Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

All Conditions

Diabetes Mellitus

Diabetes Mellitus, Type 2

Metabolic Diseases

Glucose Metabolism Disorders

Endocrine System Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Liraglutide

No treatment is actively administered. Patients are treated according to routine clinical practice at the discretion of their treating physicians.

No treatment given

Global Clinical Registry (GCR, 1452)

This study is conducted in the United States of America. The aim of this study is to estimate incidence rates of all malignant neoplasms, specific subgroups of malignant neoplasms, and acute pancreatitis among cohorts of antidiabetic drug users standardized to be representative of LEADER™ trial participants or liraglutide initiators within the Humedica Electronic Health Record (EHR) database.

Estimation of Malignancy Rates Within Humedica Patient Populations Sampled to be Representative of Liraglutide Initiators and LEADER™ Trial Participants

Novo Nordisk A/S

Neoplasms

Symptoms and General Pathology

Rare Diseases

Carcinoma

Thyroid Neoplasms

Thyroid Diseases

Body Weight

Carcinoma, Neuroendocrine

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Adenocarcinoma

Neoplasms, Nerve Tissue

Thyroid Cancer, Medullary

Neuroendocrine Tumor

Neuroepithelioma

Gastrointestinal Agents

Anti-Obesity Agents

Glucagon

Semaglutide

Glucagon-Like Peptide 1

Dulaglutide

Exenatide

Annette Stemhagen, DrPH, FISPE

This study is conducted in the United States of America (USA). The aim of the study is to monitor the number of annual new adult cases of medullary thyroid carcinoma (MTC) and to establish a registry for these new cases in order to identify any possible increase related to the introduction of liraglutide, exenatide once-weekly, and other GLP-1 receptor agonists into the US market.

This active surveillance program will monitor for any signal indicating a possible association between treatment with long-acting GLP-1 RAs and the development of MTC in the United States population. Given the very low incidence of MTC in the general population, the expected rate of exposure to long-acting GLP-1 RAs, the anticipated long latency of the potential outcome under study and the limited data on underlying risk factors for development of MTC other than RET proto-oncogene mutations, an active surveillance program is the most efficient means of identifying a possible association between MTC and products in the long-acting GLP-1 RAs class. Given the uncertainty of the association of MTC in humans treated with these drugs, a study duration of at least fifteen years from the time of market introduction of the first long-acting GLP-1 RA was thought to provide evidence of an association, if one exists. If such an association is identified, a case-control study will be initiated to quantify the association.

The MTC registry is a Food and Drug Administration (FDA) post-marketing requirement for long-acting GLP-1 RA products. Because of the rarity of MTC and in order to minimize inconvenience to patients, physicians, and state cancer registries, FDA encouraged sponsors of long-acting GLP-1 RAs to work collaboratively to conduct this registry. Consequently, the MTC Registry Consortium has been formed for this purpose.

The MTC Registry Consortium refers to the Sponsors with approved long-acting GLP-1 RAs who have a contractual agreement to participate in the MTC Registry.

This active surveillance program for cases of MTC will be conducted with assistance from the North American Association of Central Cancer Registries (NAACCR). NAACCR is a collaborative umbrella organization for cancer registries, government agencies, professional organizations, and private groups in North America interested in improving the quality and use of cancer registry data. All of the central cancer registries in the U.S. and Canada are members of NAACCR, including those that participate in SEER.

An Active Surveillance Program for Cases of Medullary Thyroid Carcinoma (MTC)

Medullary Thyroid Carcinoma Surveillance Study: A Case-Series Registry

Currently this is undecided for this 15 year registry. The Data Monitoring Committee is a group of external interdisciplinary consultants who oversee the registry data to review if there are any signals or safety concerns with patients who have taken any of the long-acting GLP-1 RAs and were diagnosed with medullary thyroid carcinoma.

AstraZeneca

Eli Lilly and Company

United BioSource, LLC

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Estimation of Malignancy Rates Within Humedica Patient Populations Sampled to be Representative of Liraglutide Initiators and LEADER™ Trial Participants	NCT02608853	Diabetes Diabetes Mellit...	No treatment gi...	-	Novo Nordisk A/S
An Active Surveillance Program for Cases of Medullary Thyroid Carcinoma (MTC)	NCT01511393	Diabetes Diabetes Mellit... Medullary Thyro... Weight Manageme...	No treatment gi...	18 Years -	Novo Nordisk A/S

Spots Global Cancer Trial Database for no treatment given