GLP-1 Peptide Atlas, by Delfa

CompletedPhase 4

Liraglutide in Type 1 Diabetes

Liraglutide in Type 1 Diabetes. A Randomised, Double-blind, Placebo Controlled Study of the Effect of Liraglutide as an Additional Treatment to Insulin on HbA1c, Body Weight and Hypoglycaemia in Poorly Regulated Type 1 Diabetes Patients

Lead sponsor

Steno Diabetes Center Copenhagen

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

100

actual

Study population

Obesity / overweight, Type 1 diabetes

Key I/E criteria

•BMI ≥25•HbA1c ≥8%

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 IDNCT01612468

Org study IDLira1

Timeline

Milestones

Study first posted2012-06-05estimated

Last update posted2016-01-27estimated

Study start2012-06 (month precision)

Primary completion2015-02actual (month precision)

Study completion2015-02actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Obesity / overweightType 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Type 1 diabetes according to WHO criteria ≥ 1 year

•Age ≥ 18 years

•BMI > 25 kg/m2

•HbA1c > 8.0 % at visit 0

Exclusion criteria

•Insulin pump treatment

•Hypoglycaemia unawareness (unability to register low blood glucose)

•Diabetic gastroparesis

•Compromised kidney function (eGFR < 60 ml/min/1,73m2), dialysis or kidney transplantation at visit 0

•Liver disease with elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)

•Acute or chronic pancreatitis

•Inflammatory bowel disease

•Cancer unless in complete remission for > 5 years

•History of thyroid adenoma or carcinoma

•Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation

•Alcohol/drug abuse

•Fertile women not using contraceptives

•Pregnant or nursing women

•Known or suspected hypersensitivity to trial product or related products

•Receipt of an investigational drug within 30 days prior to visit 0

•Simultaneous participation in any other clinical intervention trial

Endpoints (6)

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

Weight & body composition

Cardiometabolic biomarkers

Patient-reported / QoL

Other (unclassified)

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Body weight

Time frame:24 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Primary/protocol endpoint

Change in HbA1c

Time frame:24 week

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Glycaemic excursions

Time frame:24 weeks

descriptive, improvement

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Cardiovascular

Time frame:24 weeks

change from baseline, improvement

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint/low confidence

Quality of life

Time frame:24 weeks

change from baseline, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Standardised liquid meal test

Time frame:24 weeks

descriptive

Publications (2)

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.

Registry references + supporting bibliography

Efficacy and safety of liraglutide for overweight adult patients with type 1 diabetes and insufficient glycaemic control (Lira-1): a randomised, double-blind, placebo-controlled trial.
The lancet. Diabetes & endocrinology2016 Mar (month)PMID26656289doi:10.1016/S2213-8587(15)00436-2via clinicaltrials gov reference derived + pubmed nct search
Efficacy and safety of the glucagon-like peptide-1 receptor agonist liraglutide added to insulin therapy in poorly regulated patients with type 1 diabetes--a protocol for a randomised, double-blind, placebo-controlled study: the Lira-1 study.
BMJ open2015 Apr 2PMID25838513doi:10.1136/bmjopen-2015-007791via clinicaltrials gov reference derived + pubmed nct search

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.