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.
COMPLETED
386301 participants
Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period
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
| 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
| 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
| 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 periodPopulation: 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
| 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 periodPopulation: 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
| 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 hourPatients 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
| 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 periodPopulation: 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
| 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 periodPopulation: 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
| 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 periodPopulation: 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
| 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 periodPopulation: 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
| 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 periodPopulation: 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
| 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 periodPopulation: 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
| 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 periodPopulation: 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
| 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
Aim 2A Group
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
| 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place