Actively Recruiting
Randomized Dose Escalation Trial of Pioglitazone Versus Empagliflozin for Chronic and Recurrent Acute Pancreatitis Associated Diabetes Mellitus
Led by Mayo Clinic · Updated on 2026-04-03
40
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
U
University of Pittsburgh Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of pioglitazone (PIO) compared to empagliflozin (EMPA) in improving blood sugar control in adults aged 18 to 80 years with chronic pancreatitis (CP) or recurrent acute pancreatitis (RAP) associated with diabetes mellitus (DM). This phase 2 study aims to better understand how these two medications affect the body's response to meals and glucose regulation in people with CP-DM. Participants will be randomly assigned to receive either pioglitazone or empagliflozin. Those in the pioglitazone group will start with 30 mg tablets once daily in the morning for 12 weeks, with a possible increase to 45 mg after 12 weeks based on blood sugar levels. Those in the empagliflozin group will begin with 10 mg tablets once daily in the morning for 12 weeks, with a potential increase to 25 mg after 12 weeks if needed. Both medications are taken with or without food. The treatment period lasts 24 weeks in total. During the study, participants will undergo various assessments including measurements of hemoglobin A1c, glucose, insulin, C-peptide, and glucagon levels from baseline to 24 weeks. Additional evaluations will include body composition, blood pressure, cholesterol levels, inflammatory markers, and patient-reported outcomes. Participants will also perform blood glucose and ketone testing using study-provided meters. Safety and treatment effects will be monitored throughout the trial, which is expected to run until May 2027.
CONDITIONS
Brief Title
Pioglitazone Versus Empagliflozin for Chronic Pancreatitis/Recurrent Acute Pancreatitis Associated Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years at enrollment
- Diagnosis of recurrent acute pancreatitis or chronic pancreatitis with diabetes mellitus
- Able to provide written informed consent and participate in long-term follow-up
- Stable retinal exam within 1 year before enrollment or scheduled eye exam during study if recent exam unavailable
- Hemoglobin A1c between 6.5% and 10.5% at screening
- Current treatment with metformin, insulin, or other antihyperglycemic medications allowed if willing to adjust under supervision; patients not on these medications also eligible
- Stable dose of GLP-1 medication for at least 3 months before enrollment with stable weight and no dose increase during study
- Willing to perform blood glucose and ketone testing using study-provided meters
You will not qualify if you...
- Allergy or hypersensitivity to pioglitazone or empagliflozin or drug interactions
- Currently taking pioglitazone or empagliflozin
- Diagnosis of type 1 diabetes
- Pregnant or breastfeeding women (positive pregnancy test at screening)
- History of bleeding disorders such as hemophilia or platelet disorders
- Liver impairment with ALT greater than 3 times normal or acute/chronic liver disease
- Active cancer treatment excluding some skin cancers
- Untreated osteoporosis
- Recent inflammatory illness within 30 days before enrollment
- Heart failure NYHA Class III or higher
- Kidney dysfunction with eGFR below 30 mL/min/1.73m2
- Participation in another clinical trial within 30 days before screening
- Active alcohol, chemical, or tobacco dependence
- Following a ketogenic diet
- Autoimmune or obstructive pancreatitis or prior pancreas surgery
- Any condition risking participant safety as judged by investigator
- Recent diabetic ketoacidosis or unstable diabetes within 6 months or elevated beta-hydroxybutyrate at screening above 0.4 mmol/L
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants take either Pioglitazone or Empagliflozin daily to improve glycemic control. Dosage may be escalated at 12 weeks based on blood sugar levels.
Visits approximately at baseline, 12 weeks, and 24 weeks
Trial Site Locations
Total: 2 locations
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
2
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15219
Not Yet Recruiting
Research Team
R
Ravinder Jeet Kaur, M.B.B.S
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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