Actively Recruiting
Pioglitazone Versus Empagliflozin for Chronic Pancreatitis/Recurrent Acute Pancreatitis Associated Diabetes Mellitus
Led by Mayo Clinic · Updated on 2026-04-03
40
Participants Needed
2
Research Sites
104 weeks
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
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.
CONDITIONS
Official Title
Pioglitazone Versus Empagliflozin for Chronic Pancreatitis/Recurrent Acute Pancreatitis Associated Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-80 years at enrollment
- Diagnosed with recurrent acute pancreatitis or chronic pancreatitis with diabetes mellitus
- Able to provide written informed consent and participate in follow-up
- Stable retinal eye exam within 1 year prior to enrollment or scheduled during study if not available
- Hemoglobin A1c level between 6.5% and 10.5% at screening
- Currently treated or not treated with metformin, insulin, or other antihyperglycemic medications, willing to adjust under supervision
- If on GLP-1 medication, must be on stable dose for at least 3 months before enrollment with stable weight and no dose increase during study
- Willing to perform blood glucose and ketone testing as per study protocol
You will not qualify if you...
- Allergy or intolerance to pioglitazone or empagliflozin or use of interacting medications
- Currently taking pioglitazone or empagliflozin at screening
- Diagnosis of type 1 diabetes
- Pregnancy or lactation
- History of bleeding disorders such as hemophilia or platelet disorders
- Liver impairment with ALT >3 times upper limit of normal or any acute/chronic liver disease
- Currently treated for malignancy requiring systemic treatment (except non-melanoma skin cancers treated in dermatologist office)
- Untreated osteoporosis
- Recent inflammatory illness within 30 days before enrollment
- Heart failure classified as New York Heart Association (NYHA) class III or greater
- Kidney dysfunction with estimated glomerular filtration rate (eGFR) below 30 mL/min
- Participation in any clinical trial within 30 days before screening
- Active alcohol, chemical, or tobacco dependence
- Following a ketogenic diet
- Autoimmune pancreatitis, obstructive pancreatitis, or prior pancreatic surgery
- Any condition posing safety risk as per investigator opinion
- Recent diabetic ketoacidosis or signs of decompensated diabetes in last 6 months or elevated beta hydroxybutyrate levels at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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