Metformin vs SGLT2-Inhibitor: Cardiovascular Effects in Diabetes Patients
This observational study aims to compare the effects of Metformin and SGLT2-Inhibitor on cardiovascular health in diabetes patients, focusing on events such as stroke, myocardial infarction, and heart failure.
Data Collection
Collected from past medical records and data - RetrospectiveDiabetes Mellitus+3
+ Diabetes Mellitus, Type 2
+ Endocrine System Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: September 1, 2018
Actual date on which the first participant was enrolled.The MACES study focuses on comparing the effectiveness of two diabetes medications, Metformin and SGLT2-inhibitors, in relation to cardiovascular health. This research targets individuals with diabetes and pre-existing heart conditions, aiming to understand which drug better reduces the risk of heart-related complications. The study takes into account various factors like existing medical conditions, diabetes severity, healthcare usage, prescriber characteristics, and other medications. The potential findings of this study could help improve treatment strategies for diabetic patients with heart disease, ensuring they receive the most effective care. In this observational study, participants are matched based on their likelihood of receiving either Metformin or an SGLT2-inhibitor, taking into account numerous baseline factors. This matching process helps to balance the comparison between the two treatment groups. The study's primary outcome measures the incidence of cardiovascular events, such as stroke, myocardial infarction, and heart failure, using ICD9 and ICD10 codes. These events will only be analyzed individually if there are more than 30 instances of a specific event. The study also conducts sensitivity analyses and may assess the primary risk in patients with a history of cardiovascular disease, if a sufficient sample size is available. To ensure the accuracy of the results, researchers will also conduct a tracer analysis using cellulitis as an outcome, as it is unrelated to both SGLT2s and Metformin.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20000 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
INCLUSION: \- all patients newly prescribed an SGLT2 or metformin between March 29, 2013 to January 1st, 2017 with at least 6 months of continuous enrollment (1 year in a sensitivity analysis) EXCLUSION: * age \< 18 years * previous use of any diabetes medication * lack of a diagnosis of type 2 diabetes mellitus * history of malignant neoplasm * dialysis * type 1 diabetes
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Division of Pharmacoepidemiology and Pharmacoeconomics
Boston, United StatesOpen Division of Pharmacoepidemiology and Pharmacoeconomics in Google Maps