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SGLT2 Inhibitor

Pioglitazone vs Empagliflozin for Diabetes (PEP-DM Trial)

Phase 2

Recruiting

Led By Yogish Kudva

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18-70 years at the time of enrollment

Not on any antihyperglycemic medication except Metformin

Must not have

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

History of kidney dysfunction classified by eGFR of <30 mL/min/min

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to compare two medications, pioglitazone and empagliflozin, to see which one is better at improving blood sugar control in people with Chronic Pancreatitis or

Who is the study for?

This trial is for individuals with diabetes that's related to chronic or recurrent acute pancreatitis. Participants should have a history of these conditions and need better blood sugar control.

What is being tested?

The study aims to compare the effectiveness of two diabetes medications, Pioglitazone (PIO) and Empagliflozin (EMPA), in managing blood sugar levels in patients with pancreatitis-associated diabetes.

What are the potential side effects?

Pioglitazone may cause weight gain, swelling, and bone fractures. Empagliflozin can lead to urinary tract infections, dehydration, low blood pressure, and ketoacidosis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

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I am only taking Metformin for my blood sugar.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have osteoporosis as shown by my medical records.

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My kidney function is very low.

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I have had pancreatitis or surgery on my pancreas.

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I cannot take PIO or EMPA due to allergies or current medications I'm on.

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I have a history of bleeding disorders like Hemophilia or von Willebrand disease.

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My liver isn't working properly, and doctors don't know why.

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I have been diagnosed with Type 1 Diabetes.

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I haven't had severe diabetes issues or high ketone levels in the past 6 months.

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I have severe heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

AUC for C-peptide

AUC for Insulin

AUC for glucagon

+2 more

Secondary study objectives

Beta cell function

Blood Pressure

Body Mass Index (BMI)

+11 more

Other study objectives

Acute pancreatitis episodes

Adverse events

Bone fractures

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Pioglitazone (PIO)Experimental Treatment1 Intervention

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.

Group II: Empagliflozin (EMPA)Experimental Treatment1 Intervention

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.

0 / 11Eligibility criteria met