Diabetes Mellitus, Type 2NCT03492580
A Study for Comparison of Canagliflozin Versus Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Participants With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease
An observational study of Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The primary purpose of study is to estimate the incidence and comparative effect on health outcomes: 1) hospitalization for heart failure, 2) below knee lower extremity amputation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
- What is being tested?
- Canagliflozin, Empagliflozin and Dapagliflozin
- How many people
- 714,582 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2018to 25 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants diagnosed with type 2 diabetes mellitus (T2DM) and established cardiovascular (CV) disease over a 4-year period 1 April 2013 and 15 May 2017 will be observed.
Who may be able to join
- First exposure to the particular drug(s) in database (index date)
- Exposure start is between 1 April 2013 and 15 May 2017
- At least 365 days of continuous observation time prior to index
- At least 1 condition occurrence of 'Type II diabetes' any time in the prior continuous observation time (which is at least 365 days long) before or on the index date (first exposure to the particular drug(s) in database)
- For cohort with 'established cardiovascular disease - At least 1 occurrence of 'conditions indicating established cardiovascular disease' on or any time in the prior continuous observation time (which is at least 365 days long) prior to the index date
Who cannot join
- Participants with type 1 diabetes or secondary diabetes prior to or on the index date of exposure were excluded from the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Janssen Investigative Site
Titusville, New Jersey, 08560
About this study
Official title: Comparison of Canagliflozin vs. Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Patients With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease
The primary purpose of study is to estimate the incidence and comparative effect on health outcomes: 1) hospitalization for heart failure, 2) below knee lower extremity amputation. The date of first exposure to the particular drug(s) in the database, where the exposure start is between 1-April-2013 to 15-May-2017 and outcome data for these participants will be analyzed and reported in this study.
- Conditions
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
- Being tested
- Canagliflozin, Empagliflozin, Dapagliflozin, Dipeptidyl Peptidase-4 (DPP-4) Inhibitors, Glucagon-like Peptide-1 (GLP-1) Agonist
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CanagliflozinDrug
No intervention or treatment assignment imposed by this study. Participants received canagliflozin as a part of routine clinical practice.
EmpagliflozinDrug
No intervention or treatment assignment imposed by this study. Participants received empagliflozin as a part of routine clinical practice.
DapagliflozinDrug
No intervention or treatment assignment imposed by this study. Participants received dapagliflozin as a part of routine clinical practice.
Dipeptidyl Peptidase-4 (DPP-4) InhibitorsDrug
No intervention or treatment assignment imposed by this study. Participants received DPP-4 inhibitor as a part of routine clinical practice. DPP-4 inhibitors includes: alogliptin, linagliptin, saxagliptin, sitagliptin, vildagliptin.
Glucagon-like Peptide-1 (GLP-1) AgonistDrug
No intervention or treatment assignment imposed by this study. Participants received GLP-1 agonist as a part of routine clinical practice. GLP-1 agonists includes: albiglutide, dulaglutide, exenatide, liraglutide, lixisenatide.
Anti-hyperglycemic Agents (AHA)Drug
No intervention or treatment assignment imposed by this study. Participants received other selected AHA as a part of routine clinical practice. Other select AHAs includes: acarbose, bromocriptine, miglitol, nateglinide, repaglinide.
Thiazolidinediones (TZD)Drug
No intervention or treatment assignment imposed by this study. Participants received TZD as a part of routine clinical practice. TZDs includes: pioglitazone, rosiglitazone, troglitazone.
