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Clinical Trial Details

Trial ID: L1115
Source ID: NCT03921242
Associated Drug: Metformin
Title: Comparative Effectiveness of Metformin for Type 2 Diabetes With Chronic Kidney Disease
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2|Renal Insufficiency, Chronic
Interventions: DRUG: Metformin|DRUG: Sulfonylurea|DRUG: DPP-4 inhibitor|DRUG: SGLT2 inhibitor|DRUG: GLP1 receptor agonist
Outcome Measures: Primary: Incidence of Severe Hypoglycemia Assessed from EMR, Comparing the time-to event outcomes between metformin and other index exposures. Severe Hypoglycemic events are defined as events resulting in emergency room, observation, or inpatient visits where hypoglycemia is the primary diagnosis, 18 Months|Difference in Glycosylated Hemoglobin (HbA1c) level (mmol/mol), Comparing the change in HbA1c in the metformin-initiator cohort to the changes reported in the sulfonylurea- and DPP4-I-initiator cohorts at 3-9 months following baseline. HbA1c will be measured in mmol/mol., 24 Months|Heterogeneity of Treatment Effect Via Pre-specified Sub-Group Analyses, Determine the extent of heterogeneity in treatment effect through the stratification of the sample population by covariate subgroups (age, sex, BMI, race; baseline history of CVD, liver disease, and heart failure; specific sulfonylurea or DPP-4 inhibitor, and levels of renal function and metformin dose as time-varying covariates) and through the use of machine learning techniques., 25 Months | Secondary: Incidence of acidosis, hospitalization for hyperglycemia, acute myocardial infarction, stroke, heart failure hospitalization, and heart failure emergency room visits, Comparing the time-to event outcomes between the metformin and other index exposure cohorts in terms of occurrences of acidosis, hospitalizations for hyperglycemia, acute myocardial infarction, stroke, heart failure hospitalizations, and heart failure emergency room visits, 18 Months|Difference in Glycosylated Hemoglobin (HbA1c) level (mmol/mol), Comparing the change in HbA1c in the metformin-initiator cohort to the changes reported in the sulfonylurea- and DPP4-I-initiator cohorts at 12-24 months following baseline. HbA1c will be measured in mmol/mol., 24 Months|Difference in Body-Mass Index Assessed From EMR (BMI) (kg/m2), Comparing the change in body-mass index (BMI) in the metformin-initiator cohort to the changes reported in the sulfonylurea- and DPP4-I-initiator cohorts. BMI will be measured in kg/m2., 24 Months|Difference in Laboratory-Measured eGFR (mL/min), Comparing the change in eGFR in the metformin-initiator cohort to the changes reported in the sulfonylurea- and DPP4-I-initiator cohorts. eGFR will be measured in mL/min., 24 Months
Sponsor/Collaborators: Sponsor: Weill Medical College of Cornell University | Collaborators: Patient-Centered Outcomes Research Institute
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 4888
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2019-08-01
Completion Date: 2023-08-01
Results First Posted:
Last Update Posted: 2023-11-09
Locations: University of North Carolina, Chapel Hill, North Carolina, 27599, United States|Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States
URL: https://clinicaltrials.gov/show/NCT03921242