Unique ID issued by UMIN | UMIN000013022 |
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Receipt number | R000015191 |
Scientific Title | 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 |
Date of disclosure of the study information | 2014/02/01 |
Last modified on | 2014/01/30 19:02:11 |
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
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
Europe |
The licensing phase
Gastroenterology | Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Adult |
Others
NO
Is pancreatic enzyme replacement therapy in patients with diabetes mellitus and exocrine pancreatic insufficiency able to improve glucose metabolism?
Safety,Efficacy
Confirmatory
Explanatory
Phase IV
Evaluation of pancreatic enzyme replacement therapy in patients with diabetes mellitus and exocrine pancreatic insufficiency able to improve glucose metabolism.
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.
Single arm
Randomized
Individual
Double blind -all involved are blinded
Placebo
1
Treatment
Medicine |
study drug/placebo
18 | years-old | <= |
70 | years-old | >= |
Male and Female
-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
-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
120
1st name | |
Middle name | |
Last name | Laszlo Czako, MD, PhD |
First Department of Internal Medicine
Gastroenterology
University of Szeged Koranyi Fasor 8-10. Szeged 6720 Hungary
36-62-545-186
czako.laszlo@med.u-szeged.hu
1st name | |
Middle name | |
Last name | Gabor Zsori, MD |
First Department of Internal Medicine
Gastroenterology
University of Szeged Koranyi Fasor 8-10. Szeged 6720 Hungary
36-62-545-186
zsori.gabor861@gmail.com
First Department of Internal Medicine, Szeged
None
Self funding
NO
2014 | Year | 02 | Month | 01 | Day |
Unpublished
Preinitiation
2013 | Year | 11 | Month | 27 | Day |
2014 | Year | 03 | Month | 01 | Day |
2014 | Year | 01 | Month | 30 | Day |
2014 | Year | 01 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015191
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