The Lira Pump Trial

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hvidovre University Hospital
• Collaborators: Steno Diabetes Center; Steno Diabetes Center Copenhagen
• Treatments: Liraglutide

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.