TerminatedPhase 4

GLP-1 and Non-exercise Activity Thermogenesis in RHZ

Liraglutide With or Without NEAT in Type 2 Diabetes Mellitus; Effects on HbA1c, Weight, Blood Pressure, Quality of Life and Health Care Costs.

Lead sponsor

Maastricht University Medical Center

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Obesity / overweight, Type 2 diabetes

Eligibility highlights

•BMI ≥25•HbA1c ≥7%

Primary endpoints

•HbA1c, change•Body weight, absolute change (kg)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01638260

Org study IDMETC 12-2-033

Timeline

Milestones

Study first posted2012-07-11estimated

Last update posted2013-12-17estimated

Study start2012-10 (month precision)

Primary completion2013-11actual (month precision)

Study completion2013-11actual (month precision)

Assets

Investigational agents

Liraglutide

Who this study enrolls

Obesity / overweightType 2 diabetes

Who can enroll

Minimum age40 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Informed consent obtained before any study-related activities

•Men or women with type 2 diabetes mellitus

•Insufficiënt glycaemic control during maximum (tolerable) dose monotherapy with metformin or a sulfonylurea derivate or during combination therapy with metformin and a sulfonylurea derivate or a thiazolinedione

•HbA1c ≥ 7.0% at screening

•BMI ≥ 25.0 kg/m2 at screening

•Age between 40-75 years

Exclusion criteria

•Type 1 diabetes mellitus

•HbA1c ≥ 10% at screening

•Use of GLP-1 receptor agonist (exenatide, liraglutide or other) or pramlintide or any DDP-4 inhibitor within 3 months prior to screening

•Use of insulin within 3 months prior to screening

•An acute coronary or cerebrovascular event in the previous 3 months at screening

•Chronic heart failure NYHA class IV at screening

•Estimated glomerular filtration rate (eGFR) as per Modification of Diet in Renal Disease (MDRD) < 30 ml/min/1.73m2 at screening

•Liver disease, defined as alanine or aspartate aminotransferase levels more than 2.5 the upper limit of normal range at screening

•Malignant neoplasm

•Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or family history of medullary thyroid cancer

•Chronic or acute pancreatitis

•Abuse or dependence of alcohol or drugs (as defined by DSM-IV)

•Any acute condition or exacerbation of chronic condition that would in the investigator's opinion interfere with the study

•Known or suspected hypersensitivity or intolerance to liraglutide

•Known to be uncooperative or noncompliant

•Simultaneous participation in any other clinical study of an investigational product

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

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

Other (unclassified)

Weight & body composition

Glycemic / diabetes

Cardiometabolic biomarkers

Patient-reported / QoL

Weight & body composition

1 endpoint

Primary/protocol endpoint

Change in weight from baseline and end of treatment (26 weeks) and end of follow-up (52 weeks)

Time frame:6 times, screening, week 0, week 13-26-39-52

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

1 endpoint

Primary/protocol endpoint

Change in HbA1c from baseline and end of treatment (26 weeks) and end of follow-up (52 weeks)

Time frame:6 times, screening, week 0, week 13-26-39-52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Change in blood pressure from baseline and end of treatment (26 weeks) and end of follow-up (52 weeks)

Time frame:6 times, screening, week 0, week 13-26-39-52

change from baseline, improvement

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Change in quality of life from baseline and end of treatment (26 weeks) and end of follow-up (52 weeks)

Time frame:3 times, week 0, 26, 52

change from baseline, improvement

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Change in NEAT from baseline and end of treatment (26 weeks) and end of follow-up (52 weeks)

Time frame:3 times, week 0, 26, 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Health-care related costs

Time frame:At baseline, after 26 weeks and after 52 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.