The Lira Pump Trial
The Effects of Liraglutide in Patients With Insulin Pump Treated Type 1 Diabetes, A Randomized, Placebo-Controlled Trial.
The aim of this study is to investigate the effects of Liraglutide as an add-on to intensive insulin therapy in adult CSII-treated T1D patients who are in suboptimal glycemic control and overweight.
Design and method
We hypothesize that the addition of GLP-1 to intensive CSII treatment will improve glycemic control significantly. We test the hypothesis in a 26-week, two-armed, parallel, randomized, double-blinded, placebo-controlled dual-center study. Patients will be randomly assigned in a 1:1 ratio to either the treatment arm in which they receive GLP-1 or to the control arm in which they receive placebo. After 26 weeks, the treatment allocation is revealed and the patients return to routine clinical control with quarterly consultations.
- Age 18 – 70 years
- T1D ≥ 1 years
- BMI > 25 kg/m2
- HbA1c ≥ 58 mmol/mol (7.5%)
- CSII use ≥ 1 year
- Use of carbohydrate counting and the insulin pump bolus calculator
- 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.
The study targets overweight CSII-treated T1D patients who are not in good glycemic control.
Expected ending and outcome
The primary outcome parameter is change in HbA1c. Secondary outcome parameters include change in insulin pump settings, insulin dose, glucose variability, weight/BMI, body composition, blood pressure, lipid profile, frequency of hypoglycemia, number of daily blood glucose measurements, diet, treatment satisfaction and symptoms of depression.
Dept. of Endocrinology, Hvidovre University Hospital
and Steno Diabetes Center
Sidst opdateret 11-07-2016