Diabetes Mellitus, Type 2NCT05162014

To Assess the Risk of Acute Pancreatitis in Patients With Type 2 Diabetes Mellitus Treated With Empagliflozin

An observational study of Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To compare the risk of acute pancreatitis in patients with Type 2 diabetes mellitus (T2DM) newly initiating empagliflozin to that of patients newly initiating other oral non-incretin/non-Sodium glucose co-transporter-2 inhibitor (SGLT2i)-containing hypoglycemic agents. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: empagliflozin and Oral non-incretin/non-sodium glucose co-transporter-2 inhibitors (SGLT2)-containing hypoglycaemic agents
Type of treatment: Pill or oral medicine
How many people: 494,679 participants
Where: 1 siteGermany
Study dates: 20 Dec 2021to 12 Sep 2022
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: All patients with a recorded diagnosis of Type 2 diabetes mellitus (T2DM) who initiated empagliflozin or other oral non-incretin/non-Sodium glucose co-transporter-2 inhibitor (SGLT2i)-containing hypoglycaemic agents (metformin, Sulfonylurea (SU), or Thiazolidinediones (TZD)) between 1 August 2014 and 31 October 2020 will be selected.

Who may be able to join

Patients >= 18 years old
A diagnosis of Type 2 diabetes mellitus (T2DM) as demonstrated by at least one qualifying diagnosis code from any encounter type recorded in the claims in the 6 months prior to the drug initiation.
Patients initiating empagliflozin (as monotherapy, on a background of metformin, or on a background of metformin and Sulfonylurea (SU)) or qualifying comparator (metformin monotherapy, SU on a background of metformin, or Thiazolidinediones (TZD) on a background of metformin and SU) during the study period.
Have at least 6 months of continuous registration in the database prior to initiation of empagliflozin or a comparator drug.

Who cannot join

Patients with missing or ambiguous age or sex information.
Use of a Sodium glucose co-transporter-2 inhibitor (SGLT2i), Dipeptidyl peptidase 4 inhibitors (DPP-4i) or Glucagon-like peptide-1 receptor agonist (GLP-1 RA) in the 6 months prior to study drug initiation.
Chronic use of insulin in the outpatient setting in the 6 months prior to the study drug initiation. This criterion will help us to remove severe cases of diabetes and reduce the risk of residual confounding as diabetes is a risk factor for developing acute pancreatitis.
Patients with type 1 diabetes mellitus (T1DM) defined as at least 1 inpatient or outpatient International Classification of Diseases Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis code of 250.x1 or 250.x3 or International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis code of E10.x in the 6 months prior to the study drug initiation.
Patients with secondary diabetes or gestational diabetes in the 6 months prior to the study drug initiation.
Claims for acute or chronic pancreatitis, pancreatic cancer, or other disease of the pancreas any time prior to the study drug initiation.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Boehringer Ingelheim International GmbH
Ingelheim, 55216

Other trials in Germany

About this study

Official title: Post-authorization Safety Study (PASS) to Assess the Risk of Acute Pancreatitis in Type 2 Diabetes Mellitus (T2DM) Patients Newly Initiating Empagliflozin Compared to Other Oral Non-incretin/Non-sodium Glucose Co-transporter-2 Inhibitors (SGLT2)-Containing Glucose Lowering Drugs

Conditions: Diabetes Mellitus, Type 2
Being tested: empagliflozin, Oral non-incretin/non-sodium glucose co-transporter-2 inhibitors (SGLT2)-containing hypoglycaemic agents
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

empagliflozinDrug
empagliflozin
Oral non-incretin/non-sodium glucose co-transporter-2 inhibitors (SGLT2)-containing hypoglycaemic agentsDrug
Oral non-incretin/non-sodium glucose co-transporter-2 inhibitors (SGLT2)-containing hypoglycaemic agents

Study groups in NCT05162014
Study group	Role	What they receive
Pooled Empagliflozin		Patients with type 2 diabetes mellitus (T2DM) and new initiators of empagliflozin on a background of metformin, between 1-Aug-2014 and the latest data-cut available in IBM MarketScan Commercial Claims and Encounters (CCAE)/ Medicare Supplemental (MDCR) 30-Sep-2020 and Optum Clinformatics® Data Mart (CDM) 31-Mar-202, who were enrolled for a minimum of 6 months in the US claims databases before index treatment initiation Receives: Drug: empagliflozin
Pooled Sulfonylureas (SUs)		Patients with type 2 diabetes mellitus (T2DM) and new initiators of Sulfonylureas (SUs) on a background of metformin, between 1-Aug-2014 and the latest data-cut available in IBM MarketScan Commercial Claims and Encounters (CCAE)/ Medicare Supplemental (MDCR) 30-Sep-2020 and Optum Clinformatics® Data Mart (CDM) 31-Mar-202, who were enrolled for a minimum of 6 months in the US claims databases before index treatment initiation Receives: Drug: Oral non-incretin/non-sodium glucose co-transporter-2 inhibitors (SGLT2)-containing hypoglycaemic agents

