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N/A N=494,679

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

Diabetes Mellitus, Type 2

Enrolled (actual)
494,679
Serious AEs
Results posted
Mar 2024
Primary outcome: Primary: Incidence Rate of Acute Pancreatitis — 10.30; 11.65 Events per 1,000 person-years

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
empagliflozin (Drug); Oral non-incretin/non-sodium glucose co-transporter-2 inhibitors (SGLT2)-containing hypoglycaemic agents (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Boehringer Ingelheim
Primary completion
Sep 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Incidence Rate of Acute Pancreatitis
10.30; 11.65

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.

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05162014). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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