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

ConditionsPancreatitis, Chronic Pancreatitis, Acute 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) 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.

Eligibility criteria

This trial does not accept healthy volunteers

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, or acute pancreatitis followed by diabetes (AP-DM) 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

Design model

Parallel

Treatments tested in this trial

Pioglitazone (PIO)
Drug
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.
Empagliflozin (EMPA)
Drug
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.

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: Pioglitazone (PIO)Experimental treatment 1 intervention

Group B: Empagliflozin (EMPA)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Other outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

University of Pittsburgh Medical Center

Collaborator

Source ClinicalTrials.gov

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