Type 2 DiabetesNCT05214573
Second-line Therapies for Patients With Type 2 Diabetes and Moderate Cardiovascular Disease Risk
An observational study of Type 2 Diabetes and Cardiac Disease, run by Mayo Clinic at 1 site in United States.
Trial summary
We will use the target trial framework for causal inference to conduct this observational retrospective cohort study that uses claims data of adults with type 2 diabetes (T2D) included in the de-identified datasets of OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Type 2 Diabetes, Cardiac Disease
- What is being tested?
- Glucagon like peptide 1 receptor agonist, Sodium-glucose cotransporter 2 inhibitor and Dipeptidyl Peptidase 4 Inhibitor
- How many people
- 386,301 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 22 Jul 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Aims 1, 2B, 3: De-identified data sets using laboratory results, electronic health record and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data. Aim 2A: Adults with Type 2 diabetes receiving care from primary care and endocrinology practices in Mayo Clinic Rochester, MN or Mayo Clinic Health System in Minnesota and Wisconsin.
Who may be able to join
- ≥ 21 years old.
- Diagnosis of Type 2 diabetes.
- Use of ≥ 1 study drug (GLP-1RA, SGLT2i, DPP-4i, SU).
Who cannot join
- Fill for any study drug during the baseline period or simultaneous (within 30 days) start of ≥2 study drugs
- Insulin use
- Type 1 diabetes
- High risk of CVD
- Pregnancy
- Metastatic cancer
Show all 11Show fewer
- Insulin use.
- Cognitive impairment.
- Terminal or advanced illness.
- Non-English speaking.
- Residency in a long-term care setting.
Trial locations and contacts
1 site in 1 country.
About this study
We will use the target trial framework for causal inference to conduct this observational retrospective cohort study that uses claims data of adults with type 2 diabetes (T2D) included in the de-identified datasets of OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service.
In Aim 1, we will emulate a target trial comparing the effectiveness of glucagon-like peptide-1 receptor agonists (GLP-1RA), sodium-glucose cotransporter 2 inhibitors (SGLT2i), dipeptidyl peptidase-4 inhibitors (DPP-4i), and sulfonylureas (SU) in adults with T2D at moderate risk of cardiovascular disease (CVD) with regard to major adverse cardiovascular events (MACE), expanded MACE, microvascular complications, severe hypoglycemia, and other adverse events.
Read more
In Aim 2, we will compare these four drug classes in the same population of adults with T2D included in OLDW and Medicare fee-for-service data with respect to a set of composite outcomes identified by a group of patients with T2D as being most important to them. Specifically, in Aim 2A, we will prospectively elicit patient preferences toward various treatment outcomes (e.g., hospitalization, kidney disease) using a participatory ranking exercise, then use these rankings to generate individually weighted composite outcomes. Then, in Aim 2B, we will estimate patient-centered treatment effects of four different second-line T2D medications that reflect the patient's value for each outcome.
In Aim 3, we will compare different medications within each of the four therapeutic classes with respect to MACE.
Read the detailed description
Study Design: We will use the target trial framework for causal inference to conduct this observational cohort study.
Comparators: Aims 1-2 compare the GLP-1RA, SGLT2i, DPP-4i, and SU classes, while Aim 3 compares the individual drugs within each therapeutic class.
Population: Using data from OptumLabs Data Warehouse linked to 100% Medicare FFS claims, we will identify adults (≥21 years) with T2D at moderate risk for CVD who started a GLP-1RA, SGLT2i, DPP-4i, or SU
Outcomes: In AIMs 1 and 3, the primary outcome will be time to MACE (non-fatal MI, non-fatal stroke, all-cause mortality). Secondary outcomes will include times to expanded MACE (MACE, HF hospitalizations, revascularization procedures) and its components, lower extremity complications, severe hypoglycemia, microvascular complications, and other significant adverse events. In AIM 2A, we will elicit patient preferences toward various treatment outcomes using a participatory ranking exercise, use these rankings to generate individually weighted composite outcomes, and then estimate patient-centered treatment effects of GLP-1RA, SGLT2i, DPP4i, and SU reflecting the patient values for each of the outcomes.
Timeframe: January 1, 2014 to December 31, 2021.
Methods: Inverse probability weighting will be used to emulate baseline randomization for pairwise comparisons between the drug classes (AIMs 1-2) and individual drugs within each class (AIM 3). Causal cumulative incidence rates will be estimated in the weighted sample using the targeted maximum likelihood estimator adjusting for time-dependent confounding and loss-to-follow-up.
