UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013022
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

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Basic information

Public 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

Acronym

Pancreatic enzyme replacement therapy in diabetes mellitus and exocrine pancreatic insufficiency

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

Scientific Title:Acronym

Pancreatic enzyme replacement therapy in diabetes mellitus and exocrine pancreatic insufficiency

Region

Europe


Condition

Condition

The licensing phase

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Is pancreatic enzyme replacement therapy in patients with diabetes mellitus and exocrine pancreatic insufficiency able to improve glucose metabolism?

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase IV


Assessment

Primary outcomes

Evaluation of pancreatic enzyme replacement therapy in patients with diabetes mellitus and exocrine pancreatic insufficiency able to improve glucose metabolism.

Key secondary outcomes

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.


Base

Study type


Study design

Basic design

Single arm

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

study drug/placebo

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit

70 years-old >=

Gender

Male and Female

Key inclusion criteria

-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

Key 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

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Laszlo Czako, MD, PhD

Organization

First Department of Internal Medicine

Division name

Gastroenterology

Zip code


Address

University of Szeged Koranyi Fasor 8-10. Szeged 6720 Hungary

TEL

36-62-545-186

Email

czako.laszlo@med.u-szeged.hu


Public contact

Name of contact person

1st name
Middle name
Last name Gabor Zsori, MD

Organization

First Department of Internal Medicine

Division name

Gastroenterology

Zip code


Address

University of Szeged Koranyi Fasor 8-10. Szeged 6720 Hungary

TEL

36-62-545-186

Homepage URL


Email

zsori.gabor861@gmail.com


Sponsor or person

Institute

First Department of Internal Medicine, Szeged

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2014 Year 02 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2013 Year 11 Month 27 Day

Date of IRB


Anticipated trial start date

2014 Year 03 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 01 Month 30 Day

Last modified on

2014 Year 01 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015191


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name