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Clinical Trial Details

Trial ID: L4086
Source ID: NCT03627039
Associated Drug: Sglt2
Title: Metformin And Cardiovascular Effectiveness vs SGLT2 (MACES)
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: SGLT2|DRUG: Metformin
Outcome Measures: Primary: Cardiovascular composite (stroke, myocardial infarction, heart failure), The outcome will be identified using ICD9 and ICD10 codes and reported as rates of acute myocardial infarction, heart failure, stroke (they will only be analyzed individually if there are sufficient number of one of the events defined as \> 30 events), Follow-up will begin one day after cohort entry and continue until medication discontinuation, study outcome, or no further data. Most patients will have 200 days of follow up | Secondary: Harms: Hypoglycemia, Hypoglycemia: identified using ICD9 and ICD10 codes and reported as rates, Follow-up will begin one day after cohort entry and continue until medication discontinuation, study outcome, or no further data. Most patients will have 200 days of follow up|Harms: diabetic ketoacidosis, Diabetic ketoacidosis: identified using ICD9 and ICD10 codes and reported as rates, Follow-up will begin one day after cohort entry and continue until medication discontinuation, study outcome, or no further data. Most patients will have 200 days of follow up|Harms: lactic acidosis, Lactic acidosis: identified using ICD9 and ICD10 codes and reported as rates, Follow-up will begin one day after cohort entry and continue until medication discontinuation, study outcome, or no further data. Most patients will have 200 days of follow up|Harms: Acute kidney injury, Acute kidney injury: identified using ICD9 and ICD10 codes and reported as rates, Follow-up will begin one day after cohort entry and continue until medication discontinuation, study outcome, or no further data. Most patients will have 200 days of follow up|Harms: Genital infection, Genital infection: identified using ICD9 and ICD10 codes and reported as rates, Follow-up will begin one day after cohort entry and continue until medication discontinuation, study outcome, or no further data. Most patients will have 200 days of follow up|Costs, Costs of metformin compared to SGLT2. Estimates for costs associated with the individual outcomes., Follow-up will begin one day after cohort entry and cost analysis will end 1 year thereafter | Other: Tracer outcomes, The outcome will be identified using ICD9 and ICD10 codes and reported as rates (1) Cellulitis, Follow-up will begin one day after cohort entry and continue until medication discontinuation, study outcome, or no further data. Most patients will have 200 days of follow up
Sponsor/Collaborators: Sponsor: Brigham and Women's Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 20000
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2018-09-01
Completion Date: 2020-08-01
Results First Posted:
Last Update Posted: 2019-08-13
Locations: Division of Pharmacoepidemiology and Pharmacoeconomics, Boston, Massachusetts, 02130, United States
URL: https://clinicaltrials.gov/show/NCT03627039