Randomized, Parallel Group, Dose Escalation Trial of Pioglitazone Versus Empagliflozin for Chronic Pancreatitis/Recurrent Acute Pancreatitis Associated Diabetes Mellitus: The PEP-DM Trial
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Age ≥18-70 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, 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
• Stable last annual retinal exam within 1 year prior to enrollment.
• HbA1c level 7-10% at screening visit.
• Fasting plasma glucose \<220 mg/dL at screening visit.
• Not on any antihyperglycemic medication except Metformin
• Willing to perform blood glucose and ketone testing on study provided meters as per study protocol.
Locations
United States
Minnesota
Mayo Clinic
RECRUITING
Rochester
Pennsylvania
University of Pittsburgh Medical Center
NOT_YET_RECRUITING
Pittsburgh
Contact Information
Primary
Corey Kurek, BS
Reid.Corey@mayo.edu
507-255-0316
Time Frame
Start Date:2025-05-29
Estimated Completion Date:2027-05-31
Participants
Target number of participants:40
Treatments
Experimental: Pioglitazone (PIO)
PIO (Actos) is a thiazolidinedione and an agonist for peroxisome proliferator activated receptor (PPAR) gamma indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 DM in multiple clinical settings. Its use has limitation for type 1 DM or for treatment of diabetic ketoacidosis. It is contraindicated to use in established NYHA class III or IV heart failure.
Experimental: Empagliflozin (EMPA)
EMPA is a sodium-glucose co-transporter 2 inhibitor, FDA approved drug. It is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure, to reduce the risk of cardiovascular death in adults with type 2 DM and established cardiovascular disease and as an adjunct to diet and exercise to improve glycemic control in adults with type 2 DM. It is not recommended in patients with type 1 DM. It may increase the risk of diabetic ketoacidosis. Not recommended for use to improve glycemic control in adults with type 2 DM with an eGFR less than 30mL/min/1.73m2.