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The Lira Pump Trial

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Liraglutide
Placebo
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Steno Diabetes Center
  • Hvidovre University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Placebo

Arm Description

Liraglutide; daily subcutaneous injection; 1.8 mg; 6 months

Placebo; daily subcutaneous injection; 1.8 mg; 6 months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in weight
Change in weight from baseline to end of study (time 6 months)
Change in insulin pump settings
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
Change in glucose variability from baseline to 3 weeks, 3 months and 6 months
Change in body composition as measured by DXA-scan
Change in body composition from baseline to 6 months
Change in blood pressure
Change in blood pressure from baseline to 6 months
Change in lipid profile (LDL, HDL, VLDL, total cholesterol, triglycerides)
Change in lipid profile from baseline to 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
Change in kidney function as measured by urine albumine/creatinine ratio
Change in kidney function from baseline to 6 months
Number of daily blood glucose measurements
Number of daily blood glucose measurements during the 6-month study period
Change in diet as measured by retrospective food recording
Change in dietary behavior from baseline to 3 and 6 months
Change in treatment satisfaction as measured by Diabetes Treatment Satisfaction Questionnaire
Change in treatment satisfaction from baseline to 3 and 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

Full Information

First Posted
January 27, 2015
Last Updated
February 10, 2020
Sponsor
Hvidovre University Hospital
Collaborators
Steno Diabetes Center Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT02351232
Brief Title
The Lira Pump Trial
Official Title
The Lira Pump Trial. The Effects of Liraglutide in Patients With Insulin Pump Treated Type 1 Diabetes: A Randomized Placebo-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
Collaborators
Steno Diabetes Center Copenhagen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Liraglutide; daily subcutaneous injection; 1.8 mg; 6 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo; daily subcutaneous injection; 1.8 mg; 6 months
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Other Intervention Name(s)
Victoza
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in HbA1c
Description
Change in HbA1c from baseline to end of study (time 6 months)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in weight
Description
Change in weight from baseline to end of study (time 6 months)
Time Frame
6 months
Title
Change in insulin pump settings
Description
Change in insulin pump settings from baseline to 3 weeks, 3 months and 6 months
Time Frame
6 months
Title
Change in glucose variability as measured by continuous glucose monitoring
Description
Change in glucose variability from baseline to 3 weeks, 3 months and 6 months
Time Frame
6 months
Title
Change in body composition as measured by DXA-scan
Description
Change in body composition from baseline to 6 months
Time Frame
6 months
Title
Change in blood pressure
Description
Change in blood pressure from baseline to 6 months
Time Frame
6 months
Title
Change in lipid profile (LDL, HDL, VLDL, total cholesterol, triglycerides)
Description
Change in lipid profile from baseline to 6 months
Time Frame
6 months
Title
Frequency of hypoglycemia (patient reported number of episodes with blood glucose <3.9 mmol/l)
Description
Frequency of hypoglycemia during the 6-month study period
Time Frame
6 months
Title
Change in kidney function as measured by urine albumine/creatinine ratio
Description
Change in kidney function from baseline to 6 months
Time Frame
6 months
Title
Number of daily blood glucose measurements
Description
Number of daily blood glucose measurements during the 6-month study period
Time Frame
6 months
Title
Change in diet as measured by retrospective food recording
Description
Change in dietary behavior from baseline to 3 and 6 months
Time Frame
6 months
Title
Change in treatment satisfaction as measured by Diabetes Treatment Satisfaction Questionnaire
Description
Change in treatment satisfaction from baseline to 3 and 6 months
Time Frame
6 months
Title
Change in anxiety and depression as measured by Hospital Anxiety and Depression Scale
Description
Change in anxiety and depression from baseline to 6 months
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsten Nørgaard, MD, DMSc
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Steno Diabetes Center
City
Gentofte
ZIP/Postal Code
2820
Country
Denmark
Facility Name
Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
31696598
Citation
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.
Results Reference
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The Lira Pump Trial

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