Trial Outcomes & Findings for Second-line Therapies for Patients With Type 2 Diabetes and Moderate Cardiovascular Disease Risk (NCT NCT05214573)

NCT ID: NCT05214573

Last Updated: 2025-10-10

Results Overview

The probability of 3-point MACEs experienced by subjects treated with DPP4i, GLP-1RA, SGLT2i, or Sulfonylureas (SU) defined as non-fatal myocardial infarction (MI), non-fatal stroke, and mortality. The probability was calculated and reported as the hazard ratio.

Recruitment status

COMPLETED

Target enrollment

386301 participants

Primary outcome timeframe

Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period

Results posted on

2025-10-10

Participant Flow

Participants in the arm "Aims 1, 2B, and 3 groups", were considered enrolled in the trial even though this arm was exempt from Mayo Clinic Institutional Review Board review and informed consent requirements were not applicable as this arm used deidentified administrative claims data.

Participant milestones

Participant milestones
Measure
Aims 1, 2B, and 3 Groups
De-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D) were utilized to identify adults (≥21 years) with T2D (established using validated Healthcare Effectiveness Data and Information Set criteria) who first filled any study drug GLP-1RA, SGLT2i, DPP-4i, or SU between 1/1/2014-12/31/2021. The arm was exempt from Mayo Clinic Institutional Review Board review and informed consent requirements were not applicable as this arm used deidentified administrative claims data. Glucagon like peptide 1 receptor agonist: Patients in the data who filled a glucagon-like peptide-1 receptor agonist medication Sodium-glucose cotransporter 2 inhibitor: Patients in the data who filled a sodium-glucose cotransporter 2 inhibitor Dipeptidyl Peptidase 4 Inhibitor: Patients in the data who filled a dipeptidyl peptidase-4 inhibitor Sulfonylurea: Patients in the data who filled a sulfonylurea
Aim 2A Group
Adults with Type 2 diabetes treated with one or more of the study medications (GLP-1RA, SGLT2i, DPP-4i, or SU) and not treated with insulin who received medical care at Mayo Clinic Rochester or Mayo Clinic Health System in Minnesota or Wisconsin. This arm was not exempt from Mayo Clinic Institutional Review Board review and informed consent requirements were applicable as this arm collected prospective data.
Overall Study
STARTED
386276
25
Overall Study
COMPLETED
380352
25
Overall Study
NOT COMPLETED
5924
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Aims 1, 2B, and 3 Groups
De-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D) were utilized to identify adults (≥21 years) with T2D (established using validated Healthcare Effectiveness Data and Information Set criteria) who first filled any study drug GLP-1RA, SGLT2i, DPP-4i, or SU between 1/1/2014-12/31/2021. The arm was exempt from Mayo Clinic Institutional Review Board review and informed consent requirements were not applicable as this arm used deidentified administrative claims data. Glucagon like peptide 1 receptor agonist: Patients in the data who filled a glucagon-like peptide-1 receptor agonist medication Sodium-glucose cotransporter 2 inhibitor: Patients in the data who filled a sodium-glucose cotransporter 2 inhibitor Dipeptidyl Peptidase 4 Inhibitor: Patients in the data who filled a dipeptidyl peptidase-4 inhibitor Sulfonylurea: Patients in the data who filled a sulfonylurea
Aim 2A Group
Adults with Type 2 diabetes treated with one or more of the study medications (GLP-1RA, SGLT2i, DPP-4i, or SU) and not treated with insulin who received medical care at Mayo Clinic Rochester or Mayo Clinic Health System in Minnesota or Wisconsin. This arm was not exempt from Mayo Clinic Institutional Review Board review and informed consent requirements were applicable as this arm collected prospective data.
Overall Study
Physician Decision
5924
0

Baseline Characteristics

Second-line Therapies for Patients With Type 2 Diabetes and Moderate Cardiovascular Disease Risk

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Aims 1, 2B, and 3 Groups
n=386276 Participants
De-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D) were utilized to identify adults (≥21 years) with T2D (established using validated Healthcare Effectiveness Data and Information Set criteria) who first filled any study drug GLP-1RA, SGLT2i, DPP-4i, or SU between 1/1/2014-12/31/2021. The arm was exempt from Mayo Clinic Institutional Review Board review and informed consent requirements were not applicable as this arm used deidentified administrative claims data. Glucagon like peptide 1 receptor agonist: Patients in the data who filled a glucagon-like peptide-1 receptor agonist medication Sodium-glucose cotransporter 2 inhibitor: Patients in the data who filled a sodium-glucose cotransporter 2 inhibitor Dipeptidyl Peptidase 4 Inhibitor: Patients in the data who filled a dipeptidyl peptidase-4 inhibitor Sulfonylurea: Patients in the data who filled a sulfonylurea
Aim 2A Group
n=25 Participants
Adults with Type 2 diabetes treated with one or more of the study medications (GLP-1RA, SGLT2i, DPP-4i, or SU) and not treated with insulin who received medical care at Mayo Clinic Rochester or Mayo Clinic Health System in Minnesota or Wisconsin. This arm was not exempt from Mayo Clinic Institutional Review Board review and informed consent requirements were applicable as this arm collected prospective data.
Total
n=386301 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
131786 Participants
n=5 Participants
19 Participants
n=7 Participants
131805 Participants
n=5 Participants
Age, Categorical
>=65 years
254490 Participants
n=5 Participants
6 Participants
n=7 Participants
254496 Participants
n=5 Participants
Sex: Female, Male
Female
190394 Participants
n=5 Participants
13 Participants
n=7 Participants
190407 Participants
n=5 Participants
Sex: Female, Male
Male
195882 Participants
n=5 Participants
12 Participants
n=7 Participants
195894 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
33165 Participants
n=5 Participants
5 Participants
n=7 Participants
33170 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
341028 Participants
n=5 Participants
19 Participants
n=7 Participants
341047 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
12083 Participants
n=5 Participants
1 Participants
n=7 Participants
12084 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
10982 Participants
n=5 Participants
0 Participants
n=7 Participants
10982 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
39454 Participants
n=5 Participants
1 Participants
n=7 Participants
39455 Participants
n=5 Participants
Race (NIH/OMB)
White
285574 Participants
n=5 Participants
20 Participants
n=7 Participants
285594 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
50266 Participants
n=5 Participants
4 Participants
n=7 Participants
50270 Participants
n=5 Participants
Region of Enrollment
United States
386276 participants
n=5 Participants
25 participants
n=7 Participants
386301 participants
n=5 Participants

