RecruitingPhase 2NCT06729996

Pioglitazone Versus Empagliflozin for Chronic Pancreatitis/Recurrent Acute Pancreatitis Associated Diabetes Mellitus

Randomized, Parallel Group, Dose Escalation Trial of Pioglitazone Versus Empagliflozin for Chronic Pancreatitis/Recurrent Acute Pancreatitis Associated Diabetes Mellitus: The PEP-DM Trial

Sponsor

Mayo Clinic

Enrollment

40 participants

Start Date

May 29, 2025

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus Pancreatitis, Chronic Pancreatitis, Acute

Summary

The purpose of this study is to evaluate efficacy of pioglitazone (PIO) versus empagliflozin (EMPA) to improve glycemic control in people with Chronic Pancreatitis (CP) or Recurrent Acute Pancreatitis (RAP) associated with Diabetes Mellitus (DM). To evaluate mixed meal response in PIO versus EMPA group to better understand physiology of both therapies in CP-DM.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Empagliflozin (EMPA) and a drug called Pioglitazone (PIO) for people with diabetes mellitus, pancreatitis, acute, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPioglitazone (PIO)

Subjects will take 30 mg tablet, once daily in the morning, taken with or without food for 12 weeks and after 12 weeks dose will be escalated to 45 mg based on Hemoglobin A1c (HbA1c) levels (HbA1c \>7.0% at 12 weeks, escalate the dose) once daily in the morning, taken with or without food till 24 weeks.

DRUGEmpagliflozin (EMPA)

Subjects will start with 10 mg dose, once daily in the morning, taken with or without food for 12 weeks and after 12 weeks dose will be escalated to 25 mg based on Hemoglobin A1c (HbA1c) levels (HbA1c \>7.0% at 12 weeks, escalate the dose) once daily in the morning, taken with or without food.