Pioglitazone Versus Empagliflozin for Chronic Pancreatitis/Recurrent Acute Pancreatitis Associated Diabetes Mellitus
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMayo Clinic
About this trial
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 criteria
Qualifiers
Age ≥18-80 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
A Stable retinal exam within 1 year prior to enrollment unless new onset diabetes was diagnosed within 6 months prior to study enrollment. If an eye exam within the past year is not available but the most recent exam is stable, a standard of care eye exam needs to be scheduled during the study period.
Disqualifiers
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)
Patients on PIO or EMPA at the time of screening
Diagnosed with Type 1 Diabetes
Pregnancy or lactation in women (positive urine pregnancy test at screening will lead to exclusion)
Trial design
Treatments tested in this trial
- Pioglitazone (PIO)
- Empagliflozin (EMPA)
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Mayo Clinic
Lead sponsor
University of Pittsburgh Medical Center
Collaborator
Source ClinicalTrials.gov