PRIMARY outcome

Timeframe: Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period

Population: 380352 total participants were analyzed. Those 380352 participants were further broken down into the following categories DPP4i (82438), GLP-1RA (44255), SGLT2i (46473), Sulfonylureas (SU) (207186), respectively.

The probability of 3-point MACEs experienced by subjects treated with DPP4i, GLP-1RA, SGLT2i, or Sulfonylureas (SU) defined as non-fatal myocardial infarction (MI), non-fatal stroke, and mortality. The probability was calculated and reported as the hazard ratio.

Outcome measures

Outcome measures
Measure
Aims 1, 2B, and 3 Groups
n=380352 Participants
De-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D) were utilized to identify adults (≥21 years) with T2D (established using validated Healthcare Effectiveness Data and Information Set criteria) who first filled any study drug GLP-1RA, SGLT2i, DPP-4i, or SU between 1/1/2014-12/31/2021. The arm was exempt from Mayo Clinic Institutional Review Board review and informed consent requirements were not applicable as this arm used deidentified administrative claims data. Glucagon like peptide 1 receptor agonist: Patients in the data who filled a glucagon-like peptide-1 receptor agonist medication Sodium-glucose cotransporter 2 inhibitor: Patients in the data who filled a sodium-glucose cotransporter 2 inhibitor Dipeptidyl Peptidase 4 Inhibitor: Patients in the data who filled a dipeptidyl peptidase-4 inhibitor Sulfonylurea: Patients in the data who filled a sulfonylurea
3-point Major Adverse Cardiovascular Event (MACE)
GLP-1RA versus DPP4i
0.87 Hazard Ratio
Interval 0.82 to 0.93
3-point Major Adverse Cardiovascular Event (MACE)
SGLT2i versus DPP4i
0.85 Hazard Ratio
Interval 0.81 to 0.9
3-point Major Adverse Cardiovascular Event (MACE)
SU versus DPP4i
1.19 Hazard Ratio
Interval 1.16 to 1.22
3-point Major Adverse Cardiovascular Event (MACE)
SGLT2i versus GLP-1RA
0.97 Hazard Ratio
Interval 0.9 to 1.05
3-point Major Adverse Cardiovascular Event (MACE)
SU versus GLP-1RA
1.36 Hazard Ratio
Interval 1.28 to 1.46
3-point Major Adverse Cardiovascular Event (MACE)
SU versus SGLT2i
1.40 Hazard Ratio
Interval 1.33 to 1.47

PRIMARY outcome

Timeframe: Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period

Population: 380352 total participants were analyzed. Those 380352 participants were further broken down into the following categories DPP4i (82438), GLP-1RA (44255), SGLT2i (46473), Sulfonylureas (SU) (207186), respectively.

The probability of 3-point MACEs (non-fatal MI, non-fatal stroke, mortality) plus heart failure hospitalization and revascularization procedure events experienced by subjects treated with DPP4i, GLP-1RA, SGLT2i, or Sulfonylureas (SU). The probability was calculated and reported as the hazard ratio.

Outcome measures

Outcome measures
Measure
Aims 1, 2B, and 3 Groups
n=380352 Participants
De-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D) were utilized to identify adults (≥21 years) with T2D (established using validated Healthcare Effectiveness Data and Information Set criteria) who first filled any study drug GLP-1RA, SGLT2i, DPP-4i, or SU between 1/1/2014-12/31/2021. The arm was exempt from Mayo Clinic Institutional Review Board review and informed consent requirements were not applicable as this arm used deidentified administrative claims data. Glucagon like peptide 1 receptor agonist: Patients in the data who filled a glucagon-like peptide-1 receptor agonist medication Sodium-glucose cotransporter 2 inhibitor: Patients in the data who filled a sodium-glucose cotransporter 2 inhibitor Dipeptidyl Peptidase 4 Inhibitor: Patients in the data who filled a dipeptidyl peptidase-4 inhibitor Sulfonylurea: Patients in the data who filled a sulfonylurea
Expanded Major Adverse Cardiovascular Events (MACE) and Its Components
GLP-1RA versus DPP4i
0.95 Hazard Ratio
Interval 0.91 to 1.0
Expanded Major Adverse Cardiovascular Events (MACE) and Its Components
SGLT2i versus DPP4i
0.93 Hazard Ratio
Interval 0.89 to 0.96
Expanded Major Adverse Cardiovascular Events (MACE) and Its Components
SU versus DPP4i
1.14 Hazard Ratio
Interval 1.12 to 1.17
Expanded Major Adverse Cardiovascular Events (MACE) and Its Components
SGLT2i versus GLP-1RA
0.97 Hazard Ratio
Interval 0.92 to 1.02
Expanded Major Adverse Cardiovascular Events (MACE) and Its Components
SU versus GLP-1RA
1.20 Hazard Ratio
Interval 1.15 to 1.26
Expanded Major Adverse Cardiovascular Events (MACE) and Its Components
SU versus SGLT2i
1.24 Hazard Ratio
Interval 1.2 to 1.28

