Multicentre, randomized, double blind, placebo-controlled study to evaluate the effect of pancreatic enzyme replacement therapy on glucose metabolism, nutritional parameters, incretin response and beta-cell function in patients with diabetes mellitus and exocrine pancreatic insufficiency

Multicentre, randomized, double blind, placebo-controlled study to evaluate the effect of pancreatic enzyme replacement therapy on glucose metabolism, nutritional parameters, incretin response and beta-cell function in patients with diabetes mellitus and exocrine pancreatic insufficiency - Pancreatic enzyme replacement therapy in diabetes mellitus and exocrine pancreatic insufficiency

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013022

Enrollment

120

Registered

2014-02-01

Start date

2014-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The licensing phase

Interventions

study drug/placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Patients with type 1 and type 2 diabetes mellitus with a fecal elastase test <100 microgram/gram will be recruited. -Patients between 18 and 70 years old -Signed informed consent

Exclusion criteria

Exclusion criteria: -Patients with any severe diseases -Any type of malignancy -Any history of gastrointestinal surgery, -Any known reason for maldigestion or malabsorption -Any history of alcohol or drug abuse -Proven gastroparesis or diarrhea -Females with existing or intended pregnancy or breast-feeding, or not using adequate birth control

Design outcomes

Primary

Measure	Time frame
Evaluation of pancreatic enzyme replacement therapy in patients with diabetes mellitus and exocrine pancreatic insufficiency able to improve glucose metabolism.	—

Secondary

Measure	Time frame
To study the effect of pancreatic enzyme replacement therapy in patients with diabetes mellitus and exocrine pancreatic insufficiency on 1) nutritional parameters; 2) incretin response; 3) beta-cell function; 4) blood glucose variability; 5) autonomic neuropathy.	—

Countries

Europe

Contacts

Public ContactGabor Zsori, MD

First Department of Internal Medicine Gastroenterology

zsori.gabor861@gmail.com36-62-545-186

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026