Diabetes Mellitus, Type 2NCT05102071
Clinical Outcomes and Healthcare Cost and Resource Utilization (HCRU) in Patients With Type 2 Diabetes and Cardiovascular Disease on 2nd Line Empagliflozin Versus 2nd Line Sulfonylureas
An observational study of Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Boehringer Ingelheim at 1 site in United States.
Trial summary
Evaluation of clinical outcomes (specifically cardiovascular outcomes like hospitalization for heart failure), and healthcare cost, and resource utilization, among patients on empagliflozin as an add-on therapy to metformin versus patients on sulfonylureas as an add-on therapy to metformin in patients with Type 2… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
- What is being tested?
- empagliflozin, metformin and sulfonylurea
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 15 Jun 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Type 2 Diabetes (T2D) and Cardiovascular Disease (CVD).
Who may be able to join
- Prevalent metformin use + initiation of empagliflozin OR prevalent metformin use + initiation of sulfonylurea
- ≥18 years of age at index date during study observation
- ≥1 inpatient and/or ≥ 2 outpatient claims denoting T2D diagnosis (in any position) in the 12 months prior to index date
- ≥1 inpatient and/or ≥2 outpatient claims denoting CVD (in any position) diagnosis in the 12 months prior to index date
- ≥2 months post-index date
- ≥12 months of no exposure to T2D medications in the pre-index period (excluding metformin in both arms)
- ≥12 months of continuous enrolment prior to index date
Who cannot join
- Diagnosis of Type 1 Diabetes, secondary, or gestational diabetes in the 12 months prior to index date
- Diagnosis of severe comorbidities including malignancy, end-stage renal disease, human immunodeficiency virus, Hepatitis C infection, or organ transplant in the 12 months prior to index date
- Admission to nursing home in the 12 months prior to index date
Trial locations and contacts
1 site in 1 country.
United States1 site
Boehringer Ingelheim Pharmaceuticals Inc
Ridgefield, Connecticut, 06879
About this study
Official title: Clinical and Economic Impact of 2nd Line Initiation of Empagliflozin After Metformin, as Compared to 2nd Line Initiation of Sulfonylurea After Metformin in Patients With Type 2 Diabetes and Cardiovascular Disease
Evaluation of clinical outcomes (specifically cardiovascular outcomes like hospitalization for heart failure), and healthcare cost, and resource utilization, among patients on empagliflozin as an add-on therapy to metformin versus patients on sulfonylureas as an add-on therapy to metformin in patients with Type 2 Diabetes (T2D) and Cardiovascular Disease (CVD).
- Conditions
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
- Being tested
- empagliflozin, metformin, sulfonylurea
- 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.
empagliflozinDrug
empagliflozin
metforminDrug
metformin
sulfonylureaDrug
sulfonylurea
| Study group | Role | What they receive |
|---|---|---|
| Treatment with empagliflozin | as add-on therapy with metformin Receives: Drug: empagliflozin; Drug: metformin | |
| Treatment with a sulfonylurea | as add-on therapy with metformin Receives: Drug: metformin; Drug: sulfonylurea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of first hospitalization for congestive heart failure (HHF)
Measured: up to 5 years and 3 months
Secondary outcomes (6)
Hospitalizations
Measured: up to 5 years and 3 months
Emergency department (ED) visits
Measured: up to 5 years and 3 months
Length of stay
Measured: up to 5 years and 3 months
Number of filled drugs
Measured: up to 5 years and 3 months
Outpatient visits
Measured: up to 5 years and 3 months
All cause cost
total cost of care, divided by medical (inpatient costs, outpatient costs, emergency costs) and pharmacy costs (all reported in Per Patient Per Month (PPPM) costs)
Measured: up to 5 years and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start1 Nov 2021
- Primary completion15 Jun 2022 (estimated)
- Study completion15 Jun 2022 (estimated)
Why it stopped: Study was canceled because database sample size was inadequate.
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 Boehringer IngelheimThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102071
- Sponsor's protocol ID
- 1245-0262
- Status last verified
- May 2022
- First submitted
- 28 Oct 2021
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Economic Impact of 2nd Line Initiation of Empagliflozin After Metformin, as Compared to 2nd Line Initiation of Sulfonylurea After Metformin in Patients With Type 2 Diabetes and Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT05102071
- Acronym / sponsor ID
- 1245-0262
- Conditions
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study was canceled because database sample size was inadequate.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 15 Jun 2022 (estimated)
- Study completion
- 15 Jun 2022 (estimated)
- First posted
- 1 Nov 2021 (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.
Evaluation of clinical outcomes (specifically cardiovascular outcomes like hospitalization for heart failure), and healthcare cost, and resource utilization, among patients on empagliflozin as an add-on therapy to metformin versus patients on sulfonylureas as an add-on therapy to metformin in patients with Type 2 Diabetes (T2D) and Cardiovascular Disease (CVD).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with empagliflozin | – | Drug: empagliflozin, Drug: metforminas add-on therapy with metformin |
| Treatment with a sulfonylurea | – | Drug: metformin, Drug: sulfonylureaas add-on therapy with metformin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Type 2 Diabetes (T2D) and Cardiovascular Disease (CVD).
Key inclusion criteria (7 listed)
- Prevalent metformin use + initiation of empagliflozin OR prevalent metformin use + initiation of sulfonylurea
- ≥18 years of age at index date during study observation
- ≥1 inpatient and/or ≥ 2 outpatient claims denoting T2D diagnosis (in any position) in the 12 months prior to index date
- ≥1 inpatient and/or ≥2 outpatient claims denoting CVD (in any position) diagnosis in the 12 months prior to index date
- ≥2 months post-index date
Key exclusion criteria (3 listed)
- Diagnosis of Type 1 Diabetes, secondary, or gestational diabetes in the 12 months prior to index date
- Diagnosis of severe comorbidities including malignancy, end-stage renal disease, human immunodeficiency virus, Hepatitis C infection, or organ transplant in the 12 months prior to index date
- Admission to nursing home in the 12 months prior to index date
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 |
|---|---|---|
| empagliflozinempagliflozin | Drug | Treatment with empagliflozin |
| metforminmetformin | Drug | Treatment with a sulfonylurea, Treatment with empagliflozin |
| sulfonylureasulfonylurea | Drug | Treatment with a sulfonylurea |
Primary outcome
Occurrence of first hospitalization for congestive heart failure (HHF)
Time frame: up to 5 years and 3 months
6 secondary outcomes
Hospitalizations
Time frame: up to 5 years and 3 months
Emergency department (ED) visits
Time frame: up to 5 years and 3 months
Length of stay
Time frame: up to 5 years and 3 months
Number of filled drugs
Time frame: up to 5 years and 3 months
Outpatient visits
Time frame: up to 5 years and 3 months
All cause cost
Time frame: up to 5 years and 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Boehringer Ingelheim 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 7 inclusion and 3 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: withdrawn, as of the sponsor's last update on 1 Jun 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
Occurrence of first hospitalization for congestive heart failure (HHF) (time frame: up to 5 years and 3 months). 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 1 Jun 2022; AzTrials last refreshed its copy on 8 Nov 2026.