PRIMARY outcome

Timeframe: 1 hour

Patients ranked treatment outcomes using a participatory ranking questionnaire. The questionnaire included a list of 16 health outcomes and eight medication attributes, with opportunities for participants to add outcomes and attributes into the ranking lists. During the exercise, participants were asked to assign each outcome and attribute to one of three mutually exclusive categories: "very important," "somewhat important," or "not very important," based on the degree to which each outcome or attribute would influence their choice of medication. Results shown below reflect the health outcomes/medication attributes that were ranked "very important" by patients.

Outcome measures

Outcome measures
Measure
Aims 1, 2B, and 3 Groups
n=25 Participants
De-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D) were utilized to identify adults (≥21 years) with T2D (established using validated Healthcare Effectiveness Data and Information Set criteria) who first filled any study drug GLP-1RA, SGLT2i, DPP-4i, or SU between 1/1/2014-12/31/2021. The arm was exempt from Mayo Clinic Institutional Review Board review and informed consent requirements were not applicable as this arm used deidentified administrative claims data. Glucagon like peptide 1 receptor agonist: Patients in the data who filled a glucagon-like peptide-1 receptor agonist medication Sodium-glucose cotransporter 2 inhibitor: Patients in the data who filled a sodium-glucose cotransporter 2 inhibitor Dipeptidyl Peptidase 4 Inhibitor: Patients in the data who filled a dipeptidyl peptidase-4 inhibitor Sulfonylurea: Patients in the data who filled a sulfonylurea
Patient Preferences for Second-line Type 2 Diabetes Medication Treatment Outcomes
Serious Infection
2 Participants
Patient Preferences for Second-line Type 2 Diabetes Medication Treatment Outcomes
Being admitted
2 Participants
Patient Preferences for Second-line Type 2 Diabetes Medication Treatment Outcomes
Pancreatitis
3 Participants
Patient Preferences for Second-line Type 2 Diabetes Medication Treatment Outcomes
Issues with your feet
4 Participants
Patient Preferences for Second-line Type 2 Diabetes Medication Treatment Outcomes
Eye Issues
4 Participants
Patient Preferences for Second-line Type 2 Diabetes Medication Treatment Outcomes
Worsening Kidney Function
4 Participants
Patient Preferences for Second-line Type 2 Diabetes Medication Treatment Outcomes
Very low blood sugar
4 Participants
Patient Preferences for Second-line Type 2 Diabetes Medication Treatment Outcomes
Cancer
7 Participants
Patient Preferences for Second-line Type 2 Diabetes Medication Treatment Outcomes
Vessel Blockages
7 Participants
Patient Preferences for Second-line Type 2 Diabetes Medication Treatment Outcomes
Stroke
7 Participants
Patient Preferences for Second-line Type 2 Diabetes Medication Treatment Outcomes
Amputation
10 Participants
Patient Preferences for Second-line Type 2 Diabetes Medication Treatment Outcomes
Heart Attack
10 Participants
Patient Preferences for Second-line Type 2 Diabetes Medication Treatment Outcomes
End Stage Kidney Disease (ESKD)
11 Participants
Patient Preferences for Second-line Type 2 Diabetes Medication Treatment Outcomes
Death
12 Participants
Patient Preferences for Second-line Type 2 Diabetes Medication Treatment Outcomes
Heart Failure
13 Participants
Patient Preferences for Second-line Type 2 Diabetes Medication Treatment Outcomes
Blindness
16 Participants

SECONDARY outcome

Timeframe: Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period

Population: 380352 total participants were analyzed. Those 380352 participants were further broken down into the following categories DPP4i (82438), GLP-1RA (44255), SGLT2i (46473), Sulfonylureas (SU) (207186), respectively.

The probability of a non-fatal MI experienced by subjects treated with DPP4i, GLP-1RA, SGLT2i, or Sulfonylureas (SU). The probability was calculated and reported as the hazard ratio.

Outcome measures

Outcome measures
Measure
Aims 1, 2B, and 3 Groups
n=380352 Participants
De-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D) were utilized to identify adults (≥21 years) with T2D (established using validated Healthcare Effectiveness Data and Information Set criteria) who first filled any study drug GLP-1RA, SGLT2i, DPP-4i, or SU between 1/1/2014-12/31/2021. The arm was exempt from Mayo Clinic Institutional Review Board review and informed consent requirements were not applicable as this arm used deidentified administrative claims data. Glucagon like peptide 1 receptor agonist: Patients in the data who filled a glucagon-like peptide-1 receptor agonist medication Sodium-glucose cotransporter 2 inhibitor: Patients in the data who filled a sodium-glucose cotransporter 2 inhibitor Dipeptidyl Peptidase 4 Inhibitor: Patients in the data who filled a dipeptidyl peptidase-4 inhibitor Sulfonylurea: Patients in the data who filled a sulfonylurea
Non-fatal Myocardial Infarction (MI)
GLP-1RA versus DPP4i
0.89 Hazard Ratio
Interval 0.78 to 1.01
Non-fatal Myocardial Infarction (MI)
SGLT2i versus DPP4i
0.93 Hazard Ratio
Interval 0.85 to 1.02
Non-fatal Myocardial Infarction (MI)
SU versus DPP4i
1.21 Hazard Ratio
Interval 1.15 to 1.26
Non-fatal Myocardial Infarction (MI)
SGLT2i versus GLP-1RA
1.05 Hazard Ratio
Interval 0.91 to 1.21
Non-fatal Myocardial Infarction (MI)
SU versus GLP-1RA
1.35 Hazard Ratio
Interval 1.2 to 1.53
Non-fatal Myocardial Infarction (MI)
SU versus SGLT2i
1.30 Hazard Ratio
Interval 1.19 to 1.41

SECONDARY outcome

Timeframe: Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period

Population: 380352 total participants were analyzed. Those 380352 participants were further broken down into the following categories DPP4i (82438), GLP-1RA (44255), SGLT2i (46473), Sulfonylureas (SU) (207186), respectively.

