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

Phase 1

• Conditions: Type 1 Diabetes; MedDRA version: 17.1Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2014-002285-76-DK
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-08
• Last Update Posted: 9 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 44

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

-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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