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

INTERVENTION: Trade Name: Victoza Product Name: Liraglutide Pharmaceutical Form: INN or Proposed INN: LIRAGLUTIDE CAS Number: 204656‐20‐2 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6‐ Pharmaceutical form of the placebo: Solution for injection in pre‐filled pen Route of administration of the placebo: Subcutaneous use CONDITION: Therapeutic area: Diseases [C] ‐ Hormonal diseases [C19] Type 1 Diabetes ; MedDRA version: 17.1 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 ‐ Metabolism and nutrition disorders PRIMARY OUTCOME: Main Objective: Change in HbA1c. Primary end point(s): Change in HbA1c Secondary Objective: Change in insulin pump settings, insulin dose, glucose variability, weight/BMI, body composition, blood pressure, lipid profile, frequency of hypoglycemia defined by ADA, kidney function, number of daily blood glucose measurements, diet, treatment satisfaction and symptoms of depression. Timepoint(s) of evaluation of this end point: End of treatment SECONDARY OUTCOME: Secondary end point(s): Change in insulin pump settings, insulin dose, glucose variability, weight/BMI, body composition, blood pressure, lipid profile, frequency of hypoglycemia defined by ADA, kidney function, number of daily blood glucose measurements, diet, treatment satisfaction and symptoms of depression. Timepoint(s) of evaluation of this end point: End of treatment INCLUSION CRITERIA: ‐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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 44 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range