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RECRUITING Phase 4 ClinicalTrials.gov

Pancreatin Added to Standard Antihyperglycemic Therapy in Patients With Type 2 Diabetes

Sponsor: Silesian Centre for Heart Diseases • ClinicalTrials.gov ID: NCT07852988

Registry updated: 2026-10-01
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Description

Medications that enhance the incretin effect (GLP-1 receptor agonists, tirzepatide (GIP/GLP-1 receptor agonist) and DPP-4 inhibitors) are used in treatment of patients with type 2 diabetes. GLP-1 agonists and tirzepatide not only effectively lower blood glucose levels but also promote weight loss-primarily by stimulating the satiety center in the central nervous system - and reduce cardiovascular risk. Evidence suggests that oral pancreatin supplementation also enhances the incretin effect by increasing GIP and GLP-1 concentrations, and consequently insulin levels, which translates into a reduction in postprandial glycemia in patients with cystic fibrosis or chronic pancreatitis. In our study we aim to evaluate the impact of pancreatin on the incretin effect and glycemic control in patients with type 2 diabetes without exocrine pancreatic insufficiency.

Interventions

  • Pancreatin (Drug)
    Pancreatin 25 000 U with each of the 3 main meals daily for 3 months
  • Placebo (Drug)
    Placebo capsule with each of the 3 main meals daily for 3 months

Eligibility criteria

Inclusion Criteria: * Type 2 diabetes diagnosed for at least 12 months * Patients treated with oral antihyperglycemic agents and/or insulin as monotherapy or combination therapy * Age between 35 and 75 years * HbA1c: 6.5% - 9.0% Exclusion Criteria: * Type 1 diabetes * Use of incretin-based drugs (GLP-1 receptor agonists, dual GIP and GLP-1 receptor agonists, DPP-4 inhibitors) currently or within the last 3 months * History of pancreatic surgery * History of chronic pancreatitis * History of acute pancreatitis

Conditions

Type 2 Diabetes (T2DM)

Locations

  • Department of Internal Medicine, Diabetology and Cardiometabolic Disorders, Faculty of Medical Sciences Zabrze — Zabrze, Silesian Voivodeship, Poland
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record