The probability of non-fatal stroke events experienced by subjects treated with DPP4i, GLP-1RA, SGLT2i, or Sulfonylureas (SU). The probability was calculated and reported as the hazard ratio.

Outcome measures

Outcome measures
Measure
Aims 1, 2B, and 3 Groups
n=380352 Participants
De-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D) were utilized to identify adults (≥21 years) with T2D (established using validated Healthcare Effectiveness Data and Information Set criteria) who first filled any study drug GLP-1RA, SGLT2i, DPP-4i, or SU between 1/1/2014-12/31/2021. The arm was exempt from Mayo Clinic Institutional Review Board review and informed consent requirements were not applicable as this arm used deidentified administrative claims data. Glucagon like peptide 1 receptor agonist: Patients in the data who filled a glucagon-like peptide-1 receptor agonist medication Sodium-glucose cotransporter 2 inhibitor: Patients in the data who filled a sodium-glucose cotransporter 2 inhibitor Dipeptidyl Peptidase 4 Inhibitor: Patients in the data who filled a dipeptidyl peptidase-4 inhibitor Sulfonylurea: Patients in the data who filled a sulfonylurea
Non-fatal Stroke Events
GLP-1RA versus DPP4i
0.89 Hazard Ratio
Interval 0.78 to 1.02
Non-fatal Stroke Events
SGLT2i versus DPP4i
0.89 Hazard Ratio
Interval 0.81 to 0.98
Non-fatal Stroke Events
SU versus DPP4i
1.18 Hazard Ratio
Interval 1.13 to 1.24
Non-fatal Stroke Events
SGLT2i versus GLP-1RA
1.00 Hazard Ratio
Interval 0.86 to 1.16
Non-fatal Stroke Events
SU versus GLP-1RA
1.33 Hazard Ratio
Interval 1.17 to 1.5
Non-fatal Stroke Events
SU versus SGLT2i
1.33 Hazard Ratio
Interval 1.22 to 1.45

SECONDARY outcome

Timeframe: Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period

Population: 380352 total participants were analyzed. Those 380352 participants were further broken down into the following categories DPP4i (82438), GLP-1RA (44255), SGLT2i (46473), Sulfonylureas (SU) (207186), respectively.

The probability of all-cause mortality events experienced by subjects treated with DPP4i, GLP-1RA, SGLT2i, Sulfonylureas (SU). The probability was calculated and reported as the hazard ratio.

Outcome measures

Outcome measures
Measure
Aims 1, 2B, and 3 Groups
n=380352 Participants
De-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D) were utilized to identify adults (≥21 years) with T2D (established using validated Healthcare Effectiveness Data and Information Set criteria) who first filled any study drug GLP-1RA, SGLT2i, DPP-4i, or SU between 1/1/2014-12/31/2021. The arm was exempt from Mayo Clinic Institutional Review Board review and informed consent requirements were not applicable as this arm used deidentified administrative claims data. Glucagon like peptide 1 receptor agonist: Patients in the data who filled a glucagon-like peptide-1 receptor agonist medication Sodium-glucose cotransporter 2 inhibitor: Patients in the data who filled a sodium-glucose cotransporter 2 inhibitor Dipeptidyl Peptidase 4 Inhibitor: Patients in the data who filled a dipeptidyl peptidase-4 inhibitor Sulfonylurea: Patients in the data who filled a sulfonylurea
All-cause Mortality
GLP-1RA versus DPP4i
0.86 Hazard Ratio
Interval 0.78 to 0.94
All-cause Mortality
SGLT2i versus DPP4i
0.79 Hazard Ratio
Interval 0.73 to 0.85
All-cause Mortality
SU versus DPP4i
1.22 Hazard Ratio
Interval 1.18 to 1.26
All-cause Mortality
SGLT2i versus GLP-1RA
0.92 Hazard Ratio
Interval 0.82 to 1.03
All-cause Mortality
SU versus GLP-1RA
1.42 Hazard Ratio
Interval 1.3 to 1.56
All-cause Mortality
SU versus SGLT2i
1.55 Hazard Ratio
Interval 1.44 to 1.66

SECONDARY outcome

Timeframe: Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period

Population: 380352 total participants were analyzed. Those 380352 participants were further broken down into the following categories DPP4i (82438), GLP-1RA (44255), SGLT2i (46473), Sulfonylureas (SU) (207186), respectively.

The probability of emergency department visits or hospitalization for hypoglycemia experienced by subjects treated with DPP4i, GLP-1RA, SGLT2i, or Sulfonylurea (SU). The probability was calculated and reported as the hazard ratio.

