Trial · NCT05214573
Second-line Therapies for Patients With Type 2 Diabetes and Moderate Cardiovascular Disease Risk
NCT05214573, Completed, Mayo Clinic; results first posted 2025-10-10
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Second-line Therapies for Patients With Type 2 Diabetes and Moderate Cardiovascular Disease Risk. Trials, record NCT05214573. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05214573
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Second-line Therapies for Patients With Type 2 Diabetes and Moderate Cardiovascular Disease Risk
- NCT number
- NCT05214573
- Status
- Completed
- Enrollment
- 386,301 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Type 2 Diabetes, Cardiac Disease
- Interventions
- Glucagon like peptide 1 receptor agonist, Sodium-glucose cotransporter 2 inhibitor, Dipeptidyl Peptidase 4 Inhibitor, Sulfonylurea
- First posted
- 2022-01-28
- Last updated
- 2025-10-10
- Results first posted
- 2025-10-10
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 3-point Major Adverse Cardiovascular Event (MACE) | 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. |
| Primary | Expanded Major Adverse Cardiovascular Events (MACE) and Its Components | 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. |
| Primary | Patient Preferences for Second-line Type 2 Diabetes Medication Treatment Outcomes | 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. |
| Secondary | Non-fatal Myocardial Infarction (MI) | Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period | 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. |
| Secondary | Non-fatal Stroke Events | Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period | 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. |
| Secondary | All-cause Mortality | Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period | 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. |
| Secondary | Severe Hypoglycemia | Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period | 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. |
| Secondary | Incident End-stage Kidney Disease | Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period | 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. |
| Secondary | Treatment for Diabetic Retinopathy or Macular Edema | Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period | 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. |
| Secondary | Lower Extremity Complications | Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 3-point Major Adverse Cardiovascular Event (MACE) | Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period | 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. | Hazard Ratio | NUMBER |
| PRIMARY | Expanded Major Adverse Cardiovascular Events (MACE) and Its Components | Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period | 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. | Hazard Ratio | NUMBER |
| PRIMARY | Patient Preferences for Second-line Type 2 Diabetes Medication Treatment Outcomes | 1 hour | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Non-fatal Myocardial Infarction (MI) | Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period | 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. | Hazard Ratio | NUMBER |
| SECONDARY | Non-fatal Stroke Events | Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period | 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. | Hazard Ratio | NUMBER |
| SECONDARY | All-cause Mortality | Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period | 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. | Hazard Ratio | NUMBER |
| SECONDARY | Severe Hypoglycemia | Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period | 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. | Hazard Ratio | NUMBER |
| SECONDARY | Incident End-stage Kidney Disease | Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period | 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. | Hazard Ratio | NUMBER |
| SECONDARY | Treatment for Diabetic Retinopathy or Macular Edema | Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period | 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. | Hazard Ratio | NUMBER |
