The Lira Pump Trial

Phase 2

Completed

• Conditions: Type 1 Diabetes
• Interventions: Drug: Liraglutide; Drug: Placebo

• Registration Number: NCT02351232
• Lead Sponsor: Hvidovre University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-27
• Study First Submitted QC: 2015-01-29
• Study First Posted: 2015-01-30
• Study Start: 2015-02
• Status Verified: 2016-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Liraglutide	Liraglutide; daily subcutaneous injection; 1.8 mg; 6 months
Placebo	Placebo	Placebo; daily subcutaneous injection; 1.8 mg; 6 months

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	6 months	Change in HbA1c from baseline to end of study (time 6 months)

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Steno Diabetes Center; 🇩🇰 Gentofte, Denmark

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark