RECRUITING

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

Conditions

Pancreatitis, Chronic Pancreatitis, Acute Diabetes Mellitus pancreatitis diabetes empagliflozin pioglitazone

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-12-16

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06729996

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* 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) * 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 (the threshold of bone density value below the -2.5 SDS of T-score or presence of one or more fragility fractures), on electronic medical record. * Recent inflammatory illness within the 30 days preceding enrollment (e.g.: URTI, episode of AP, etc) * History of heart failure classified by New York Heart Association as Class III or greater * History of kidney dysfunction classified by eGFR of \<30 mL/min/min * Participation in any clinical trial within 30 days before screening for an approved or non-approved investigational medical product. * Active alcohol dependence or chemical dependence including tobacco based on investigator discretion * On a ketogenic diet * Autoimmune pancreatitis, obstructive pancreatitis, and prior surgery of pancreas * Any condition which could jeopardize participant safety as per investigator opinion, (hemolytic anemia limiting HbA1c reliability, any evidence of fluid overload, presence of Congestive heart failure etc). * Recent DKA or signs of decompensated diabetes in last 6 months or increased β hydroxybutyrate levels (\>0.4 mmol/L) at screening.

Inclusion Criteria

Exclusion Criteria

* 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.

* 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)
* 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 (the threshold of bone density value below the -2.5 SDS of T-score or presence of one or more fragility fractures), on electronic medical record.
* Recent inflammatory illness within the 30 days preceding enrollment (e.g.: URTI, episode of AP, etc)
* History of heart failure classified by New York Heart Association as Class III or greater
* History of kidney dysfunction classified by eGFR of \<30 mL/min/min
* Participation in any clinical trial within 30 days before screening for an approved or non-approved investigational medical product.
* Active alcohol dependence or chemical dependence including tobacco based on investigator discretion
* On a ketogenic diet
* Autoimmune pancreatitis, obstructive pancreatitis, and prior surgery of pancreas
* Any condition which could jeopardize participant safety as per investigator opinion, (hemolytic anemia limiting HbA1c reliability, any evidence of fluid overload, presence of Congestive heart failure etc).
* Recent DKA or signs of decompensated diabetes in last 6 months or increased β hydroxybutyrate levels (\>0.4 mmol/L) at screening.

Contacts and Locations

Study Contact

Corey Kurek, BS

CONTACT

507-255-0316

Reid.Corey@mayo.edu

Principal Investigator

Yogish Kudva

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic

Rochester, Minnesota, 55905

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15219

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Yogish Kudva, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-16

Study Completion Date2026-12

Study Record Updates

Study Start Date2024-12-16

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

pancreatitis
diabetes
diabetes mellitus
empagliflozin
pioglitazone

Additional Relevant MeSH Terms

Pancreatitis, Chronic
Pancreatitis, Acute
Diabetes Mellitus