The PEP-DM Trial

STUDY BASICS

Do you have recurrent acute pancreatitis or chronic pancreatitis with diabetes? You may be eligible for a drug trial testing two FDA approved diabetes medication to develop a personalized medicine approach for recurrent and chronic pancreatitis. Study participation involves up to 4 scheduled clinic visits and up to 6 scheduled phone or video visits over a 26-week period. Compensation provided.

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 recurrent acute pancreatitis or chronic pancreatitis with diabetes mellitus.

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.