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LYDIA

CompletedPhase 3

Effects of Liraglutide in Young Adults With Type 2 DIAbetes (LYDIA)

Impact of Liraglutide on Cardiac Function and Structure in Young Adults With Type 2 Diabetes: an Open-label, Randomised Active-comparator Trial

Lead sponsor

University of Leicester

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥30•HbA1c ≥6.5%

Primary endpoint

•Peak early diastolic strain rate

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 IDNCT02043054

Org study ID0398

Secondary ID2012-002422-78

Secondary IDU1111-1131-8802WHO Clinical Trials Registry

Timeline

Milestones

Study start2013-12-16actual

Study first posted2014-01-23estimated

Primary completion2017-09-02actual

Study completion2017-09-29actual

Last update posted2020-01-30actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age60 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Capacity to provide informed consent before any trial-related activities

•Individuals aged 18 - 60 years inclusive

•Established T2DM

•BMI ≥ 30 kg/m2 (≥27 kg/m2 for South Asians or other BME populations)

•On mono or combination oral OAD therapy (sulphonylurea and/or metformin) for ≥ 3months

•No prescribed thiazolidinediones within the last 3 months

•An HbA1c value of greater than or equal to 6.5% and less than 10%

Exclusion criteria

•< 18 years old

•Absolute contraindications to MRI

•Type 1 diabetes (identified through C-peptide analysis)

•Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods

•Suffer from terminal illness

•Have impaired renal function (eGFR < 30 ml/min/1.73m2) )

•Impaired liver function (ALAT≥2.5 times upper limit of normal)

•Known to be Hepatitis B antigen or Hepatitis C antibody positive

•Clinically significant active cardiovascular disease including history of myocardial infarction within the past 6 months and/or heart failure (NYHA class III and IV) at the discretion of the investigator

•Recurrent major hypoglycaemia as judged by the investigator

•Known or suspected allergy to the trial products

•Known or suspected thyroid disease

•Receipt of any investigational drug within four weeks prior to this trial

•Have severe and enduring mental health problems

•Are not primarily responsible for their own care

•Are receiving insulin therapy

•Have taken a thiazolidinedione within the last 3 months

•Any contraindication to Sitagliptin or Liraglutide

•Have severe irritable bowel disorder

•Have pancreatitis or a previous history of pancreatitis

Endpoints (14)

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

Other (unclassified)

Weight & body composition

Cardiometabolic biomarkers

Patient-reported / QoL

Glycemic / diabetes

Heart failure

Safety / tolerability / PK

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Composite Standard Anthropometric variables

Time frame:Changes from baseline to 26 weeks

change from baseline, improvement

componentsBMI, change, Body weight, absolute change (kg), Total fat mass, Waist circumference, change, Systolic BP, change, Diastolic BP, change, Heart rate, change

Secondary/protocol endpoint

MRI defined adiposity

Time frame:Changes from baseline to 26 weeks

change from baseline, improvement

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

Composite 7 point glucose profile

Time frame:Chanegs from baseline to 26 weeks

change from baseline, improvement

Heart failure

1 endpoint

Primary/protocol endpoint

Change in peak early diastolic strain rate measured by cardiac MRI

Time frame:Change from baseline peak end diastolic strain rate at 26 weeks

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Composite chronic low-grade inflammation and adiposity

Time frame:Changes from baseline to 26 weeks

change from baseline, improvement

componentshs-CRP, change, Leptin, change, Adiponectin, change

Secondary/protocol endpoint

Composite Endothelial Function

Time frame:Changes from Baseline to 26 weeks

change from baseline, improvement

Patient-reported / QoL

2 endpoints

Secondary/protocol endpoint/low confidence

Composite Quality of Life and Depression

Time frame:Changes from baseline to 26 weeks

change from baseline, improvement

componentsEQ-5D index, EQ-5D VAS, PGI, change

Secondary/protocol endpoint

Composite treatment and satisfaction

Time frame:Changes from Baseline to 26 weeks

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint/low confidence

Composite Hypoglycemic Episodes

Time frame:Changes from baseline to 26 weeks

descriptive, event

Other (unclassified)

5 endpoints

Secondary/protocol endpoint/low confidence

Composite of standard biochemical variables

Time frame:Changes from baseline to 26 weeks

change from baseline, descriptive

componentsHbA1c, change, ALT, change, AST, change, γ-GT, change, eGFR, change, LDL-C, change, HDL-C, change, Total cholesterol, change, Triglycerides, change

Secondary/protocol endpoint/low confidence

Composite Lifestyle variables

Time frame:Changes from baseline to 26 weeks

change from baseline, improvement

componentscardiorespiratory fitness vo2max, physical activity total and intensity, sedentary time, sitting time

Secondary/protocol endpoint/low confidence

Composite Medication Usage

Time frame:Changes from Baseline to 26 weeks

descriptive

Secondary/protocol endpoint/low confidence

Composite Outcomes

Time frame:Post-26 week analysis

composite event, descriptive

componentsHbA1c <7.0% achievement, Body weight, absolute change (kg), Documented hypoglycemia, Severe hypoglycemia, Systolic BP, change, Treatment-emergent AEs (any)

Secondary/protocol endpoint/low confidence

Composite MRI Outcomes

Time frame:Change from baseline cardiac measures at 26 weeks

change from baseline, improvement

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.

Registry references + supporting bibliography

Rationale and design of the randomised controlled trial to assess the impact of liraglutide on cardiac function and structure in young adults with type 2 diabetes (the LYDIA study).
Cardiovascular diabetology2016 Jul 21PMID27440110doi:10.1186/s12933-016-0421-6via 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.