The Lira Pump Trial

NCT ID: NCT02351232

Last Updated: 2020-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-10-31

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention

Liraglutide; daily subcutaneous injection; 1.8 mg; 6 months

Group Type: EXPERIMENTAL

Liraglutide

Intervention Type: DRUG

Placebo

Placebo; daily subcutaneous injection; 1.8 mg; 6 months

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Liraglutide

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Victoza

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Steno Diabetes Center Copenhagen

OTHER

Sponsor Role: collaborator

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Signe Schmidt

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kirsten Nørgaard, MD, DMSc

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Locations

Steno Diabetes Center

Gentofte Municipality, , Denmark

Hvidovre University Hospital

Hvidovre, , Denmark

Countries

Denmark

References

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.

Reference Type: RESULT

PMID: 31696598 (View on PubMed)

Other Identifiers

2014-002285-76

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LPT2015

Identifier Type: -

Identifier Source: org_study_id