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence Rate of Acute Pancreatitis
Incidence rate of acute pancreatitis per number of person-years, defined as an acute pancreatitis diagnosis from any of the inpatient (not restricted to the primary diagnosis), outpatient, or emergency contacts diagnoses (ICD-9-CM 577.0 or ICD-10-CM K85) and a lipase measure within +/- 7 days of the acute pancreatitis diagnosis (using LOINC code of 3040-3 and 2572-6 or CPT code of 83690 for lipase) and an abdominal ultrasound (using CPT codes of 76700 and 76705) within +/- 7 days of the acute pancreatitis diagnosis. The incidence rate was reported as the number of events (counts the first event per patient) divided by the total number of person-years at risk during follow-up (1/(1000*person-years)).
Measured: From August 2014 to March 2021 (the study period). Up to 79 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Dec 202112 Sep 2022

First posted17 Dec 2021
Study start20 Dec 2021
Primary completion12 Sep 2022
Study completion12 Sep 2022

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.
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: 494,679 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05162014
Sponsor's protocol ID: 1245-0201
Status last verified: Apr 2024
First submitted: 9 Dec 2021
Last updated: 2 May 2024
Results posted: Yes, on ClinicalTrials.gov
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-authorization Safety Study (PASS) to Assess the Risk of Acute Pancreatitis in Type 2 Diabetes Mellitus (T2DM) Patients Newly Initiating Empagliflozin Compared to Other Oral Non-incretin/Non-sodium Glucose Co-transporter-2 Inhibitors (SGLT2)-Containing Glucose Lowering Drugs
ClinicalTrials.gov ID: NCT05162014
Acronym / sponsor ID: 1245-0201
Conditions: Diabetes Mellitus, Type 2
Study type: Observational
Recruitment status: Completed
Enrolment: 494,679 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 20 Dec 2021 (actual)
Primary completion: 12 Sep 2022 (actual)
Study completion: 12 Sep 2022 (actual)
First posted: 17 Dec 2021 (actual)
Results: Posted 18 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Pooled Empagliflozin	–	Drug: empagliflozinPatients with type 2 diabetes mellitus (T2DM) and new initiators of empagliflozin on a background of metformin, between 1-Aug-2014 and the latest data-cut available in IBM MarketScan Commercial Claims and Encounters (CCAE)/ Medicare Supplemental (MDCR) 30-Sep-2020 and Optum Clinformatics® Data Mart (CDM) 31-Mar-202, who were enrolled for a minimum of 6 months in the US claims databases before index treatment initiation
Pooled Sulfonylureas (SUs)	–	Drug: Oral non-incretin/non-sodium glucose co-transporter-2 inhibitors (SGLT2)-containing hypoglycaemic agentsPatients with type 2 diabetes mellitus (T2DM) and new initiators of Sulfonylureas (SUs) on a background of metformin, between 1-Aug-2014 and the latest data-cut available in IBM MarketScan Commercial Claims and Encounters (CCAE)/ Medicare Supplemental (MDCR) 30-Sep-2020 and Optum Clinformatics® Data Mart (CDM) 31-Mar-202, who were enrolled for a minimum of 6 months in the US claims databases before index treatment initiation

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All patients with a recorded diagnosis of Type 2 diabetes mellitus (T2DM) who initiated empagliflozin or other oral non-incretin/non-Sodium glucose co-transporter-2 inhibitor (SGLT2i)-containing hypoglycaemic agents (metformin, Sulfonylurea (SU), or Thiazolidinediones (TZD)) between 1 August 2014 and 31 October 2020 will be selected.

Key inclusion criteria (4 listed)

Patients >= 18 years old
A diagnosis of Type 2 diabetes mellitus (T2DM) as demonstrated by at least one qualifying diagnosis code from any encounter type recorded in the claims in the 6 months prior to the drug initiation.
Patients initiating empagliflozin (as monotherapy, on a background of metformin, or on a background of metformin and Sulfonylurea (SU)) or qualifying comparator (metformin monotherapy, SU on a background of metformin, or Thiazolidinediones (TZD) on a background of metformin and SU) during the study period.
Have at least 6 months of continuous registration in the database prior to initiation of empagliflozin or a comparator drug.