Sulfonylureas (SU)Drug
No intervention or treatment assignment imposed by this study. Participants received SU as a part of routine clinical practice. SUs includes: glipizide, glyburide, glimepiride, chlorpropamide, tolazamide, tolbutamide, acetohexamide
InsulinDrug
No intervention or treatment assignment imposed by this study. Participants received Insulin as a part of routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Canagliflozin | A target cohort which includes new users of canagliflozin for clinical characterization, and population-level effect estimation. It will use 4 databases: 1. Truven Health MarketScan Commercial Claims and Encounters Database (CCAE) 2. Truven Health MarketScan Medicare Supplemental and Coordination of Benefits Database (MDCR) 3. Truven Health MarketScan Multi-state Medicaid Database (MDCD) 4. OptumInsight's de-identified Clinformatics Datamart, Extended-Date of Death (Optum). Receives: Drug: Canagliflozin | |
| Cohort 2: Canagliflozin with Cardiovascular Disease (CVD) | A target cohort which includes new users of canagliflozin with established CVD for clinical characterization and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum. Receives: Drug: Canagliflozin | |
| Cohort 3: Empagliflozin | A comparator cohort which includes new users of empagliflozin for clinical characterization, and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum. Receives: Drug: Empagliflozin | |
| Cohort 4: Empagliflozin with CVD | A comparator cohort which includes new users of empagliflozin with established CVD for clinical characterization and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum. Receives: Drug: Empagliflozin | |
| Cohort 5: Dapagliflozin | A comparator cohort which includes new users of dapagliflozin for clinical characterization, and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum. Receives: Drug: Dapagliflozin | |
| Cohort 6: Dapagliflozin with CVD | A comparator cohort which includes new users of dapagliflozin with established CVD for clinical characterization and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum. Receives: Drug: Dapagliflozin | |
| Cohort 7: Empagliflozin or Dapagliflozin | A target cohort which includes new users of empagliflozin or dapagliflozin for clinical characterization, and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum. Receives: Drug: Empagliflozin; Drug: Dapagliflozin | |
| Cohort 8: Empagliflozin or Dapagliflozin with CVD | A target cohort which includes new users of empagliflozin or dapagliflozin with established CVD for clinical characterization, and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum. Receives: Drug: Empagliflozin; Drug: Dapagliflozin | |
| Cohort 9: DPP-4 inhibitor (i)/ GLP-1 agonist (a)/ other AHA | A comparator cohort which includes new users of any dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) agonist, or other select antihyperglycemic agents (AHA) for clinical characterization, and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum. Receives: Drug: Dipeptidyl Peptidase-4 (DPP-4) Inhibitors; Drug: Glucagon-like Peptide-1 (GLP-1) Agonist; Drug: Anti-hyperglycemic Agents (AHA) | |
| Cohort 10: DPP-4 (i)/ GLP-1 (a)/ other AHA with CVD | A comparator cohort which includes new users of any DPP-4 inhibitor, GLP-1 agonist, or other select AHA with established CVD for clinical characterization, and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum. Receives: Drug: Dipeptidyl Peptidase-4 (DPP-4) Inhibitors; Drug: Glucagon-like Peptide-1 (GLP-1) Agonist; Drug: Anti-hyperglycemic Agents (AHA) | |
| Cohort 11: DPP-4 (i),GLP-1 (a),TZD, SU, insulin, other AHA | A comparator cohort which includes new users of any DPP-4 inhibitor, GLP-1 agonist, thiazolidinediones (TZD), sulfonylureas (SU), insulin, or other select AHA for clinical characterization, and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum. Receives: Drug: Dipeptidyl Peptidase-4 (DPP-4) Inhibitors; Drug: Glucagon-like Peptide-1 (GLP-1) Agonist; Drug: Anti-hyperglycemic Agents (AHA); Drug: Thiazolidinediones (TZD); Drug: Sulfonylureas (SU); Drug: Insulin | |
| Cohort 12: DPP-4(i), GLP-1(a), TZD, SU, insulin, AHA with CVD | A comparator cohort which includes new users of any DPP-4 inhibitor, GLP-1 agonist, TZD, SU, insulin, or other select AHA with established CVD for clinical characterization, and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum. Receives: Drug: Dipeptidyl Peptidase-4 (DPP-4) Inhibitors; Drug: Glucagon-like Peptide-1 (GLP-1) Agonist; Drug: Anti-hyperglycemic Agents (AHA); Drug: Thiazolidinediones (TZD); Drug: Sulfonylureas (SU); Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Hospitalizations for Heart Failure
Number of hospital admissions with a primary diagnosis of 'heart failure' will be reported.
Measured: Approximately 4-years
Number of Participants with Below Knee Lower Extremity Amputation Events
Number of participants with new below-knee lower extremity amputation procedures, excluding recent (within 30 day) revisions will be reported.
