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

September 23, 2026 updated by: Silesian Centre for Heart Diseases

The Effect of Pancreatin Added to Standard Antihyperglycemic Therapy on Metabolic Control in Patients With Type 2 Diabetes

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) are the two primary incretin hormones secreted from the small intestine on ingestion of glucose or nutrients to stimulate insulin secretion from pancreatic β cells. They play a role in regulation of blood glucose levels, particularly postprandial glycemia. Lipids and carbohydrates are the most potent stimulators of incretin hormone secretion. Pancreatin is a mixture of digestive enzymes naturally produced by the pancreas, which is used as a medication supporting macronutrient digestion, especially in cases of exocrine pancreatic insufficiency. Evidence suggests that oral pancreatin supplementation 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. Based on a randomized, placebo-controlled, double-blind study, we aim to evaluate the effect of pancreatin on the incretin effect and glycemic control in patients with type 2 diabetes without exocrine pancreatic insufficiency.

We plan to recruit a total of 100 patients with type 2 diabetes treated with oral antihyperglycemic drugs or insulin, either as monotherapy or in combination. Patients will be randomly divided into 2 groups:

  • Group of 50 patients receiving pancreatin 25 000 U with up to 3 main meals daily for 3 months
  • Group of 50 patients receiving placebo with up to 3 main meals daily for 3 months

Baseline assessment:

  • Anthropometric parameters: body weight, height, waist-to-hip ratio, body composition (bioelectrical impedance analysis)
  • Laboratory tests: aspartate aminotransferase, alanine aminotransferase, serum amylase, lipid profile, HbA1c, selected cytokines, average glucose concentration from the last 7 days before study start (glucometer - 4 measurements per day), data from the FreeStyle Libre2 continuous glucose monitoring system (2 weeks prior to study start): assessment of TIR (Time in Range 70-180 mg/dL), glycemic variability coefficient (CV), standard deviation (SD), mean glucose concentration, frequency and severity of hypoglycemia; daily insulin requirements from the last 7 days (for insulin-treated patients)

Assessment after study completion:

  • Anthropometric parameters: body weight, height, waist-to-hip ratio, body composition (bioelectrical impedance analysis)
  • Laboratory tests: aspartate aminotransferase, alanine aminotransferase, serum amylase, lipid profile, HbA1c, selected cytokines, average glucose concentration from the last 7 days before study end (glucometer - 4 measurements per day), data from the FreeStyle Libre 2 continuous glucose monitoring system (last 2 weeks of study): assessment of TIR, CV, SD, mean glucose concentration, frequency and severity of hypoglycemia; daily insulin requirements from the last 7 days (for insulin-treated patients).

Should pancreatin demonstrate a beneficial effect on glycemic homeostasis, these formulations could serve as a valuable adjunctive therapy for type 2 diabetes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Paulina Piekarz-Ząbek, MD
  • Phone Number: ‭+48 604 223 652‬
  • Email: k_bielawa@poczta.fm

Study Locations

  • Poland
    • Silesian Voivodeship
      • Zabrze, Silesian Voivodeship, Poland, 41-800
        • Recruiting
        • Department of Internal Medicine, Diabetology and Cardiometabolic Disorders, Faculty of Medical Sciences Zabrze
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pancreatin

Participants receiving pancreatin
Drug: Pancreatin

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

Other Names:
  • ActiveLab
Placebo Comparator: Control

Participants receiving placebo
Drug: Placebo

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

Other Names:
  • ActivLab Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Glycemic control
Time Frame: 3 months

HbA1c value
3 months
Time in range
Time Frame: 3 months

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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body weight
Time Frame: 3 months

Body weight measurement
3 months
Lipid profile
Time Frame: 3 months

Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglicerides
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Silesian Centre for Heart Diseases

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medical University of Silesia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marta Wróbel, PhD, Department of Internal Medicine, Diabetology and Cardiometabolic Disorders

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pancreatin - type 2 diabetes
  • BNW-1-089/N/5/K (Other Grant/Funding Number: Medical University of Silesia, Katowice, Poland)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual participant data and the study protocol will be made available upon reasonable request.

IPD Sharing Time Frame

after publication, till 5 yrs

IPD Sharing Access Criteria

via email:mwrobel@sum.edu.pl

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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