The PEP-DM Trial

STUDY BASICS

Have you ever had pancreatitis? Do you also have diabetes? If you have recurrent acute pancreatitis, chronic pancreatitis or developed diabetes after an episode of acute pancreatitis, you may be eligible for a drug trial testing two FDA approved diabetes medication. Study participation involves up to 4 clinic visits and up to 6 phone or video visits over a 26-week period.

STUDY PURPOSE

The purpose of this research study is to develop a personalized medicine approach for patients with recurrent acute pancreatitis or chronic pancreatitis with diabetes mellitus.

COULD THIS STUDY BE RIGHT FOR YOU?

• Ages 18-80 years old
• Have diabetes mellitus type 2 or type 3c
• Have recurrent acute pancreatitis OR chronic pancreatitis OR developed diabetes after an episode of acute pancreatitis.

WHAT PARTICIPANTS CAN EXPECT

Study participation involves up to 4 scheduled clinic visits and up to 6 scheduled phone or video visits over a 26-week period. There are two phases to the study described below.

1. At the screening visit, the study team will provide you with a continuous glucose monitor (CGM) that you will wear for 10 days. We will call this the run-in phase.
2. After the run-in phase, you will return to be randomized to one of two FDA-approved medication groups, Empagliflozin (EMPA) or Pioglitazone (PIO). These medications will be provided by the study. This phase will last about 6 months. Each group will follow the same visit format described later in this form.