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CompletedPhase 2, PHASE3

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

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

2

Recruiting sites

Enrollment

44

actual

Study population

Obesity / overweight, Type 1 diabetes

Key I/E criterion

BMI ≥25

Primary endpoint

HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02351232
Org study IDLPT2015
Secondary ID2014-002285-76

Timeline

Milestones

Study first posted2015-01-30estimated
Last update posted2020-02-12actual
Study start2015-02 (month precision)
Primary completion2016-10actual (month precision)
Study completion2016-10actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (13)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
3
Weight & body composition
2
Cardiometabolic biomarkers
2
Patient-reported / QoL
2
Other (unclassified)
2
Renal / kidney
1
Safety / tolerability / PK
1

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Change in weight

Time frame:6 months

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in body composition as measured by DXA-scan

Time frame:6 months

change from baseline, improvement

Glycemic / diabetes

3 endpoints
Primary/protocol endpoint

Change in HbA1c

Time frame:6 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

Change in glucose variability as measured by continuous glucose monitoring

Time frame:6 months

change from baseline, improvement

Secondary/protocol endpoint

Number of daily blood glucose measurements

Time frame:6 months

descriptive

Renal / kidney

1 endpoint
Secondary/protocol endpoint

Change in kidney function as measured by urine albumine/creatinine ratio

Time frame:6 months

uACR, change

change from baseline, improvement

LOINC 9318-7

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Change in blood pressure

Time frame:6 months

change from baseline, improvement

Secondary/protocol endpoint

Change in lipid profile (LDL, HDL, VLDL, total cholesterol, triglycerides)

Time frame:6 months

change from baseline, improvement

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint

Change in treatment satisfaction as measured by Diabetes Treatment Satisfaction Questionnaire

Time frame:6 months

change from baseline, improvement

Secondary/protocol endpoint

Change in anxiety and depression as measured by Hospital Anxiety and Depression Scale

Time frame:6 months

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Frequency of hypoglycemia (patient reported number of episodes with blood glucose <3.9 mmol/l)

Time frame:6 months

Documented hypoglycemia

event count, event

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Change in insulin pump settings

Time frame:6 months

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in diet as measured by retrospective food recording

Time frame:6 months

change from baseline, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.