Measured: Approximately 4-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start22 Feb 2018
- Primary completion6 Apr 2018
- Study completion25 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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
- 714,582 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492580
- Sponsor's protocol ID
- CR108464
- Other IDs
- RRA-20250
- Status last verified
- Jun 2025
- First submitted
- 3 Apr 2018
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Canagliflozin vs. Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Patients With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT03492580
- Acronym / sponsor ID
- CR108464
- Conditions
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 714,582 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- 6 Apr 2018 (actual)
- Study completion
- 25 Jun 2018 (actual)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of study is to estimate the incidence and comparative effect on health outcomes: 1) hospitalization for heart failure, 2) below knee lower extremity amputation. The date of first exposure to the particular drug(s) in the database, where the exposure start is between 1-April-2013 to 15-May-2017 and outcome data for these participants will be analyzed and reported in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Canagliflozin | – | Drug: CanagliflozinA target cohort which includes new users of canagliflozin for clinical characterization, and population-level effect estimation. It will use 4 databases: 1. Truven Health MarketScan Commercial Claims and Encounters Database (CCAE) 2. Truven Health MarketScan Medicare Supplemental and Coordination of Benefits Database (MDCR) 3. Truven Health MarketScan Multi-state Medicaid Database (MDCD) 4. OptumInsight's de-identified Clinformatics Datamart, Extended-Date of Death (Optum). |
| Cohort 2: Canagliflozin with Cardiovascular Disease (CVD) | – | Drug: CanagliflozinA target cohort which includes new users of canagliflozin with established CVD for clinical characterization and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum. |
| Cohort 3: Empagliflozin | – | Drug: EmpagliflozinA comparator cohort which includes new users of empagliflozin for clinical characterization, and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum. |
| Cohort 4: Empagliflozin with CVD | – | Drug: EmpagliflozinA comparator cohort which includes new users of empagliflozin with established CVD for clinical characterization and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum. |
| Cohort 5: Dapagliflozin | – | Drug: DapagliflozinA comparator cohort which includes new users of dapagliflozin for clinical characterization, and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum. |
| Cohort 6: Dapagliflozin with CVD | – | Drug: DapagliflozinA comparator cohort which includes new users of dapagliflozin with established CVD for clinical characterization and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum. |
| Cohort 7: Empagliflozin or Dapagliflozin | – | Drug: Empagliflozin, Drug: DapagliflozinA target cohort which includes new users of empagliflozin or dapagliflozin for clinical characterization, and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum. |
| Cohort 8: Empagliflozin or Dapagliflozin with CVD | – | Drug: Empagliflozin, Drug: DapagliflozinA target cohort which includes new users of empagliflozin or dapagliflozin with established CVD for clinical characterization, and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum. |
| Cohort 9: DPP-4 inhibitor (i)/ GLP-1 agonist (a)/ other AHA | – | Drug: Dipeptidyl Peptidase-4 (DPP-4) Inhibitors, Drug: Glucagon-like Peptide-1 (GLP-1) Agonist, Drug: Anti-hyperglycemic Agents (AHA)A comparator cohort which includes new users of any dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) agonist, or other select antihyperglycemic agents (AHA) for clinical characterization, and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum. |
| Cohort 10: DPP-4 (i)/ GLP-1 (a)/ other AHA with CVD | – | Drug: Dipeptidyl Peptidase-4 (DPP-4) Inhibitors, Drug: Glucagon-like Peptide-1 (GLP-1) Agonist, Drug: Anti-hyperglycemic Agents (AHA)A comparator cohort which includes new users of any DPP-4 inhibitor, GLP-1 agonist, or other select AHA with established CVD for clinical characterization, and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum. |
| Cohort 11: DPP-4 (i),GLP-1 (a),TZD, SU, insulin, other AHA | – | Drug: Dipeptidyl Peptidase-4 (DPP-4) Inhibitors, Drug: Glucagon-like Peptide-1 (GLP-1) Agonist, Drug: Anti-hyperglycemic Agents (AHA), Drug: Thiazolidinediones (TZD), Drug: Sulfonylureas (SU), Drug: InsulinA comparator cohort which includes new users of any DPP-4 inhibitor, GLP-1 agonist, thiazolidinediones (TZD), sulfonylureas (SU), insulin, or other select AHA for clinical characterization, and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum. |
| Cohort 12: DPP-4(i), GLP-1(a), TZD, SU, insulin, AHA with CVD | – | Drug: Dipeptidyl Peptidase-4 (DPP-4) Inhibitors, Drug: Glucagon-like Peptide-1 (GLP-1) Agonist, Drug: Anti-hyperglycemic Agents (AHA), Drug: Thiazolidinediones (TZD), Drug: Sulfonylureas (SU), Drug: InsulinA comparator cohort which includes new users of any DPP-4 inhibitor, GLP-1 agonist, TZD, SU, insulin, or other select AHA with established CVD for clinical characterization, and population-level effect estimation. It will use 4 databases: 1. CCAE 2. MDCR 3. MDCD 4. Optum. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants diagnosed with type 2 diabetes mellitus (T2DM) and established cardiovascular (CV) disease over a 4-year period 1 April 2013 and 15 May 2017 will be observed.
