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Recruiting Phase 2 NCT06729996

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

Trial Parameters

Condition Pancreatitis, Chronic
Sponsor Mayo Clinic
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 40
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2025-05-29
Completion 2027-05-31
Interventions
Pioglitazone (PIO)Empagliflozin (EMPA)

Brief Summary

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

Inclusion 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. Exclusion Criteria: * 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

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