The Lira Pump Trial

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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Drug: Placebo; Drug: Liraglutide

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Gentofte, Denmark, 2820
    • Steno Diabetes center
  • Hvidovre, Denmark, 2650
    • Hvidovre University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Liraglutide; daily subcutaneous injection; 1.8 mg; 6 months	Drug: Liraglutide; Other Names: Victoza
Placebo Comparator: Placebo; Placebo; daily subcutaneous injection; 1.8 mg; 6 months	Drug: Placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Collaborators: Steno Diabetes Center Copenhagen
• Investigators: Principal Investigator: Kirsten Nørgaard, MD, DMSc, Hvidovre University Hospital

Publications and helpful links

General Publications

• Dejgaard TF, Schmidt S, Frandsen CS, Vistisen D, Madsbad S, Andersen HU, Norgaard K. Liraglutide reduces hyperglycaemia and body weight in overweight, dysregulated insulin-pump-treated patients with type 1 diabetes: The Lira Pump trial-a randomized, double-blinded, placebo-controlled trial. Diabetes Obes Metab. 2020 Apr;22(4):492-500. doi: 10.1111/dom.13911. Epub 2019 Dec 19.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: January 27, 2015
• First Submitted That Met QC Criteria: January 29, 2015
• First Posted (Estimate): January 30, 2015

Study Record Updates

• Last Update Posted (Actual): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide
• Other Study ID Numbers: LPT2015; 2014-002285-76 (EudraCT Number)