The Lira Pump Trial

Type 1 Diabetes Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02351232
• Other study ID #: LPT2015
• Secondary ID: 2014-002285-76
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 2015
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• Liraglutide

• Placebo

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center	Gentofte
Denmark	Hvidovre University Hospital	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Steno Diabetes Center Copenhagen

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Dejgaard TF, Schmidt S, Frandsen CS, Vistisen D, Madsbad S, Andersen HU, Nørgaard K. Liraglutide reduces hyperglycaemia and body weight in overweight, dysregulated insulin-pump-treated patients with type 1 diabetes: The Lira Pump trial-a randomized, doubl — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	Change in HbA1c from baseline to end of study (time 6 months)	6 months
Secondary	Change in weight	Change in weight from baseline to end of study (time 6 months)	6 months
Secondary	Change in insulin pump settings	Change in insulin pump settings from baseline to 3 weeks, 3 months and 6 months	6 months
Secondary	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
Secondary	Change in body composition as measured by DXA-scan	Change in body composition from baseline to 6 months	6 months
Secondary	Change in blood pressure	Change in blood pressure from baseline to 6 months	6 months
Secondary	Change in lipid profile (LDL, HDL, VLDL, total cholesterol, triglycerides)	Change in lipid profile from baseline to 6 months	6 months
Secondary	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
Secondary	Change in kidney function as measured by urine albumine/creatinine ratio	Change in kidney function from baseline to 6 months	6 months
Secondary	Number of daily blood glucose measurements	Number of daily blood glucose measurements during the 6-month study period	6 months
Secondary	Change in diet as measured by retrospective food recording	Change in dietary behavior from baseline to 3 and 6 months	6 months
Secondary	Change in treatment satisfaction as measured by Diabetes Treatment Satisfaction Questionnaire	Change in treatment satisfaction from baseline to 3 and 6 months	6 months
Secondary	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