Clinical trial NCT02351232: The Lira Pump Trial
Official title: The Lira Pump Trial. The Effects of Liraglutide in Patients With Insulin Pump Treated Type 1 Diabetes: A Randomized Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Type 1 Diabetes
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Steno Diabetes Center Copenhagen
First posted: 2015-01-30
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in HbA1c
timeFrame: 6 months
Secondary outcomes:
measure: Change in weight
timeFrame: 6 months
measure: Change in insulin pump settings
timeFrame: 6 months
measure: Change in glucose variability as measured by continuous glucose monitoring
timeFrame: 6 months
measure: Change in body composition as measured by DXA-scan
timeFrame: 6 months
measure: Change in blood pressure
timeFrame: 6 months
measure: Change in lipid profile (LDL, HDL, VLDL, total cholesterol, triglycerides)
timeFrame: 6 months
measure: Frequency of hypoglycemia (patient reported number of episodes with blood glucose <3.9 mmol/l)
timeFrame: 6 months
measure: Change in kidney function as measured by urine albumine/creatinine ratio
timeFrame: 6 months
measure: Number of daily blood glucose measurements
timeFrame: 6 months
measure: Change in diet as measured by retrospective food recording
timeFrame: 6 months
measure: Change in treatment satisfaction as measured by Diabetes Treatment Satisfaction Questionnaire
timeFrame: 6 months
measure: Change in anxiety and depression as measured by Hospital Anxiety and Depression Scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Steno Diabetes Center
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: Hvidovre University Hospital
name: Kirsten Nørgaard, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.