- Conditions
- Type 2 Diabetes, Cardiac Disease
- Being tested
- Glucagon like peptide 1 receptor agonist, Sodium-glucose cotransporter 2 inhibitor, Dipeptidyl Peptidase 4 Inhibitor, Sulfonylurea
- Keywords
- Diabetes, Type 2 diabetes, Cardiovascular disease, Comparative effectiveness
- Medical subject headings
- Diabetes Mellitus, Type 2, Heart Diseases, Diabetes Mellitus, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucagon like peptide 1 receptor agonistDrug
Patients in the data who filled a glucagon-like peptide-1 receptor agonist medication
Sodium-glucose cotransporter 2 inhibitorDrug
Patients in the data who filled a sodium-glucose cotransporter 2 inhibitor
Dipeptidyl Peptidase 4 InhibitorDrug
Patients in the data who filled a dipeptidyl peptidase-4 inhibitor
SulfonylureaDrug
Patients in the data who filled a sulfonylurea
| Study group | Role | What they receive |
|---|---|---|
| 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) will be 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. 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. Receives: Drug: Glucagon like peptide 1 receptor agonist; Drug: Sodium-glucose cotransporter 2 inhibitor; Drug: Dipeptidyl Peptidase 4 Inhibitor; Drug: 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 receive 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-point Major Adverse Cardiovascular Event (MACE)
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.
Measured: Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period
Expanded Major Adverse Cardiovascular Events (MACE) and Its Components
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.
Measured: Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period
Patient Preferences for Second-line Type 2 Diabetes Medication Treatment Outcomes
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.
Measured: 1 hour
Secondary outcomes (7)
Non-fatal Myocardial Infarction (MI)
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.
Measured: Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period
Non-fatal Stroke Events
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.
Measured: Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period
All-cause Mortality
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.
Measured: Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period
Severe Hypoglycemia
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.
Measured: Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period
Incident End-stage Kidney Disease
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.
Measured: Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period
Treatment for Diabetic Retinopathy or Macular Edema
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.
Measured: Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period
Lower Extremity Complications
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.
Measured: Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 Dec 2021
- Primary completion30 Sep 2023
- Study completion22 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 386,301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Rozalina G. McCoy, Mayo Clinic
- Investigators
- Rozalina McCoy, MD, MS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214573
- Sponsor's protocol ID
- 21-007688
- Status last verified
- Sep 2025
- First submitted
- 26 Jan 2022
- Last updated
- 10 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sklepinski S, Ratzki-Leewing AA, Herrin J, Swarna KS, Deng Y, Polley EC, Neumiller JJ, Galindo RJ, Umpierrez GE, Ross JS, Brito JP, Montori VM, Mickelson MM, McCoy RG. Comparative effectiveness of sulfonylureas on kidney outcomes in adults with type 2 diabetes and moderate cardiovascular risk: a target trial emulation. BMJ Open Diabetes Res Care. 2026 May 21;14(3):e005775. doi: 10.1136/bmjdrc-2025-005775.
PubMed 42167878Brito JP, Herrin J, Swarna KS, Singh Ospina NM, Montori VM, Toro-Tobon D, Umpierrez GE, Galindo RJ, Deng Y, Mickelson MM, Shao H, Polley EC, McCoy RG. GLP-1RA Use and Thyroid Cancer Risk. JAMA Otolaryngol Head Neck Surg. 2025 Mar 1;151(3):243-252. doi: 10.1001/jamaoto.2024.4852.
PubMed 39847346Neumiller JJ, Herrin J, Swarna KS, Polley EC, Galindo RJ, Umpierrez GE, Deng Y, Ross JS, Mickelson MM, McCoy RG. Kidney Outcomes with Glucagon-Like Peptide-1 Receptor Agonists, Sodium-Glucose Cotransporter 2 Inhibitors, Dipeptidyl Peptidase-4 Inhibitors, and Sulfonylureas in Type 2 Diabetes and Moderate Cardiovascular Risk. Clin J Am Soc Nephrol. 2025 Feb 1;20(2):206-217. doi: 10.2215/CJN.0000000587. Epub 2024 Oct 8.