Outcome measures

Outcome measures
Measure
Aims 1, 2B, and 3 Groups
n=380352 Participants
De-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D) were utilized to identify adults (≥21 years) with T2D (established using validated Healthcare Effectiveness Data and Information Set criteria) who first filled any study drug GLP-1RA, SGLT2i, DPP-4i, or SU between 1/1/2014-12/31/2021. The arm was exempt from Mayo Clinic Institutional Review Board review and informed consent requirements were not applicable as this arm used deidentified administrative claims data. Glucagon like peptide 1 receptor agonist: Patients in the data who filled a glucagon-like peptide-1 receptor agonist medication Sodium-glucose cotransporter 2 inhibitor: Patients in the data who filled a sodium-glucose cotransporter 2 inhibitor Dipeptidyl Peptidase 4 Inhibitor: Patients in the data who filled a dipeptidyl peptidase-4 inhibitor Sulfonylurea: Patients in the data who filled a sulfonylurea
Severe Hypoglycemia
GLP-1RA versus DPP4i
0.63 Hazard Ratio
Interval 0.51 to 0.76
Severe Hypoglycemia
SGLT2i versus DPP4i
0.56 Hazard Ratio
Interval 0.46 to 0.68
Severe Hypoglycemia
SU versus DPP4i
2.51 Hazard Ratio
Interval 2.29 to 2.75
Severe Hypoglycemia
SGLT2i versus GLP-1RA
0.90 Hazard Ratio
Interval 0.7 to 1.16
Severe Hypoglycemia
SU versus GLP-1RA
4.00 Hazard Ratio
Interval 3.32 to 4.85
Severe Hypoglycemia
SU versus SGLT2i
4.46 Hazard Ratio
Interval 3.73 to 5.32

SECONDARY outcome

Timeframe: Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period

Population: 367452 total participants were analyzed. Those 367452 participants were further broken down into the following categories DPP4i (77042), GLP-1RA (42009), SGLT2i (53435), Sulfonylureas (SU) (194966), respectively.

The probability of a new diagnosis of stage 5 or end-stage kidney disease experienced by subjects treated with DPP4i, GLP-1RA, SGLT2i, or Sulfonylurea (SU). The probability was calculated and reported as the hazard ratio.

Outcome measures

Outcome measures
Measure
Aims 1, 2B, and 3 Groups
n=367452 Participants
De-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D) were utilized to identify adults (≥21 years) with T2D (established using validated Healthcare Effectiveness Data and Information Set criteria) who first filled any study drug GLP-1RA, SGLT2i, DPP-4i, or SU between 1/1/2014-12/31/2021. The arm was exempt from Mayo Clinic Institutional Review Board review and informed consent requirements were not applicable as this arm used deidentified administrative claims data. Glucagon like peptide 1 receptor agonist: Patients in the data who filled a glucagon-like peptide-1 receptor agonist medication Sodium-glucose cotransporter 2 inhibitor: Patients in the data who filled a sodium-glucose cotransporter 2 inhibitor Dipeptidyl Peptidase 4 Inhibitor: Patients in the data who filled a dipeptidyl peptidase-4 inhibitor Sulfonylurea: Patients in the data who filled a sulfonylurea
Incident End-stage Kidney Disease
SGLT2i versus DPP4i
0.65 Hazard Ratio
Interval 0.56 to 0.76
Incident End-stage Kidney Disease
GLP-1RA versus DPP4i
0.81 Hazard Ratio
Interval 0.66 to 0.99
Incident End-stage Kidney Disease
SU versus DPP4i
1.01 Hazard Ratio
Interval 0.93 to 1.08
Incident End-stage Kidney Disease
SGLT2i versus SU
0.65 Hazard Ratio
Interval 0.56 to 0.75
Incident End-stage Kidney Disease
GLP-1RA versus SU
0.80 Hazard Ratio
Interval 0.66 to 0.97
Incident End-stage Kidney Disease
SGLT2i versus GLP-1RA
0.81 Hazard Ratio
Interval 0.64 to 1.02

SECONDARY outcome

Timeframe: Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period

Population: 371698 total participants were analyzed. Those 371698 participants were further broken down into the following categories DPP4i (78444), GLP-1RA (42265), SGLT2i (53476), Sulfonylureas (SU) (197513), respectively.

The probability of treatment for diabetic retinopathy and/or macular edema experienced by subjects treated with DPP4i, GLP-1RA, SGLT2i, or Sulfonylurea (SU). The probability was calculated and reported as the hazard ratio.

Outcome measures

Outcome measures
Measure
Aims 1, 2B, and 3 Groups
n=371698 Participants
De-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D) were utilized to identify adults (≥21 years) with T2D (established using validated Healthcare Effectiveness Data and Information Set criteria) who first filled any study drug GLP-1RA, SGLT2i, DPP-4i, or SU between 1/1/2014-12/31/2021. The arm was exempt from Mayo Clinic Institutional Review Board review and informed consent requirements were not applicable as this arm used deidentified administrative claims data. Glucagon like peptide 1 receptor agonist: Patients in the data who filled a glucagon-like peptide-1 receptor agonist medication Sodium-glucose cotransporter 2 inhibitor: Patients in the data who filled a sodium-glucose cotransporter 2 inhibitor Dipeptidyl Peptidase 4 Inhibitor: Patients in the data who filled a dipeptidyl peptidase-4 inhibitor Sulfonylurea: Patients in the data who filled a sulfonylurea
Treatment for Diabetic Retinopathy or Macular Edema
SGLT2i versus GLP-1RA
0.73 Hazard Ratio
Interval 0.55 to 0.97
Treatment for Diabetic Retinopathy or Macular Edema
SGLT2i versus DPP4i
0.79 Hazard Ratio
Interval 0.64 to 0.97
Treatment for Diabetic Retinopathy or Macular Edema
SGLT2i versus SU
0.61 Hazard Ratio
Interval 0.5 to 0.74
Treatment for Diabetic Retinopathy or Macular Edema
GLP-1RA versus DPP4i
1.07 Hazard Ratio
Interval 0.85 to 1.35
Treatment for Diabetic Retinopathy or Macular Edema
GLP-1RA versus SU
0.83 Hazard Ratio
Interval 0.67 to 1.03
Treatment for Diabetic Retinopathy or Macular Edema
SU versus DPP4i
1.29 Hazard Ratio
Interval 1.17 to 1.42

SECONDARY outcome

Timeframe: Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period

Population: 384451 total participants were analyzed. Those 384451 participants were further broken down into the following categories DPP4i (83937), GLP-1RA (43947), SGLT2i (46926), Sulfonylureas (SU) (209641), respectively.