Key inclusion criteria (5 listed)
- First exposure to the particular drug(s) in database (index date)
- Exposure start is between 1 April 2013 and 15 May 2017
- At least 365 days of continuous observation time prior to index
- At least 1 condition occurrence of 'Type II diabetes' any time in the prior continuous observation time (which is at least 365 days long) before or on the index date (first exposure to the particular drug(s) in database)
- For cohort with 'established cardiovascular disease - At least 1 occurrence of 'conditions indicating established cardiovascular disease' on or any time in the prior continuous observation time (which is at least 365 days long) prior to the index date
Key exclusion criteria (1 listed)
- Participants with type 1 diabetes or secondary diabetes prior to or on the index date of exposure were excluded from the study
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 |
|---|---|---|
| CanagliflozinNo intervention or treatment assignment imposed by this study. Participants received canagliflozin as a part of routine clinical practice. | Drug | Cohort 1: Canagliflozin, Cohort 2: Canagliflozin with Cardiovascular Disease (CVD) |
| EmpagliflozinNo intervention or treatment assignment imposed by this study. Participants received empagliflozin as a part of routine clinical practice. | Drug | Cohort 3: Empagliflozin, Cohort 4: Empagliflozin with CVD, Cohort 7: Empagliflozin or Dapagliflozin, Cohort 8: Empagliflozin or Dapagliflozin with CVD |
| DapagliflozinNo intervention or treatment assignment imposed by this study. Participants received dapagliflozin as a part of routine clinical practice. | Drug | Cohort 5: Dapagliflozin, Cohort 6: Dapagliflozin with CVD, Cohort 7: Empagliflozin or Dapagliflozin, Cohort 8: Empagliflozin or Dapagliflozin with CVD |
| Dipeptidyl Peptidase-4 (DPP-4) InhibitorsNo intervention or treatment assignment imposed by this study. Participants received DPP-4 inhibitor as a part of routine clinical practice. DPP-4 inhibitors includes: alogliptin, linagliptin, saxagliptin, sitagliptin, vildagliptin. | Drug | Cohort 10: DPP-4 (i)/ GLP-1 (a)/ other AHA with CVD, Cohort 11: DPP-4 (i),GLP-1 (a),TZD, SU, insulin, other AHA, Cohort 12: DPP-4(i), GLP-1(a), TZD, SU, insulin, AHA with CVD, Cohort 9: DPP-4 inhibitor (i)/ GLP-1 agonist (a)/ other AHA |
| Glucagon-like Peptide-1 (GLP-1) AgonistNo intervention or treatment assignment imposed by this study. Participants received GLP-1 agonist as a part of routine clinical practice. GLP-1 agonists includes: albiglutide, dulaglutide, exenatide, liraglutide, lixisenatide. | Drug | Cohort 10: DPP-4 (i)/ GLP-1 (a)/ other AHA with CVD, Cohort 11: DPP-4 (i),GLP-1 (a),TZD, SU, insulin, other AHA, Cohort 12: DPP-4(i), GLP-1(a), TZD, SU, insulin, AHA with CVD, Cohort 9: DPP-4 inhibitor (i)/ GLP-1 agonist (a)/ other AHA |
| Anti-hyperglycemic Agents (AHA)No intervention or treatment assignment imposed by this study. Participants received other selected AHA as a part of routine clinical practice. Other select AHAs includes: acarbose, bromocriptine, miglitol, nateglinide, repaglinide. | Drug | Cohort 10: DPP-4 (i)/ GLP-1 (a)/ other AHA with CVD, Cohort 11: DPP-4 (i),GLP-1 (a),TZD, SU, insulin, other AHA, Cohort 12: DPP-4(i), GLP-1(a), TZD, SU, insulin, AHA with CVD, Cohort 9: DPP-4 inhibitor (i)/ GLP-1 agonist (a)/ other AHA |
| Thiazolidinediones (TZD)No intervention or treatment assignment imposed by this study. Participants received TZD as a part of routine clinical practice. TZDs includes: pioglitazone, rosiglitazone, troglitazone. | Drug | Cohort 11: DPP-4 (i),GLP-1 (a),TZD, SU, insulin, other AHA, Cohort 12: DPP-4(i), GLP-1(a), TZD, SU, insulin, AHA with CVD |
| Sulfonylureas (SU)No intervention or treatment assignment imposed by this study. Participants received SU as a part of routine clinical practice. SUs includes: glipizide, glyburide, glimepiride, chlorpropamide, tolazamide, tolbutamide, acetohexamide | Drug | Cohort 11: DPP-4 (i),GLP-1 (a),TZD, SU, insulin, other AHA, Cohort 12: DPP-4(i), GLP-1(a), TZD, SU, insulin, AHA with CVD |
| InsulinNo intervention or treatment assignment imposed by this study. Participants received Insulin as a part of routine clinical practice. | Drug | Cohort 11: DPP-4 (i),GLP-1 (a),TZD, SU, insulin, other AHA, Cohort 12: DPP-4(i), GLP-1(a), TZD, SU, insulin, AHA with CVD |
Primary outcome
Number of Hospitalizations for Heart Failure
Time frame: Approximately 4-years
Number of hospital admissions with a primary diagnosis of 'heart failure' will be reported.
Number of Participants with Below Knee Lower Extremity Amputation Events
Time frame: Approximately 4-years
Number of participants with new below-knee lower extremity amputation procedures, excluding recent (within 30 day) revisions will be reported.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
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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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
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 Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Janssen Research & Development, LLC 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 5 inclusion and 1 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 25 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Hospitalizations for Heart Failure (time frame: Approximately 4-years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2025.