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Type 2 Diabetes (T2DM)Phase 4NCT07852988

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

A Phase 4 study testing Pancreatin in people with Type 2 Diabetes (T2DM), run by Silesian Centre for Heart Diseases at 1 site in Poland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 75 years
Conditions the study is for
Type 2 Diabetes (T2DM)
What is being tested?
Pancreatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 sitePoland
Study dates
1 Aug 2026to 31 Dec 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marta Wróbel, PhD contact

48606873060

mwrobel@sum.edu.pl

Paulina Piekarz-Ząbek, MD contact

‭+48 604 223 652‬

k_bielawa@poczta.fm

Poland1 site, 1 recruiting

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

    Zabrze, Silesian Voivodeship, 41-800

    Marta Wróbel, PhD, +48606873060, mwrobel@sum.edu.pl

    Paulina Piekarz-Ząbek, MD, ‭+48 604 223 652‬, k_bielawa@poczta.fm

    Recruiting

Other trials in Poland

About this study

Official title: 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.

Read the 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.

Being tested
Pancreatin, Placebo
Keywords
type 2 diabetes, pancreatin, glycemic control, incretin effect
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PancreatinDrug

    Also called ActiveLab

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

  • PlaceboDrug

    Also called ActivLab Placebo

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

Study groups in NCT07852988
Study groupRoleWhat they receive
PancreatinExperimentalParticipants receiving pancreatin
Receives: Drug: Pancreatin
ControlPlacebo comparatorParticipants receiving placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycemic control

    HbA1c value

    Measured: 3 months

  2. Time in range

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

    Measured: 3 months

Secondary outcomes (2)

  1. Body weight

    Body weight measurement

    Measured: 3 months

  2. Lipid profile

    Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglicerides

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2026
  2. Study start1 Aug 2026
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07852988
Sponsor's protocol ID
Pancreatin - type 2 diabetes
Other IDs
BNW-1-089/N/5/K
Status last verified
Sep 2026
First submitted
23 Sep 2026
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified individual participant data and the study protocol will be made available upon reasonable request.

Publications

  • 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.

    PubMed 24670086

  • 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.

    PubMed 16954337

  • 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.

    PubMed 6997121

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pancreatin in people with Type 2 Diabetes (T2DM), run by Silesian Centre for Heart Diseases at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marta Wróbel, PhD (48606873060, mwrobel@sum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycemic control (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07852988, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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