A Phase 2 interventional study of Pioglitazone (PIO) and Empagliflozin (EMPA) in Pancreatitis, Chronic, Pancreatitis, Acute and Diabetes Mellitus, sponsored by Mayo Clinic. Recruiting at 3 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Mayo Clinic · Phase 2, Interventional, and Treatment
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Among 111 studies in Pancreatitis, Chronic with a site in United States — 29 open to participants now, 39 under way, none of them phase 3. Pancreatitis, Chronic · United States.
Among the 111 studies in Pancreatitis, Chronic with a site in United States, this one is the 24th largest by planned enrollment of the 73 interventional ones that give a count, is one of 6 that started in 2025, is one of 7 in phase 2, reaches primary completion later than 14 of the 38 other live ones, and was the 99th registered.
264 studies on the registry are indexed under Pancreatitis, Chronic; 76 are open to participants now.
Browse Pancreatitis, Chronic studies →29 of the 111 studies in Pancreatitis, Chronic with a site in United States are open now. Recruiting first, the newest first:
Mayo Clinic · Sites in United States
Ages 18+
Orlando Health, Inc. · Sites in United States
Ages 18+
Anna Evans Phillips · Sites in United States
Ages 18+
Ohio State University · Sites in United States
Ages 18–80
Johns Hopkins University · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 49 Pancreatitis, Chronic studies recruiting now, 31 (63%) set no upper age limit and 12 (24%) stop at 75 or younger; 8 take children under 18; 11 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
111 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 21 · Phase 2 15 · Phase 3 7 · Phase 4 6
First in 2000; this study’s year is marked. 6 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 50 is above the median of 45 across 143 interventional studies indexed under Pancreatitis, Chronic.
Median enrollment 32 across the 73 interventional studies, 167 across the 38 observational. Of the 63 that completed or were terminated, 23 (37%) have results posted.
This tab as a report to print or save as PDF → With an account.
17 of 111 have an industry lead sponsor. The 10 most frequent:
Mayo Clinic is the lead sponsor of 3,271 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Mayo Clinic has 9 studies filed under Pancreatitis, Chronic — fewer than ten, so there is no comparison to draw.
16 of the studies in Pancreatitis, Chronic with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03097185Baylor Research InstituteAnalysis of Graft Function Following Autologous Islet Transplantation | 2026-12 |
| NCT07174609Johns Hopkins UniversityScrambler Therapy in Chronic Pancreatitis | 2026-12-01 |
| NCT05925036VA Office of Research and DevelopmentNovel Cellular Therapy for the Treatment of Pain Associated With Chronic Pancreatitis | 2026-12-31 |
| NCT06651580M.D. Anderson Cancer CenterBiospecimen Collection to Identify Gene Mutations for High Risk Pancreatic Cancer in Pediatric Patients, INSPPIRE 2 Study | 2027-02-02 |
| NCT07285863Mayo ClinicA Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects | 2027-03 |
Add all 16 to your calendar (.ics) → With an account.
Among the 111 studies in Pancreatitis, Chronic with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
This trial will test the efficacy of PIO versus EMPA in improving glycemic control in CP-DM, RAP-DM and DM after one episode AP. The anticipated enrollment will consist of 40 subjects, age 18-80 years who have been diagnosed with CP or RAP or AP with DM, at two clinical sites in the United States. The primary objective is to evaluate the efficacy of PIO vs. EMPA to improve glycemic control in people with CP or RAP or AP associated with DM.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Pioglitazone (PIO)
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.
Drug: Empagliflozin (EMPA)
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.
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.
