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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05162014
• Other study ID #: 1245-0201
• Status: Completed
• Start date: December 20, 2021
• Est. completion date: September 12, 2022

Study information

• Verified date: April 2024
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 494679
• Est. completion date: September 12, 2022
• Est. primary completion date: September 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Pancreatitis

Intervention

Drug:
• empagliflozin
empagliflozin
• Oral non-incretin/non-sodium glucose co-transporter-2 inhibitors (SGLT2)-containing hypoglycaemic agents
Oral non-incretin/non-sodium glucose co-transporter-2 inhibitors (SGLT2)-containing hypoglycaemic agents

Locations

Country	Name	City	State
Germany	Boehringer Ingelheim International GmbH	Ingelheim am Rhein

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)).	From August 2014 to March 2021 (the study period). Up to 79 months.

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