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Trial · Interventional

CompletedPhase 2/3Registry data

The Lira Pump Trial

NCTNCT02351232 (opens ClinicalTrials.gov in a new tab)Other idLPT2015Other id2014-002285-76Other id2014

Overview

Status
Completed
Phase
Phase 2/3
Enrollment
44 participants (actual)
Sponsor
Hvidovre University Hospital · Other
Design
Randomized · Quadruple masking
Countries
1 country

Denmark

Start
Feb 2015
Primary completion
Oct 2016
Completion
Oct 2016
First posted
30 Jan 2015 (estimated)
Last update posted
12 Feb 2020
Conditions
Type 1 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201520162017
  1. Ph 2/3

    The Lira Pump Trial

    NCT02351232

    Feb 2015 to Oct 2016

Registry summary

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

A randomized placebo-controlled clinical trial investigating the effects of Liraglutide as an add-on to intensive insulin therapy in overweight insulin pump treated type 1 diabetes patients in suboptimal glycemic control.

Interventions

  • LiraglutideDrug
  • PlaceboDrug

Arms2

  • Experimental

    Intervention

    Liraglutide; daily subcutaneous injection; 1.8 mg; 6 months

  • Placebo comparator

    Placebo

    Placebo; daily subcutaneous injection; 1.8 mg; 6 months

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in HbA1c

    Time frame · 6 months

    Registry description

    Change in HbA1c from baseline to end of study (time 6 months)

Secondary outcomes(12)
  1. Change in weight

    Time frame · 6 months

    Registry description

    Change in weight from baseline to end of study (time 6 months)

  2. Change in insulin pump settings

    Time frame · 6 months

    Registry description

    Change in insulin pump settings from baseline to 3 weeks, 3 months and 6 months

  3. Change in glucose variability as measured by continuous glucose monitoring

    Time frame · 6 months

    Registry description

    Change in glucose variability from baseline to 3 weeks, 3 months and 6 months

  4. Change in body composition as measured by DXA-scan

    Time frame · 6 months

    Registry description

    Change in body composition from baseline to 6 months

  5. Change in blood pressure

    Time frame · 6 months

    Registry description

    Change in blood pressure from baseline to 6 months

  6. Change in lipid profile (LDL, HDL, VLDL, total cholesterol, triglycerides)

    Time frame · 6 months

    Registry description

    Change in lipid profile from baseline to 6 months

  7. Frequency of hypoglycemia (patient reported number of episodes with blood glucose <3.9 mmol/l)

    Time frame · 6 months

    Registry description

    Frequency of hypoglycemia during the 6-month study period

  8. Change in kidney function as measured by urine albumine/creatinine ratio

    Time frame · 6 months

    Registry description

    Change in kidney function from baseline to 6 months

  9. Number of daily blood glucose measurements

    Time frame · 6 months

    Registry description

    Number of daily blood glucose measurements during the 6-month study period

  10. Change in diet as measured by retrospective food recording

    Time frame · 6 months

    Registry description

    Change in dietary behavior from baseline to 3 and 6 months

  11. Change in treatment satisfaction as measured by Diabetes Treatment Satisfaction Questionnaire

    Time frame · 6 months

    Registry description

    Change in treatment satisfaction from baseline to 3 and 6 months

  12. Change in anxiety and depression as measured by Hospital Anxiety and Depression Scale

    Time frame · 6 months

    Registry description

    Change in anxiety and depression from baseline to 6 months

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 · 2020

5 results

Liraglutide reduces hyperglycaemia and body weight in overweight, dysregulated insulin-pump-treated patients with type 1 diabetes: The Lira Pump trial-a randomized, double-blinded, placebo-controlled trial.

Dejgaard et al. 2020Diabetes, obesity & metabolismcited by 58

PMID 31696598DOI 10.1111/dom.13911PUB-31696598

Full text at the publisher5 results

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 1 diabetes ≥ 1 year * BMI \> 25 kg/m2 * Insulin pump ≥ 1 year * HbA1c \> 58 mmol/mol * Use of carbohydrate counting and the insulin pump bolus calculator Exclusion Criteria: * Gastroparesis * Impaired renal function (eGFR \< 60 ml/min/1.73m2) * Liver disease with ALAT \> 2.5 times the upper limit of the reference interval * Acute or chronic pancreatitis or history of chronic pancreatitis or idiopathic acute pancreatitis * Inflammatory bowel disease * History of cancer (except basal cell skin cancer) which in the investigators opinion could interfere with the results of the trial, or cancer during the past 5 years * Thyroid adenoma * Subjects with personal or family history of MTC or MEN2 * Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start * Known or suspected alcohol or drug abuse * Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation * Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods. * Simultaneous participation in any other clinical intervention trial * Known or suspected hypersensitivity to Liraglutide * Inability to understand the patient information and to give informed consent * Acute treatment required proliferative retinopathy or maculopathy (macular oedema) * Any Cardiac disorder which in the investigators opinion could interfere with the safety and results of the trial.

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