PubMed 39729347McCoy RG, Herrin J, Swarna KS, Deng Y, Kent DM, Ross JS, Umpierrez GE, Galindo RJ, Crown WH, Borah BJ, Montori VM, Brito JP, Neumiller JJ, Mickelson MM, Polley EC. Effectiveness of glucose-lowering medications on cardiovascular outcomes in patients with type 2 diabetes at moderate cardiovascular risk. Nat Cardiovasc Res. 2024 Apr;3(4):431-440. doi: 10.1038/s44161-024-00453-9. Epub 2024 Apr 3.
PubMed 38846711
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second-line Therapies for Patients With Type 2 Diabetes and Moderate Cardiovascular Disease Risk
- ClinicalTrials.gov ID
- NCT05214573
- Acronym / sponsor ID
- 21-007688
- Conditions
- Type 2 Diabetes, Cardiac Disease
- Keywords
- Diabetes, Type 2 diabetes, Cardiovascular disease, Comparative effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 386,301 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 22 Jul 2025 (actual)
- First posted
- 28 Jan 2022 (actual)
- Results
- Posted 10 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We will use the target trial framework for causal inference to conduct this observational retrospective cohort study that uses claims data of adults with type 2 diabetes (T2D) included in the de-identified datasets of OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service.
In Aim 1, we will emulate a target trial comparing the effectiveness of glucagon-like peptide-1 receptor agonists (GLP-1RA), sodium-glucose cotransporter 2 inhibitors (SGLT2i), dipeptidyl peptidase-4 inhibitors (DPP-4i), and sulfonylureas (SU) in adults with T2D at moderate risk of cardiovascular disease (CVD) with regard to major adverse cardiovascular events (MACE), expanded MACE, microvascular complications, severe hypoglycemia, and other adverse events.
In Aim 2, we will compare these four drug classes in the same population of adults with T2D included in OLDW and Medicare fee-for-service data with respect to a set of composite outcomes identified by a group of patients with T2D as being most important to them. Specifically, in Aim 2A, we will prospectively elicit patient preferences toward various treatment outcomes (e.g., hospitalization, kidney disease) using a participatory ranking exercise, then use these rankings to generate individually weighted composite outcomes. Then, in Aim 2B, we will estimate patient-centered treatment effects of four different second-line T2D medications that reflect the patient's value for each outcome.
In Aim 3, we will compare different medications within each of the four therapeutic classes with respect to MACE.
Detailed description
Study Design: We will use the target trial framework for causal inference to conduct this observational cohort study.
Comparators: Aims 1-2 compare the GLP-1RA, SGLT2i, DPP-4i, and SU classes, while Aim 3 compares the individual drugs within each therapeutic class.
Population: Using data from OptumLabs Data Warehouse linked to 100% Medicare FFS claims, we will identify adults (≥21 years) with T2D at moderate risk for CVD who started a GLP-1RA, SGLT2i, DPP-4i, or SU
Outcomes: In AIMs 1 and 3, the primary outcome will be time to MACE (non-fatal MI, non-fatal stroke, all-cause mortality). Secondary outcomes will include times to expanded MACE (MACE, HF hospitalizations, revascularization procedures) and its components, lower extremity complications, severe hypoglycemia, microvascular complications, and other significant adverse events. In AIM 2A, we will elicit patient preferences toward various treatment outcomes using a participatory ranking exercise, use these rankings to generate individually weighted composite outcomes, and then estimate patient-centered treatment effects of GLP-1RA, SGLT2i, DPP4i, and SU reflecting the patient values for each of the outcomes.
Timeframe: January 1, 2014 to December 31, 2021.
Methods: Inverse probability weighting will be used to emulate baseline randomization for pairwise comparisons between the drug classes (AIMs 1-2) and individual drugs within each class (AIM 3). Causal cumulative incidence rates will be estimated in the weighted sample using the targeted maximum likelihood estimator adjusting for time-dependent confounding and loss-to-follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aims 1, 2B, and 3 Groups | – | Drug: Glucagon like peptide 1 receptor agonist, Drug: Sodium-glucose cotransporter 2 inhibitor, Drug: Dipeptidyl Peptidase 4 Inhibitor, Drug: SulfonylureaDe-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) will be 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. 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. |
| 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 receive 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Aims 1, 2B, 3: De-identified data sets using laboratory results, electronic health record and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data. Aim 2A: Adults with Type 2 diabetes receiving care from primary care and endocrinology practices in Mayo Clinic Rochester, MN or Mayo Clinic Health System in Minnesota and Wisconsin.