Hemoglobin A1c (HbA1c)
Hemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An HbA1C level below 5.7 percent is considered normal. Reported as percentage of glycated hemoglobin
Time frame: Baseline to 24 weeks
Area under curve (AUC) for glucose
Pre-post study difference in AUC for glucose
Time frame: Baseline to 24 weeks
AUC for C-peptide
Pre-post study difference in AUC for C-Peptide
Time frame: Baseline to 24 weeks
AUC for Insulin
Pre-post study difference in AUC for Insulin
Time frame: Baseline to 24 weeks
AUC for glucagon
Pre-post study difference in AUC for glucagon
Time frame: Baseline to 24 weeks
Fasting plasma glucose
Pre-post study difference in Fasting plasma glucose
Time frame: Baseline to 24 weeks
Lean mass
Pre-post study difference in lean mass
Time frame: Baseline to 24 weeks
Fat mass
Pre-post study difference in fat mass
Time frame: Baseline to 24 weeks
Visceral fat
Pre-post study difference in visceral fat
Time frame: Baseline to 24 weeks
Fecal elastase
Pre-post study difference in Fecal elastase (ELISA quantitative test, normal \>200 mcg/g)
Time frame: Baseline to 24 weeks
High Sensitivity C-Reactive Protein (Hs-CRP)
Pre-post study difference in Hs-CRP
Time frame: Baseline to 24 weeks
Total cholesterol, LDL, HDL and Triglyceride
Pre-post study difference in Total cholesterol, LDL, HDL and Triglyceride
Time frame: Baseline to 24 weeks
β-Hydroxybutyrate
Pre-post study difference in β-Hydroxybutyrate
Time frame: Baseline to 24 weeks
Body weight
Pre-post study difference in body weight
Time frame: Baseline to 24 weeks
Blood Pressure
Pre-post study difference in Blood Pressure
Time frame: Baseline to 24 weeks
Body Mass Index (BMI)
Pre-post study difference in BMI
Time frame: Baseline to 24 weeks
Patient-Reported Outcomes Measurement Information System - 29 Profile v2.1 (PROMIS-29 Profile v2.1)
The PROMIS-29 Profile assesses following domains: * Physical function * Pain interference * Anxiety * Depression * Fatigue * Sleep disturbance * Ability to participate in social roles and activities PROMIS-29 is scored using T-scores. Higher T-scores indicate a higher level of the underlying construct. Each domain has a set of questions, typically 4 to 6 items, and responses are rated on a 5-point Likert scale (e.g., "Never," "Rarely," "Sometimes," "Often," "Always" or "Not at all," "A little bit," "Somewhat," etc.). The responses are then scored on a T-score scale (with a mean of 50 and a standard deviation of 10 in the general population). T-scores Interpretation: * A T-score of 50 is the average score for the general population. * T-scores above 50 indicate better functioning or less severe symptoms. * T-scores below 50 indicate worse functioning or more severe symptoms.
Time frame: Baseline to 24 weeks
Insulin sensitivity
Change in sensitivity from baseline vs 24 weeks (Homeostatic Model Assessment, Matsuda Index)
Time frame: Baseline to 24 weeks
Beta cell function
Change in Beta cell function from baseline vs 24 weeks using oral disposition index
Time frame: Baseline to 24 weeks
Ketosis
Percentage of participants experiencing Ketosis based on meter data
Time frame: Baseline to 24 weeks
Diabetic Ketoacidosis (DKA) events
Number of DKA events
Time frame: Baseline to 24 weeks
Insulin needs
Percentage of participants experiencing requirement for insulin
Time frame: Baseline to 24 weeks
Chronic pancreatitis exacerbation
Percentage of participants experiencing CP exacerbation
Time frame: Baseline to 24 weeks
Acute pancreatitis episodes
Percentage of participants experiencing AP episodes
Time frame: Baseline to 24 weeks
Exocrine pancreatic insufficiency
Percentage of participants experiencing incident exocrine pancreatic insufficiency
Time frame: Baseline to 24 weeks
Vitamin D
Decrease in vitamin D
Time frame: Baseline to 24 weeks
Bone fractures
Percentage of participants experiencing bone fractures
Time frame: Baseline to 24 weeks
Adverse events
Adverse events: Anemia, edema, urinary tract infection, Vaginal yeast infection
Time frame: Baseline to 24 weeks
Plan to share: No
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for May 2027, 24 months after the start.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Pioglitazone · Empagliflozin