| SECONDARY | Lower Extremity Complications | Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period | 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. | Hazard Ratio | NUMBER |
Source ClinicalTrials.gov
Results by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 3-point Major Adverse Cardiovascular Event (MACE) | Aims 1, 2B, and 3 Groups | GLP-1RA versus DPP4i | 0.87 | 95% Confidence Interval 0.82 to 0.93 | Hazard Ratio |
| 3-point Major Adverse Cardiovascular Event (MACE) | Aims 1, 2B, and 3 Groups | SGLT2i versus DPP4i | 0.85 | 95% Confidence Interval 0.81 to 0.90 | Hazard Ratio |
| 3-point Major Adverse Cardiovascular Event (MACE) | Aims 1, 2B, and 3 Groups | SU versus DPP4i | 1.19 | 95% Confidence Interval 1.16 to 1.22 | Hazard Ratio |
| 3-point Major Adverse Cardiovascular Event (MACE) | Aims 1, 2B, and 3 Groups | SGLT2i versus GLP-1RA | 0.97 | 95% Confidence Interval 0.90 to 1.05 | Hazard Ratio |
| 3-point Major Adverse Cardiovascular Event (MACE) | Aims 1, 2B, and 3 Groups | SU versus GLP-1RA | 1.36 | 95% Confidence Interval 1.28 to 1.46 | Hazard Ratio |
| 3-point Major Adverse Cardiovascular Event (MACE) | Aims 1, 2B, and 3 Groups | SU versus SGLT2i | 1.40 | 95% Confidence Interval 1.33 to 1.47 | Hazard Ratio |
| Expanded Major Adverse Cardiovascular Events (MACE) and Its Components | Aims 1, 2B, and 3 Groups | GLP-1RA versus DPP4i | 0.95 | 95% Confidence Interval 0.91 to 1.00 | Hazard Ratio |
| Expanded Major Adverse Cardiovascular Events (MACE) and Its Components | Aims 1, 2B, and 3 Groups | SGLT2i versus DPP4i | 0.93 | 95% Confidence Interval 0.89 to 0.96 | Hazard Ratio |
| Expanded Major Adverse Cardiovascular Events (MACE) and Its Components | Aims 1, 2B, and 3 Groups | SU versus DPP4i | 1.14 | 95% Confidence Interval 1.12 to 1.17 | Hazard Ratio |
| Expanded Major Adverse Cardiovascular Events (MACE) and Its Components | Aims 1, 2B, and 3 Groups | SGLT2i versus GLP-1RA | 0.97 | 95% Confidence Interval 0.92 to 1.02 | Hazard Ratio |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aims 1, 2B, and 3 Groups | 386,276 | |
| Overall Study | STARTED | Aim 2A Group | 25 | |
| Overall Study | COMPLETED | Aims 1, 2B, and 3 Groups | 380,352 | |
| Overall Study | COMPLETED | Aim 2A Group | 25 | |
| Overall Study | NOT COMPLETED | Aims 1, 2B, and 3 Groups | 5,924 | |
| Overall Study | NOT COMPLETED | Aim 2A Group | 0 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Revascularization Procedure | Cardiac disorders | Aims 1, 2B, and 3 Groups | 42,514 | 386,276 | |
| other | Revascularization Procedure | Cardiac disorders | Aim 2A Group | 0 | 25 | |
| other | Lower Extremity Complication | Injury, poisoning and procedural complications | Aims 1, 2B, and 3 Groups | 21,466 | 386,276 | |
| other | Lower Extremity Complication | Injury, poisoning and procedural complications | Aim 2A Group | 0 | 25 | |
| other | Treatment for Retinopathy | Eye disorders | Aims 1, 2B, and 3 Groups | 4,934 | 386,276 | |
| other | Treatment for Retinopathy | Eye disorders | Aim 2A Group | 0 | 25 | |
| serious | Acute MI | Cardiac disorders | Aims 1, 2B, and 3 Groups | 11,372 | 386,276 | |
| serious | Acute MI | Cardiac disorders | Aim 2A Group | 0 | 25 | |
| serious | Acute Stroke | Nervous system disorders | Aims 1, 2B, and 3 Groups | 10,647 | 386,276 | |
| serious | Acute Stroke | Nervous system disorders | Aim 2A Group | 0 | 25 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aims 1, 2B, and 3 Groups | 22,208 | 386,276 |
| Total, all-cause mortality | Aim 2A Group | 0 | 25 |
| Total, other adverse events | Aims 1, 2B, and 3 Groups | 62,982 | 386,276 |
| Total, other adverse events | Aim 2A Group | 0 | 25 |
| Total, serious adverse events | Aims 1, 2B, and 3 Groups | 40,642 | 386,276 |
| Total, serious adverse events | Aim 2A Group | 0 | 25 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Aims 1, 2B, and 3 Groups vs Aim 2A Group: deaths from any cause | Trial comparisons |
| Aims 1, 2B, and 3 Groups vs Aim 2A Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05214573
GET https://conductscience.org/api/trials/v1/NCT05214573/results?page=2