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
Conditions
Interventions
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
Sponsors
Hvidovre University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: -Gastroparesis -Impaired renal function (eGFR 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Primary end point(s): Change in HbA1c;Timepoint(s) of evaluation of this end point: End of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Denmark
Contacts
Public ContactDept. og Endocrinology
Hvidovre Hospital
Outcome results
None listed