The probability of foot and/or leg amputation, osteomyelitis, ulcer, abscess or Charcot arthropathy experienced by subjects treated with DPP4i, GLP-1RA, SGLT2i, or Sulfonylurea (SU). The probability was calculated and reported as the hazard ratio.

Outcome measures

Outcome measures
Measure
Aims 1, 2B, and 3 Groups
n=384451 Participants
De-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D) were utilized to identify adults (≥21 years) with T2D (established using validated Healthcare Effectiveness Data and Information Set criteria) who first filled any study drug GLP-1RA, SGLT2i, DPP-4i, or SU between 1/1/2014-12/31/2021. The arm was exempt from Mayo Clinic Institutional Review Board review and informed consent requirements were not applicable as this arm used deidentified administrative claims data. Glucagon like peptide 1 receptor agonist: Patients in the data who filled a glucagon-like peptide-1 receptor agonist medication Sodium-glucose cotransporter 2 inhibitor: Patients in the data who filled a sodium-glucose cotransporter 2 inhibitor Dipeptidyl Peptidase 4 Inhibitor: Patients in the data who filled a dipeptidyl peptidase-4 inhibitor Sulfonylurea: Patients in the data who filled a sulfonylurea
Lower Extremity Complications
SU versus DPP4i
1.15 Hazard Ratio
Interval 1.11 to 1.19
Lower Extremity Complications
SU versus GLP-1RA
1.20 Hazard Ratio
Interval 1.13 to 1.28
Lower Extremity Complications
SU versus SGLT2i
1.08 Hazard Ratio
Interval 1.02 to 1.14
Lower Extremity Complications
SGLT2i versus GLP-1RA
1.11 Hazard Ratio
Interval 1.03 to 1.21
Lower Extremity Complications
GLP-1RA versus DPP4i
0.96 Hazard Ratio
Interval 0.89 to 1.02
Lower Extremity Complications
SGLT2i versus DPP4i
1.07 Hazard Ratio
Interval 1.0 to 1.13

Adverse Events

Aims 1, 2B, and 3 Groups

Serious events: 40642 serious events
Other events: 62982 other events
Deaths: 22208 deaths

