EUCTR2015-005491-20-HUActive, not recruitingPhase 1
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
Actavis Hungary Gyógyszermarketing és Kereskedelmi Korlátolt Felelosségu Társaság0 sitesStarted: March 21, 2016Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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