The Lira Pump Trial

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Drug: Liraglutide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Liraglutide; daily subcutaneous injection; 1.8 mg; 6 months | Drug: Liraglutide<br> <br> * Other names: Victoza;|
| Placebo Comparator: Placebo<br>Placebo; daily subcutaneous injection; 1.8 mg; 6 months | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c | Change in HbA1c from baseline to end of study (time 6 months) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight | Change in weight from baseline to end of study (time 6 months) | 6 months | 
| Change in insulin pump settings | Change in insulin pump settings from baseline to 3 weeks, 3 months and 6 months | 6 months | 
| Change in glucose variability as measured by continuous glucose monitoring | Change in glucose variability from baseline to 3 weeks, 3 months and 6 months | 6 months | 
| Change in body composition as measured by DXA-scan | Change in body composition from baseline to 6 months | 6 months | 
| Change in blood pressure | Change in blood pressure from baseline to 6 months | 6 months | 
| Change in lipid profile (LDL, HDL, VLDL, total cholesterol, triglycerides) | Change in lipid profile from baseline to 6 months | 6 months | 
| Frequency of hypoglycemia (patient reported number of episodes with blood glucose <3.9 mmol/l) | Frequency of hypoglycemia during the 6-month study period | 6 months | 
| Change in kidney function as measured by urine albumine/creatinine ratio | Change in kidney function from baseline to 6 months | 6 months | 
| Number of daily blood glucose measurements | Number of daily blood glucose measurements during the 6-month study period | 6 months | 
| Change in diet as measured by retrospective food recording | Change in dietary behavior from baseline to 3 and 6 months | 6 months | 
| Change in treatment satisfaction as measured by Diabetes Treatment Satisfaction Questionnaire | Change in treatment satisfaction from baseline to 3 and 6 months | 6 months | 
| Change in anxiety and depression as measured by Hospital Anxiety and Depression Scale | Change in anxiety and depression from baseline to 6 months | 6 months |