Key inclusion criteria (3 listed)
- ≥ 21 years old.
- Diagnosis of Type 2 diabetes.
- Use of ≥ 1 study drug (GLP-1RA, SGLT2i, DPP-4i, SU).
Key exclusion criteria (11 listed)
- Fill for any study drug during the baseline period or simultaneous (within 30 days) start of ≥2 study drugs
- Insulin use
- Type 1 diabetes
- High risk of CVD
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucagon like peptide 1 receptor agonistPatients in the data who filled a glucagon-like peptide-1 receptor agonist medication | Drug | Aims 1, 2B, and 3 Groups |
| Sodium-glucose cotransporter 2 inhibitorPatients in the data who filled a sodium-glucose cotransporter 2 inhibitor | Drug | Aims 1, 2B, and 3 Groups |
| Dipeptidyl Peptidase 4 InhibitorPatients in the data who filled a dipeptidyl peptidase-4 inhibitor | Drug | Aims 1, 2B, and 3 Groups |
| SulfonylureaPatients in the data who filled a sulfonylurea | Drug | Aims 1, 2B, and 3 Groups |
Primary outcome
3-point Major Adverse Cardiovascular Event (MACE)
Time frame: Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period
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.
Expanded Major Adverse Cardiovascular Events (MACE) and Its Components
Time frame: Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period
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.
Patient Preferences for Second-line Type 2 Diabetes Medication Treatment Outcomes
Time frame: 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.
7 secondary outcomes
Non-fatal Myocardial Infarction (MI)
Time frame: Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period
Non-fatal Stroke Events
Time frame: Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period
All-cause Mortality
Time frame: Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period
Severe Hypoglycemia
Time frame: Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period
Incident End-stage Kidney Disease
Time frame: Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period
Treatment for Diabetic Retinopathy or Macular Edema
Time frame: Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period
Lower Extremity Complications
Time frame: Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42167878Sklepinski S, Ratzki-Leewing AA, Herrin J, Swarna KS, Deng Y, Polley EC, Neumiller JJ, Galindo RJ, Umpierrez GE, Ross JS, Brito JP, Montori VM, Mickelson MM, McCoy RG. Comparative effectiveness of sulfonylureas on kidney outcomes in adults with type 2 diabetes and moderate cardiovascular risk: a target trial emulation. BMJ Open Diabetes Res Care. 2026 May 21;14(3):e005775. doi: 10.1136/bmjdrc-2025-005775.
- Derived from this study: PubMed 39847346Brito JP, Herrin J, Swarna KS, Singh Ospina NM, Montori VM, Toro-Tobon D, Umpierrez GE, Galindo RJ, Deng Y, Mickelson MM, Shao H, Polley EC, McCoy RG. GLP-1RA Use and Thyroid Cancer Risk. JAMA Otolaryngol Head Neck Surg. 2025 Mar 1;151(3):243-252. doi: 10.1001/jamaoto.2024.4852.
- Derived from this study: PubMed 39729347Neumiller JJ, Herrin J, Swarna KS, Polley EC, Galindo RJ, Umpierrez GE, Deng Y, Ross JS, Mickelson MM, McCoy RG. Kidney Outcomes with Glucagon-Like Peptide-1 Receptor Agonists, Sodium-Glucose Cotransporter 2 Inhibitors, Dipeptidyl Peptidase-4 Inhibitors, and Sulfonylureas in Type 2 Diabetes and Moderate Cardiovascular Risk. Clin J Am Soc Nephrol. 2025 Feb 1;20(2):206-217. doi: 10.2215/CJN.0000000587. Epub 2024 Oct 8.
- Derived from this study: PubMed 38846711McCoy RG, Herrin J, Swarna KS, Deng Y, Kent DM, Ross JS, Umpierrez GE, Galindo RJ, Crown WH, Borah BJ, Montori VM, Brito JP, Neumiller JJ, Mickelson MM, Polley EC. Effectiveness of glucose-lowering medications on cardiovascular outcomes in patients with type 2 diabetes at moderate cardiovascular risk. Nat Cardiovasc Res. 2024 Apr;3(4):431-440. doi: 10.1038/s44161-024-00453-9. Epub 2024 Apr 3.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rozalina McCoy, MD, MS principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Cardiac Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-point Major Adverse Cardiovascular Event (MACE) (time frame: Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05214573, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2025.