Key exclusion criteria (6 listed)

Patients with missing or ambiguous age or sex information.
Use of a Sodium glucose co-transporter-2 inhibitor (SGLT2i), Dipeptidyl peptidase 4 inhibitors (DPP-4i) or Glucagon-like peptide-1 receptor agonist (GLP-1 RA) in the 6 months prior to study drug initiation.
Chronic use of insulin in the outpatient setting in the 6 months prior to the study drug initiation. This criterion will help us to remove severe cases of diabetes and reduce the risk of residual confounding as diabetes is a risk factor for developing acute pancreatitis.
Patients with type 1 diabetes mellitus (T1DM) defined as at least 1 inpatient or outpatient International Classification of Diseases Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis code of 250.x1 or 250.x3 or International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis code of E10.x in the 6 months prior to the study drug initiation.
Patients with secondary diabetes or gestational diabetes in the 6 months prior to the study drug initiation.

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	Pooled Empagliflozin
Oral non-incretin/non-sodium glucose co-transporter-2 inhibitors (SGLT2)-containing hypoglycaemic agentsOral non-incretin/non-sodium glucose co-transporter-2 inhibitors (SGLT2)-containing hypoglycaemic agents	Drug	Pooled Sulfonylureas (SUs)

Primary outcome

Incidence Rate of Acute Pancreatitis
Time frame: From August 2014 to March 2021 (the study period). Up to 79 months.
Incidence rate of acute pancreatitis per number of person-years, defined as an acute pancreatitis diagnosis from any of the inpatient (not restricted to the primary diagnosis), outpatient, or emergency contacts diagnoses (ICD-9-CM 577.0 or ICD-10-CM K85) and a lipase measure within +/- 7 days of the acute pancreatitis diagnosis (using LOINC code of 3040-3 and 2572-6 or CPT code of 83690 for lipase) and an abdominal ultrasound (using CPT codes of 76700 and 76705) within +/- 7 days of the acute pancreatitis diagnosis. The incidence rate was reported as the number of events (counts the first event per patient) divided by the total number of person-years at risk during follow-up (1/(1000*person-years)).

Results and safety

Results posted to the registry on 18 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pooled Empagliflozin	72,661	72,661
Pooled Sulfonylureas (SUs)	422,018	422,018

Primary outcome: Incidence Rate of Acute Pancreatitis

Time frame: From August 2014 to March 2021 (the study period). Up to 79 months.. Number (95% Confidence Interval). Unit: Events per 1,000 person-years

Measure	Pooled Empagliflozin - PS Matched n = 72621	Pooled Sulfonylureas (SUs) - PS Matched n = 72621
Value	10.30 (9.29 to 11.39)	11.65 (10.59 to 12.77)

Pooled Empagliflozin - PS Matched vs Pooled Sulfonylureas (SUs) - PS Matched: Hazard Ratio (HR): 0.88 (95% CI 0.76 to 1.02), Regression, Cox

Population analysed: Pooled unmatched and 1:1 propensity scores (PS) matched cohort of patients with type 2 diabetes mellitus (T2DM) and new initiators of empagliflozin or sulfonylureas (SUs), who were enrolled between 1 August 2014 and the latest data-cut available in IBM MarketScan CCAE/MDCR (30 September 2020) and Optum CDM (31 March 2021). Primary analysis represented an 'as treated' approach.

Adverse events

Time frame: Adverse event information was not applicable for this study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pooled Empagliflozin - PS Matched	0 of 0	0 of 0	0
Pooled Sulfonylureas (SUs) - PS Matched	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): This was a Non interventional study (NIS) based on existing data. Therefore, the study might be subject to potential residual confounding due to the absence of certain key data. In November 2021, an initial feasibility assessment was conducted which showed that the therapy cohort Empagliflozin vs. Sulfonylurea (SU) reported the highest number of empagliflozin initiators and was the only adequately powered line of therapy.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

Related trials for Diabetes Mellitus, Type 2

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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, run by Boehringer Ingelheim at 1 site in Germany.

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 4 inclusion and 6 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 2 May 2024. 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 Germany. 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 18 Mar 2024). 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?

Incidence Rate of Acute Pancreatitis (time frame: From August 2014 to March 2021 (the study period). Up to 79 months.). 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 NCT05162014.

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 2 May 2024.