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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

494679 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-20

Study Completion Date

2022-09-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

empagliflozin

Intervention Type 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

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

Intervention Type DRUG

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

Interventions

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empagliflozin

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No