UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of dipeptidyl peptidase-4 inhibitor to the additional secretion of insulin in type 2 diabetic patients on hemodialysis
Title of the study (Brief title)	Effect of dipeptidyl peptidase-4 inhibitor to the additional secretion of insulin in type 2 diabetic patients on hemodialysis
Region	Japan

Condition
Condition	Type 2 diabetic patients on hemodialysis
Classification by specialty	Endocrinology and Metabolism Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The investigation of the effect of dipeptidyl peptidase-4 inhibitor to the additional secretion of insulin in type 2 diabetic patients on hemodialysis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in levels of HbA1c(JDS), glycoalbumin, plasma glucose along with the comparison of the results obtained from glucagon load test and 75g oral glucose tolerance test after 12weeks treatment from the baseline.
Key secondary outcomes	Changes in serum levels of inflammatory markers, body weight, body fat percentage, skeletal muscle mass measured with In Body S20.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Observation span : 12 weeks Intervention : Vildagliptin (Equa) Dose : 50mg once daily for a week after starting and 50mg twice daily after 2weeks
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Type 2 diabetic patients on hemodialysis with only dietary therapy who showed HbA1c(JDS) <8.0% and postprandial glucose concentration >180mg/dl
Key exclusion criteria	(1)Type 2 diabetic patients who received insulin therapy or oral hypoglycemic agents or Liraglutide. (2) Type 2 diabetic patients who have been treated with DPP-4 inhibitor. (3) Type 1 diabetic patients. (4) Patients who develop serious hyperglycemia or diabetic ketoacidosis. (5) Patients with nephrotic syndrome. (6) Patients with treatments of steroids or immunosuppressive agents or antifungal or HIV protease inhibitors. (7) Patients with severe complications in cardiovascular system within 6 months before study entry. (8) Patients with liver diseases. (9) Patients with cancer diseases. (10) Patients with pregnancy , possibility of pregnancy . (11) Patients who are deemed to be inappropriate by the investigators.
Target sample size	5

Research contact person
Name of lead principal investigator	Yoshikazu Tamori
Organization	Chibune general hospital
Division name	Endocrinology and Metabolism
Address	2-2-45 Tsukuda, Nisiyodogawa-ku, Osaka, Japan
TEL
Email

Public contact
Name of contact person	Sachie Hirose
Organization	Chibune general hospital
Division name	Nephrology
Address	2-2-45 Tsukuda, Nisiyodogawa-ku, Osaka, Japan
TEL	06-6471-9541
Homepage URL
Email

Sponsor
Institute	Chibune general hospital
Institute
Department

Funding Source
Organization	Chibune general hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2011 Year 07 Month 25 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2011 Year 07 Month 01 Day
Anticipated trial start date	2011 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 07 Month 22 Day
Last modified on	2017 Year 01 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007128