Pancreatin Added to Standard Diabetes Therapy
Official title: The Effect of Pancreatin Added to Standard Antihyperglycemic Therapy on Metabolic Control in Patients With Type 2 Diabetes
Run by Silesian Centre for Heart Diseases · NCT07852988 · Data updated 2026-11-12
Researchers are testing whether adding pancreatin helps people with type 2 diabetes see better blood sugar control when they already take oral meds or insulin.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 35 Years to 75 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Silesian Centre for Heart Diseases Academic / other |
| Locations | 1 site (Zabrze, Silesian Voivodeship) |
| Status | Recruiting |
| Started | August 1, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | October 1, 2026 |
| Trial ID | NCT07852988 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 35–75 with type 2 diabetes for at least 12 months, on oral antihyperglycemic agents and/or insulin, and HbA1c 6.5–9.0%.
✕Probably not a fit
Patients with active pancreatic disease, prior pancreatin use recently, or those on incretin-based therapies are less likely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, double-blind, placebo-controlled phase 4 study will evaluate the effect of oral pancreatin on incretin hormones and glycemic control in adults with type 2 diabetes who are already on oral antihyperglycemic agents or insulin. Participants will be assigned to pancreatin 25,000 U with meals or placebo for 3 months, with 50 people in each group. The study aims to see if pancreatin increases GIP and GLP-1 levels and reduces postprandial glucose, potentially improving overall glycemic management without exocrine pancreatic insufficiency. Eligible participants are adults 35–75 with type 2 diabetes for at least 12 months and HbA1c 6.5–9.0%, excluding those on incretin-based therapies or with pancreatic disease.
Why it matters
Potential benefit: If successful, pancreatin could modestly improve postprandial glucose control in patients with type 2 diabetes who are already on standard therapies.
How similar studies have gone: Prior evidence in cystic fibrosis and chronic pancreatitis suggests pancreatin can boost incretin hormones and insulin, but this is a novel application in type 2 diabetes.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Department of Internal Medicine, Diabetology and Cardiometabolic Disorders, Faculty of Medical Sciences Zabrze
Zabrze, Silesian Voivodeship, Poland Recruiting
Study contacts
- Principal investigator: Marta Wróbel, PhD — Department of Internal Medicine, Diabetology and Cardiometabolic Disorders
- Study coordinator: Marta Wróbel, PhD
- Email: mwrobel@sum.edu.pl
- Phone: 48606873060
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.