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

NCT07852988 | Recruiting Phase 4

• 2 other identifiers: Pancreatin - type 2 diabetesBNW-1-089/N/5/K
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes (T2DM)

Keywords

type 2 diabetes; pancreatin; glycemic control; incretin effect

Outcome Measures

Primary Outcomes (2)

• Glycemic control

  HbA1c value

  3 months

• Time in range

  Time in range (glucose 70-180 mg/dl)

  3 months

Secondary Outcomes (2)

• Body weight

  3 months

• Lipid profile

  3 months

Study Arms (2)

Pancreatin

EXPERIMENTAL

Participants receiving pancreatin

Drug: Pancreatin

Control

PLACEBO COMPARATOR

Participants receiving placebo

Drug: Placebo

Interventions

Pancreatin DRUG

Pancreatin 25 000 U with each of the 3 main meals daily for 3 months

Also known as: ActiveLab

Pancreatin

Placebo DRUG

Placebo capsule with each of the 3 main meals daily for 3 months

Also known as: ActivLab Placebo

Control

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Silesian Centre for Heart Diseases: lead
• Medical University of Silesia: collaborator

Study Sites (1)

Department of Internal Medicine, Diabetology and Cardiometabolic Disorders, Faculty of Medical Sciences Zabrze

Zabrze, Silesian Voivodeship, 41-800, Poland

RECRUITING

Related Publications (3)

• Perano SJ, Couper JJ, Horowitz M, Martin AJ, Kritas S, Sullivan T, Rayner CK. Pancreatic enzyme supplementation improves the incretin hormone response and attenuates postprandial glycemia in adolescents with cystic fibrosis: a randomized crossover trial. J Clin Endocrinol Metab. 2014 Jul;99(7):2486-93. doi: 10.1210/jc.2013-4417. Epub 2014 Mar 26.

  PMID: 24670086 BACKGROUND

• Knop FK, Vilsboll T, Larsen S, Hojberg PV, Volund A, Madsbad S, Holst JJ, Krarup T. Increased postprandial responses of GLP-1 and GIP in patients with chronic pancreatitis and steatorrhea following pancreatic enzyme substitution. Am J Physiol Endocrinol Metab. 2007 Jan;292(1):E324-30. doi: 10.1152/ajpendo.00059.2006. Epub 2006 Sep 5.

  PMID: 16954337 BACKGROUND

• Ebert R, Creutzfeldt W. Reversal of impaired GIP and insulin secretion in patients with pancreatogenic steatorrhea following enzyme substitution. Diabetologia. 1980 Sep;19(3):198-204. doi: 10.1007/BF00275269.

  PMID: 6997121 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Pancreatin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Hydrolases; Enzymes; Enzymes and Coenzymes; Pancreatic Extracts; Tissue Extracts; Complex Mixtures

Study Officials

• Marta Wróbel, PhD

  Department of Internal Medicine, Diabetology and Cardiometabolic Disorders

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta Wróbel, PhD

CONTACT

48606873060; mwrobel@sum.edu.pl

Paulina Piekarz-Ząbek, MD

CONTACT

‭+48 604 223 652‬; k_bielawa@poczta.fm

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: October 1, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: after publication, till 5 yrs
• Access Criteria: via email:mwrobel@sum.edu.pl

Locations

PL (1)