The effect of pancreatic enzyme replacement therapy on glucose metabolism and nutritional parameters in patients with diabetes mellitus

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005491-20-HU

Enrollment

Registered

2016-03-21

Start date

2016-08-29

Completion date

Unknown

Last updated

2025-02-24

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

Conditions

To study the patients with diabetes mellitus (type 1, 2 and 3c) and exocrine pancreatic insufficiency.

Interventions

Trade Name: Panzytrat 25000 Product Name: Panzytrat 25000 Product Code: OGYI/7537/2015 OGYI/7544/2015 Pharmaceutical Form: Capsule, hard Pharmaceutical form of the placebo: Capsule, hard Route of admi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with type 1 and type 2 diabetes mellitus with a fecal elastase test =65 years) yes F.1.3.1 Number of subjects for this age range 10

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
Main Objective: To study the effect of pancreatic enzyme replacement therapy in patients with diabetes mellitus and exocrine pancreatic insufficiency on glucose metabolism, nutritional parameters, incretin response and beta-cell function.;Secondary Objective: 1. To prospectively study the prevalence of T3cDM. 2. To prospectively study the frequency of exocrine insufficiency in T1 and T2DM.;Primary end point(s): To study the effect of pancreatic enzyme replacement therapy in patients with diabetes mellitus and exocrine pancreatic insufficiency on glucose metabolism, nutritional parameters, incretin response and beta-cell function.;Timepoint(s) of evaluation of this end point: Before the start of the study drug and 4 and 8 weeks and 3 and 6 months afterwards.	—

Measure

Time frame

Main Objective: To study the effect of pancreatic enzyme replacement therapy in patients with diabetes mellitus and exocrine pancreatic insufficiency on glucose metabolism, nutritional parameters, incretin response and beta-cell function.;Secondary Objective: 1. To prospectively study the prevalence of T3cDM. 2. To prospectively study the frequency of exocrine insufficiency in T1 and T2DM.;Primary end point(s): To study the effect of pancreatic enzyme replacement therapy in patients with diabetes mellitus and exocrine pancreatic insufficiency on glucose metabolism, nutritional parameters, incretin response and beta-cell function.;Timepoint(s) of evaluation of this end point: Before the start of the study drug and 4 and 8 weeks and 3 and 6 months afterwards.

—

Secondary

Measure	Time frame
Secondary end point(s): 1. To prospectively study the prevalence of T3cDM. 2. To prospectively study the frequency of exocrine insufficiency in T1 and T2DM.;Timepoint(s) of evaluation of this end point: The end of the study	—

Countries

Hungary

Contacts

Public ContactActavis Hungary

Actavis Hungary Gyógyszermarketing és Kereskedelmi Korlátolt Felelosségu Társaság

daniel.kosa@actavis.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026