan 2016 (estimated)
Conditions
Diabetes Mellitus, Type 1 · Overweight

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20122013201420152016
  1. Ph 4

    Liraglutide in Type 1 Diabetes

    NCT01612468

    Jun 2012 to Feb 2015

Registry summary

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

A randomised, double-blind, placebo controlled study of the effect of liraglutide as an additional treatment to insulin on HbA1c, body weight and hypoglycaemia in poorly regulated type 1 diabetes patients. Background: Treatment with glucagon-like peptid 1 (GLP-1) agonists liraglutide and exanatide leads to weight loss and decrease in haemoglobin A1c in oral anti diabetic treated type 2 diabetes patients. It is estimated that 40-50 % of type 1 diabetes patients in the US suffers from overweight or poor glycaemic control (HbA1c \> 8 %). Small studies, not placebo controlled, reports effects of adding liraglutide to a group of well regulated (HbA1c \< 7.5 %) normal to overweight insulin treated type 1 diabetes patients for 24 weeks. A decrease in HbA1c, weight, insulin doses and glycaemic excursions measured by continuous glucose monitoring was seen. Primary objective:To investigate the effect of liraglutide 1.8 mg once daily compared to placebo for 24 weeks on change in HbA1c in patients with type 1 diabetes as an add-on therapy to insulin. Secondary objectives:To investigate the effect of liraglutide as an add-on therapy to insulin compared to placebo on change in:Weight, insulin dose,hypoglycaemic events, CGM, BMI, body composition, quality of life, treatment satisfaction,food preferences, meal test, CIMT, PWV and 24 hour blood pressure.

Interventions

  • LiraglutideDrug
  • PlaceboDrug

Arms2

  • Experimental

    Liraglutide

  • Placebo comparator

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in HbA1c

    Time frame · 24 week

    Registry description

    To investigate the effect of liraglutide 1.8 mg once daily compared to placebo for 24 weeks on change in HbA1c in patients with type 1 diabetes as an adjunctive therapy to insulin treatment.

Secondary outcomes(5)

  1. Body weight

    Time frame · 24 weeks

    Registry description

    To investigate the effect of liraglutide 1.8 mg once daily compared to placebo for 24 weeks on change in weight, BMI and body composition

  2. Cardiovascular

    Time frame · 24 weeks

    Registry description

    To investigate the effect of liraglutide 1.8 mg once daily compared to placebo for 24 weeks on change in carotis intima media thickness, pulse wave velocity, 24 hour blood pressure

  3. Standardised liquid meal test

    Time frame · 24 weeks

    Registry description

    To investigate the effect of liraglutide 1.8 mg once daily compared to placebo for 24 weeks on change in postprandial glucagon levels, glycaemic excursion, gastric emptying, VAS score for appetite and food preference

  4. Glycaemic excursions

    Time frame · 24 weeks

    Registry description

    To investigate the effect of liraglutide 1.8 mg once daily compared to placebo for 24 weeks on change in insulin dose, hypoglycaemic events and glycaemic excursions (time spent in hypo- and hyperglycaemia as measured by CGM)

  5. Quality of life

    Time frame · 24 weeks

    Registry description

    To investigate the effect of liraglutide 1.8 mg once daily compared to placebo for 24 weeks on change in quality of life and treatment satisfaction

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

1 study on this page

Indexing hint: Randomized controlled trial · 2016

18 results

Efficacy and safety of liraglutide for overweight adult patients with type 1 diabetes and insufficient glycaemic control (Lira-1): a randomised, double-blind, placebo-controlled trial.

Dejgaard et al. 2016The lancet. Diabetes & endocrinologycited by 142

PMID 26656289DOI 10.1016/s2213-8587(15)00436-2PUB-26656289

Full text at the publisher18 results
Publisher pageSee results (18)

Indexing hint: Randomized controlled trial · 2015

Efficacy and safety of the glucagon-like peptide-1 receptor agonist liraglutide added to insulin therapy in poorly regulated patients with type 1 diabetes--a protocol for a randomised, double-blind, placebo-controlled study: the Lira-1 study.

Dejgaard et al. 2015BMJ opencited by 12

PMID 25838513PMC4390685DOI 10.1136/bmjopen-2015-007791PUB-25838513

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: * Type 1 diabetes according to WHO criteria ≥ 1 year * Age ≥ 18 years * BMI \> 25 kg/m2 * HbA1c \> 8.0 % at visit 0 Exclusion Criteria: * Insulin pump treatment * Hypoglycaemia unawareness (unability to register low blood glucose) * Diabetic gastroparesis * Compromised kidney function (eGFR \< 60 ml/min/1,73m2), dialysis or kidney transplantation at visit 0 * Liver disease with elevated plasma alanine aminotransferase (ALT) \> three times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive) * Acute or chronic pancreatitis * Inflammatory bowel disease * Cancer unless in complete remission for \> 5 years * History of thyroid adenoma or carcinoma * Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation * Alcohol/drug abuse * Fertile women not using contraceptives * Pregnant or nursing women * Known or suspected hypersensitivity to trial product or related products * Receipt of an investigational drug within 30 days prior to visit 0 * Simultaneous participation in any other clinical intervention trial

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