Aim 2A Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Aims 1, 2B, and 3 Groups
n=386276 participants at risk
De-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D) were utilized to identify adults (≥21 years) with T2D (established using validated Healthcare Effectiveness Data and Information Set criteria) who first filled any study drug GLP-1RA, SGLT2i, DPP-4i, or SU between 1/1/2014-12/31/2021. The arm was exempt from Mayo Clinic Institutional Review Board review and informed consent requirements were not applicable as this arm used deidentified administrative claims data. Glucagon like peptide 1 receptor agonist: Patients in the data who filled a glucagon-like peptide-1 receptor agonist medication Sodium-glucose cotransporter 2 inhibitor: Patients in the data who filled a sodium-glucose cotransporter 2 inhibitor Dipeptidyl Peptidase 4 Inhibitor: Patients in the data who filled a dipeptidyl peptidase-4 inhibitor Sulfonylurea: Patients in the data who filled a sulfonylurea
Aim 2A Group
n=25 participants at risk
Adults with Type 2 diabetes treated with one or more of the study medications (GLP-1RA, SGLT2i, DPP-4i, or SU) and not treated with insulin who received medical care at Mayo Clinic Rochester or Mayo Clinic Health System in Minnesota or Wisconsin. This arm was not exempt from Mayo Clinic Institutional Review Board review and informed consent requirements were applicable as this arm collected prospective data.
Cardiac disorders
Acute MI
2.9%
11372/386276 • Aims 1, 2B, and 3 Groups: Adverse events were collected from the time of first observed use of one of the four study medications (DPP4i, GLP-1RA, SGLT2i, Sulfonylurea) during the study period until either the end of the study, disenrollment from insurance plans in our database, or death (approximately 8 years), retrospective data collected over a 2-year period. Aim 2A Group: Adverse events were collected from the time of informed consent through study completion, approximately 1 hour.
Aims 1, 2B, and 3 Groups: Adverse events were collected through de-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D). Aims 2A Group: Adverse events were collected through patient interviews.
0.00%
0/25 • Aims 1, 2B, and 3 Groups: Adverse events were collected from the time of first observed use of one of the four study medications (DPP4i, GLP-1RA, SGLT2i, Sulfonylurea) during the study period until either the end of the study, disenrollment from insurance plans in our database, or death (approximately 8 years), retrospective data collected over a 2-year period. Aim 2A Group: Adverse events were collected from the time of informed consent through study completion, approximately 1 hour.
Aims 1, 2B, and 3 Groups: Adverse events were collected through de-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D). Aims 2A Group: Adverse events were collected through patient interviews.
Nervous system disorders
Acute Stroke
2.8%
10647/386276 • Aims 1, 2B, and 3 Groups: Adverse events were collected from the time of first observed use of one of the four study medications (DPP4i, GLP-1RA, SGLT2i, Sulfonylurea) during the study period until either the end of the study, disenrollment from insurance plans in our database, or death (approximately 8 years), retrospective data collected over a 2-year period. Aim 2A Group: Adverse events were collected from the time of informed consent through study completion, approximately 1 hour.
Aims 1, 2B, and 3 Groups: Adverse events were collected through de-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D). Aims 2A Group: Adverse events were collected through patient interviews.
0.00%
0/25 • Aims 1, 2B, and 3 Groups: Adverse events were collected from the time of first observed use of one of the four study medications (DPP4i, GLP-1RA, SGLT2i, Sulfonylurea) during the study period until either the end of the study, disenrollment from insurance plans in our database, or death (approximately 8 years), retrospective data collected over a 2-year period. Aim 2A Group: Adverse events were collected from the time of informed consent through study completion, approximately 1 hour.
Aims 1, 2B, and 3 Groups: Adverse events were collected through de-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D). Aims 2A Group: Adverse events were collected through patient interviews.
Cardiac disorders
Heart Failure Hospitalization
2.7%
10455/386276 • Aims 1, 2B, and 3 Groups: Adverse events were collected from the time of first observed use of one of the four study medications (DPP4i, GLP-1RA, SGLT2i, Sulfonylurea) during the study period until either the end of the study, disenrollment from insurance plans in our database, or death (approximately 8 years), retrospective data collected over a 2-year period. Aim 2A Group: Adverse events were collected from the time of informed consent through study completion, approximately 1 hour.
Aims 1, 2B, and 3 Groups: Adverse events were collected through de-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D). Aims 2A Group: Adverse events were collected through patient interviews.
0.00%
0/25 • Aims 1, 2B, and 3 Groups: Adverse events were collected from the time of first observed use of one of the four study medications (DPP4i, GLP-1RA, SGLT2i, Sulfonylurea) during the study period until either the end of the study, disenrollment from insurance plans in our database, or death (approximately 8 years), retrospective data collected over a 2-year period. Aim 2A Group: Adverse events were collected from the time of informed consent through study completion, approximately 1 hour.
Aims 1, 2B, and 3 Groups: Adverse events were collected through de-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D). Aims 2A Group: Adverse events were collected through patient interviews.
Renal and urinary disorders
Chronic Kidney Disease Stage 5 or ESKD
2.4%
9216/386276 • Aims 1, 2B, and 3 Groups: Adverse events were collected from the time of first observed use of one of the four study medications (DPP4i, GLP-1RA, SGLT2i, Sulfonylurea) during the study period until either the end of the study, disenrollment from insurance plans in our database, or death (approximately 8 years), retrospective data collected over a 2-year period. Aim 2A Group: Adverse events were collected from the time of informed consent through study completion, approximately 1 hour.
Aims 1, 2B, and 3 Groups: Adverse events were collected through de-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D). Aims 2A Group: Adverse events were collected through patient interviews.
0.00%
0/25 • Aims 1, 2B, and 3 Groups: Adverse events were collected from the time of first observed use of one of the four study medications (DPP4i, GLP-1RA, SGLT2i, Sulfonylurea) during the study period until either the end of the study, disenrollment from insurance plans in our database, or death (approximately 8 years), retrospective data collected over a 2-year period. Aim 2A Group: Adverse events were collected from the time of informed consent through study completion, approximately 1 hour.
Aims 1, 2B, and 3 Groups: Adverse events were collected through de-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D). Aims 2A Group: Adverse events were collected through patient interviews.
Metabolism and nutrition disorders
Hypoglycemia
1.1%
4282/386276 • Aims 1, 2B, and 3 Groups: Adverse events were collected from the time of first observed use of one of the four study medications (DPP4i, GLP-1RA, SGLT2i, Sulfonylurea) during the study period until either the end of the study, disenrollment from insurance plans in our database, or death (approximately 8 years), retrospective data collected over a 2-year period. Aim 2A Group: Adverse events were collected from the time of informed consent through study completion, approximately 1 hour.
Aims 1, 2B, and 3 Groups: Adverse events were collected through de-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D). Aims 2A Group: Adverse events were collected through patient interviews.
0.00%
0/25 • Aims 1, 2B, and 3 Groups: Adverse events were collected from the time of first observed use of one of the four study medications (DPP4i, GLP-1RA, SGLT2i, Sulfonylurea) during the study period until either the end of the study, disenrollment from insurance plans in our database, or death (approximately 8 years), retrospective data collected over a 2-year period. Aim 2A Group: Adverse events were collected from the time of informed consent through study completion, approximately 1 hour.
Aims 1, 2B, and 3 Groups: Adverse events were collected through de-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D). Aims 2A Group: Adverse events were collected through patient interviews.
Injury, poisoning and procedural complications
Amputation
1.2%
4661/386276 • Aims 1, 2B, and 3 Groups: Adverse events were collected from the time of first observed use of one of the four study medications (DPP4i, GLP-1RA, SGLT2i, Sulfonylurea) during the study period until either the end of the study, disenrollment from insurance plans in our database, or death (approximately 8 years), retrospective data collected over a 2-year period. Aim 2A Group: Adverse events were collected from the time of informed consent through study completion, approximately 1 hour.
Aims 1, 2B, and 3 Groups: Adverse events were collected through de-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D). Aims 2A Group: Adverse events were collected through patient interviews.
0.00%
0/25 • Aims 1, 2B, and 3 Groups: Adverse events were collected from the time of first observed use of one of the four study medications (DPP4i, GLP-1RA, SGLT2i, Sulfonylurea) during the study period until either the end of the study, disenrollment from insurance plans in our database, or death (approximately 8 years), retrospective data collected over a 2-year period. Aim 2A Group: Adverse events were collected from the time of informed consent through study completion, approximately 1 hour.
Aims 1, 2B, and 3 Groups: Adverse events were collected through de-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D). Aims 2A Group: Adverse events were collected through patient interviews.

