Massive data study checks if diabetes drug protects hearts
NCT ID NCT06659744
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed study analyzed health records from over 158,000 people with type 2 diabetes to see if injectable semaglutide reduces major heart problems like heart attacks and strokes. Researchers used real-world data to mimic a previous clinical trial, aiming to learn when such data can be trusted. The study did not involve new treatments or direct patient contact.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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158,310 people
The number who actually took part.
- Started
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Oct 2024
- Finished
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Mar 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population included patients with Type 2 Diabetes (Type2DM) who had not been treated with antihyperglycemic agents or had been treated with no more than two oral antihyperglycemic agents, with or without NPH or long-acting insulin, \>=50 years with established cardiovascular disease OR \>=60 years with subclinical cardiovascular disease.
- Ages
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50 years and older
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Eligible cohort entry dates: Market availability of injectable semaglutide in the US began on 5th December 2017. Optum: Study period between 5th Dec 2017 - 29th February 2024 Marketscan: Study period between 5th Dec 2017 - 31st Dec 2022 Medicare: Study period between 5th Dec 2017 - 31st Dec 2020 Inclusion Criteria: * Type 2 diabetes mellitus * Anti-diabetic drug naïve, or treated with one or two oral antidiabetic drug (OADs), or treated with human Neutral Protamin Hagedorn (NPH) insulin or long-acting insulin analogue or pre-mixed insulin, both types of insulin either alone or in combination with one or two OADs * Age above or equal to 50 years at screening and clinical evidence of cardiovascular disease: prior myocardial infarction, prior stroke or prior transient ischemic attack, prior coronary, carotid or peripheral arterial revascularization, more than 50% stenosis on angiography or imaging of coronary, carotid or lower extremities arteries, chronic heart failure - New York Heart Association (NYHA) class II-III, chronic renal impairment documents by estimated eGFR \<60ml/min/1.73 m2 per MDRD * Age 60 years or older with subclinical evidence of cardiovascular disease. Subclinical cardiovascular risk factors as one of the following: persistent microalbuminuria (30-299mg/g) or proteinuria, ankle/brachial index less than 0.9 Exclusion Criteria: * Type 1 diabetes mellitus, secondary or gestational diabetes * Use of glucagon-like peptide-1 (GLP-1) receptor agonist (exenatide, liraglutide, or other) or pramlintide within 90 days prior to screening * Use of any dipeptidyl peptidase 4 (DPP-IV) inhibitor within 30 days prior to screening * Treatment with insulin other than basal and pre-mixed insulin within 90 days prior to screening - except for short-term use in connection with intercurrent illness * Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (eg diabetes ketoacidosis) within 90 days prior to screening * History of chronic pancreatitis or idiopathic acute pancreatitis * Acute coronary or cerebro-vascular event within 90 days prior to randomization * Chronic heart failure New York Heart Association (NYHA) class IV * Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma * Personal history of non-familial medullary thyroid carcinoma * Chronic hemodialysis or peritoneal dialysis * End stage liver disease * A prior solid organ transplant or awaiting solid organ transplant * Diagnosis of malignant neoplasm in the previous 5 years * Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using an adequate contraceptive method * Known use of non-prescribed narcotics or illicit drugs * Proliferative retinopathy or maculopathy requiring treatment * Missing age or gender * Nursing home admission
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, 02120, United States
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Other studies related to the condition(s) this trial covers.
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