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Type 1 DiabetesPhase 2/3NCT02351232

The Lira Pump Trial

A Phase 2/3 study testing Liraglutide in people with Type 1 Diabetes, run by Hvidovre University Hospital at 2 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Liraglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
2 sitesDenmark
Study dates
Feb 2015to Oct 2016
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

  • Steno Diabetes Center

    Gentofte Municipality, 2820

  • Hvidovre University Hospital

    Hvidovre, 2650

Other trials in Denmark

About this study

Official title: The Lira Pump Trial. The Effects of Liraglutide in Patients With Insulin Pump Treated Type 1 Diabetes: A Randomized Placebo-Controlled Trial

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.

Conditions
Type 1 Diabetes
Being tested
Liraglutide, Placebo
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LiraglutideDrug

    Also called Victoza

  • PlaceboDrug

Study groups in NCT02351232
Study groupRoleWhat they receive
InterventionExperimentalLiraglutide; daily subcutaneous injection; 1.8 mg; 6 months
Receives: Drug: Liraglutide
PlaceboPlacebo comparatorPlacebo; daily subcutaneous injection; 1.8 mg; 6 months
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c

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

    Measured: 6 months

Secondary outcomes (12)

  1. Change in weight

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

    Measured: 6 months

  2. Change in insulin pump settings

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

    Measured: 6 months

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

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

    Measured: 6 months

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

    Change in body composition from baseline to 6 months

    Measured: 6 months

  5. Change in blood pressure

    Change in blood pressure from baseline to 6 months

    Measured: 6 months

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

    Change in lipid profile from baseline to 6 months

    Measured: 6 months

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

    Frequency of hypoglycemia during the 6-month study period

    Measured: 6 months

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

    Change in kidney function from baseline to 6 months

    Measured: 6 months

  9. Number of daily blood glucose measurements

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

    Measured: 6 months

  10. Change in diet as measured by retrospective food recording

    Change in dietary behavior from baseline to 3 and 6 months

    Measured: 6 months

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

    Change in treatment satisfaction from baseline to 3 and 6 months

    Measured: 6 months

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

    Change in anxiety and depression from baseline to 6 months

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionOct 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02351232
Sponsor's protocol ID
LPT2015
Other IDs
2014-002285-76, 2014
Status last verified
Oct 2016
First submitted
27 Jan 2015
Last updated
12 Feb 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Dejgaard TF, Schmidt S, Frandsen CS, Vistisen D, Madsbad S, Andersen HU, Norgaard K. 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. Diabetes Obes Metab. 2020 Apr;22(4):492-500. doi: 10.1111/dom.13911. Epub 2019 Dec 19.

    PubMed 31696598

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Liraglutide in people with Type 1 Diabetes, run by Hvidovre University Hospital at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02351232, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.

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