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

The Lira Pump Trial

Sponsors

Lead sponsor: Hvidovre University Hospital

Collaborator: Steno Diabetes Center Copenhagen

Source 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.

Overall Status Completed
Start Date February 2015
Completion Date October 2016
Primary Completion Date October 2016
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in HbA1c 6 months
Secondary Outcome
Measure Time Frame
Change in weight 6 months
Change in insulin pump settings 6 months
Change in glucose variability as measured by continuous glucose monitoring 6 months
Change in body composition as measured by DXA-scan 6 months
Change in blood pressure 6 months
Change in lipid profile (LDL, HDL, VLDL, total cholesterol, triglycerides) 6 months
Frequency of hypoglycemia (patient reported number of episodes with blood glucose <3.9 mmol/l) 6 months
Change in kidney function as measured by urine albumine/creatinine ratio 6 months
Number of daily blood glucose measurements 6 months
Change in diet as measured by retrospective food recording 6 months
Change in treatment satisfaction as measured by Diabetes Treatment Satisfaction Questionnaire 6 months
Change in anxiety and depression as measured by Hospital Anxiety and Depression Scale 6 months
Enrollment 44
Condition
Intervention

Intervention type: Drug

Intervention name: Liraglutide

Arm group label: Intervention

Other name: Victoza

Intervention type: Drug

Intervention name: Placebo

Arm group label: Placebo

Eligibility

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.

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Kirsten Nørgaard, MD, DMSc Principal Investigator Hvidovre University Hospital
Location
facility
Steno Diabetes Center | Gentofte, 2820, Denmark
Hvidovre University Hospital | Hvidovre, 2650, Denmark
Location Countries

Denmark

Verification Date

October 2016

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Hvidovre University Hospital

Investigator full name: Signe Schmidt

Investigator title: MD, PhD

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Intervention

Arm group type: Experimental

Description: Liraglutide; daily subcutaneous injection; 1.8 mg; 6 months

Arm group label: Placebo

Arm group type: Placebo Comparator

Description: Placebo; daily subcutaneous injection; 1.8 mg; 6 months

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov