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

Phase 1

• Conditions: To study the patients with diabetes mellitus (type 1, 2 and 3c) and exocrine pancreatic insufficiency.; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-005491-20-HU
• Lead Sponsor: Actavis Hungary Gyógyszermarketing és Kereskedelmi Korlátolt Felelosségu Társaság

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-21
• Last Update Posted: 5 September 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients with type 1 and type 2 diabetes mellitus with a fecal elastase test <200 µg/g, between 18 and 80 years old and with signed inform consent will be recruited.
Patients are randomized to receive either pancreatin (Panzytrat 25.000 Ph.Eur.E.) or placebo in a double-blind manner. Study medication is taken three times a day with the main meals (2
capsules of 25.000 Ph.Eur.E. pancreatin or placebo). Additionally, two or three snacks accompanied by intake of one capsule of 25.000 Ph.Eur.E. of pancreatin or placebo is allowed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): 1. To prospectively study the prevalence of T3cDM. <br>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