Other adverse events

Other adverse events
Measure
Aims 1, 2B, and 3 Groups
n=386276 participants at risk
De-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D) were utilized to identify adults (≥21 years) with T2D (established using validated Healthcare Effectiveness Data and Information Set criteria) who first filled any study drug GLP-1RA, SGLT2i, DPP-4i, or SU between 1/1/2014-12/31/2021. The arm was exempt from Mayo Clinic Institutional Review Board review and informed consent requirements were not applicable as this arm used deidentified administrative claims data. Glucagon like peptide 1 receptor agonist: Patients in the data who filled a glucagon-like peptide-1 receptor agonist medication Sodium-glucose cotransporter 2 inhibitor: Patients in the data who filled a sodium-glucose cotransporter 2 inhibitor Dipeptidyl Peptidase 4 Inhibitor: Patients in the data who filled a dipeptidyl peptidase-4 inhibitor Sulfonylurea: Patients in the data who filled a sulfonylurea
Aim 2A Group
n=25 participants at risk
Adults with Type 2 diabetes treated with one or more of the study medications (GLP-1RA, SGLT2i, DPP-4i, or SU) and not treated with insulin who received medical care at Mayo Clinic Rochester or Mayo Clinic Health System in Minnesota or Wisconsin. This arm was not exempt from Mayo Clinic Institutional Review Board review and informed consent requirements were applicable as this arm collected prospective data.
Cardiac disorders
Revascularization Procedure
11.0%
42514/386276 • Aims 1, 2B, and 3 Groups: Adverse events were collected from the time of first observed use of one of the four study medications (DPP4i, GLP-1RA, SGLT2i, Sulfonylurea) during the study period until either the end of the study, disenrollment from insurance plans in our database, or death (approximately 8 years), retrospective data collected over a 2-year period. Aim 2A Group: Adverse events were collected from the time of informed consent through study completion, approximately 1 hour.
Aims 1, 2B, and 3 Groups: Adverse events were collected through de-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D). Aims 2A Group: Adverse events were collected through patient interviews.
0.00%
0/25 • Aims 1, 2B, and 3 Groups: Adverse events were collected from the time of first observed use of one of the four study medications (DPP4i, GLP-1RA, SGLT2i, Sulfonylurea) during the study period until either the end of the study, disenrollment from insurance plans in our database, or death (approximately 8 years), retrospective data collected over a 2-year period. Aim 2A Group: Adverse events were collected from the time of informed consent through study completion, approximately 1 hour.
Aims 1, 2B, and 3 Groups: Adverse events were collected through de-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D). Aims 2A Group: Adverse events were collected through patient interviews.
Injury, poisoning and procedural complications
Lower Extremity Complication
5.6%
21466/386276 • Aims 1, 2B, and 3 Groups: Adverse events were collected from the time of first observed use of one of the four study medications (DPP4i, GLP-1RA, SGLT2i, Sulfonylurea) during the study period until either the end of the study, disenrollment from insurance plans in our database, or death (approximately 8 years), retrospective data collected over a 2-year period. Aim 2A Group: Adverse events were collected from the time of informed consent through study completion, approximately 1 hour.
Aims 1, 2B, and 3 Groups: Adverse events were collected through de-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D). Aims 2A Group: Adverse events were collected through patient interviews.
0.00%
0/25 • Aims 1, 2B, and 3 Groups: Adverse events were collected from the time of first observed use of one of the four study medications (DPP4i, GLP-1RA, SGLT2i, Sulfonylurea) during the study period until either the end of the study, disenrollment from insurance plans in our database, or death (approximately 8 years), retrospective data collected over a 2-year period. Aim 2A Group: Adverse events were collected from the time of informed consent through study completion, approximately 1 hour.
Aims 1, 2B, and 3 Groups: Adverse events were collected through de-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D). Aims 2A Group: Adverse events were collected through patient interviews.
Eye disorders
Treatment for Retinopathy
1.3%
4934/386276 • Aims 1, 2B, and 3 Groups: Adverse events were collected from the time of first observed use of one of the four study medications (DPP4i, GLP-1RA, SGLT2i, Sulfonylurea) during the study period until either the end of the study, disenrollment from insurance plans in our database, or death (approximately 8 years), retrospective data collected over a 2-year period. Aim 2A Group: Adverse events were collected from the time of informed consent through study completion, approximately 1 hour.
Aims 1, 2B, and 3 Groups: Adverse events were collected through de-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D). Aims 2A Group: Adverse events were collected through patient interviews.
0.00%
0/25 • Aims 1, 2B, and 3 Groups: Adverse events were collected from the time of first observed use of one of the four study medications (DPP4i, GLP-1RA, SGLT2i, Sulfonylurea) during the study period until either the end of the study, disenrollment from insurance plans in our database, or death (approximately 8 years), retrospective data collected over a 2-year period. Aim 2A Group: Adverse events were collected from the time of informed consent through study completion, approximately 1 hour.
Aims 1, 2B, and 3 Groups: Adverse events were collected through de-identified administrative claims with linked laboratory results, electronic health record (EHR), and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data (Medicare parts A, B, D). Aims 2A Group: Adverse events were collected through patient interviews.

Additional Information

Rozalina McCoy, M.D., M.S.

Mayo Clinic

Phone: 507-538-7955

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place