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
Phase 4
- Conditions
- The licensing phase
- Registration Number
- JPRN-UMIN000013022
- Lead Sponsor
- First Department of Internal Medicine, Szeged
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Not provided
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,observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method