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.
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%
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
Parallel
Pancreatin
DrugPancreatin 25 000 U with each of the 3 main meals daily for 3 months
Placebo
DrugPlacebo capsule with each of the 3 main meals daily for 3 months
Glycemic control
HbA1c value
Time in range
Time in range (glucose 70-180 mg/dl)
Body weight
Body weight measurement
Lipid profile
Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglicerides
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Silesian Centre for Heart Diseases
Lead sponsor
Medical University of Silesia
Collaborator
