The Lira Pump Trial

Hvidovre University Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Type 1 Diabetes

Treatments: Drug: Liraglutide; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02351232

LPT2015

2014-002285-76 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

Liraglutide; daily subcutaneous injection; 1.8 mg; 6 months

Treatment:

Drug: Liraglutide

Placebo

Placebo Comparator group

Description:

Placebo; daily subcutaneous injection; 1.8 mg; 6 months

Treatment:

Drug: Placebo