Who is eligible for clinical trial NCT06729996?

Participants must meet the protocol's inclusion criteria for Pancreatitis, Chronic. The stated age range is 18 Years to 80 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT06729996 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-07-27

Pioglitazone Versus Empagliflozin for Chronic Pancreatitis/Recurrent Acute Pancreatitis/Acute Pancreatitis Associated Diabetes Mellitus (NCT06729996)

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

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Mayo Clinic

🩺 Plain-English Summary (8th-Grade Level)

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) or Acute Pancreatitis (AP) 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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (18 items).

Location: Mayo Clinic — Rochester, Minnesota

Age range: 18 Years to 80 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Age ≥18-80 years at the time of enrollment.
RAP or CP with DM diagnosed before or after CP diagnosis (Confirmed CP on imaging or RAP based on PROCEED study criteria, or acute pancreatitis followed by diabetes (AP-DM) and confirmed DM as per ADA criteria or clinically diagnosed with DM and on antihyperglycemic therapy)
Able to provide written informed consent and participate in longitudinal follow-up
A Stable retinal exam within 1 year prior to enrollment unless new onset diabetes was diagnosed within 6 months prior to study enrollment. If an eye exam within the past year is not available but the most recent exam is stable, a standard of care eye exam needs to be scheduled during the study period.
HbA1c level 6.5-10.5% at screening visit.
Current ongoing treatment with metformin and/or insulin and other antihyperglycemic medications will be accepted at screening. Patients will be willing to safely withdraw one or more study medication or mealtime insulin under the supervision of the study team by the time of screening. The patients clinical team will be informed promptly. Patients not on any antihyperglycemic medications are also eligible. a. If on a GLP-1 medication (e.g., semaglutide \[Ozempic, Wegovy, Rybelsus\], liraglutide, dulaglutide, exenatide, tirzepatide, etc.), the patient must be on a stable dose for at least 3 months prior to enrollment, with stable weight status at the time of enrollment and the GLP-1 dose cannot be escalated during the study period.
Willing to perform blood glucose and ketone testing on study provided meters as per study protocol.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Inability to take PIO or EMPA due to prior hypersensitivity or allergic reaction or current use of medications with potential for drug-drug interactions (Pioglitazone: Drug information - UpToDate, Empagliflozin: Drug information - UpToDate)
Patients on PIO or EMPA at the time of screening
Diagnosed with Type 1 Diabetes
Pregnancy or lactation in women (positive urine pregnancy test at screening will lead to exclusion)
History of bleeding disorders (e.g., Hemophilia A (factor VIII deficiency), hemophilia B (factor IX deficiency), von Willebrand disease, platelet disorders etc)
Presence of hepatic impairment, ALT \>3 x ULN with no etiology known at the time of enrollment or any evidence of acute/chronic liver disease
Ongoing treatment for any malignancy requiring systemic treatment (non-melanoma skin cancers treated in dermatologists' office would be acceptable)
Presence of osteoporosis without definitive treatment according to PI discretion.
Recent inflammatory illness within the 30 days preceding enrollment (e.g.: URTI, episode of AP, etc)
History of heart failure classified by NYHA as Class III or greater
History of kidney dysfunction classified by an eGFR of \<30 mL/min/min

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (3 Sites)

Mayo Clinic — Rochester, Minnesota
University of Pittsburgh — Pittsburgh, Pennsylvania
University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania

📞 Contact the Study Coordinator

Phone: (507) 255-1455

Email: Kaur.ravinder@mayo.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