UMIN-CTR Clinical Trial

Basic information
Public title	The effects of vildagliptin in addition to insulin on glycemic control in hemodialysis patients with type 2 diabetes mellitus
Acronym	The effects of vildagliptin in addition to insulin on glycemic control in hemodialysis patients with type 2 diabetes mellitus
Scientific Title	The effects of vildagliptin in addition to insulin on glycemic control in hemodialysis patients with type 2 diabetes mellitus
Scientific Title:Acronym	The effects of vildagliptin in addition to insulin on glycemic control in hemodialysis patients with type 2 diabetes mellitus
Region	Japan

Condition
Condition	type 2 diabetes mellitus undergoing hemodialysis
Classification by specialty	Endocrinology and Metabolism Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the effect of vildagliptin addition to insulin on glycemic control in hemodialysis patients with type 2 diabetes mellitus.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Total daily dose of insulin and HbA1c(NGSP) at 0, 12 and 24 weeks after administration of vildagliptin Mean amplitude of glycemic excursions Safety and adherence
Key secondary outcomes	Events of hypoglycemia Body weight

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)The patient who have poor glycemic control undergoing insulin therapy or judged that it was expectable to reduce the insulin dose in addition to vildagliptin 2)CPI<0.8
Key exclusion criteria	1) Severe ketosis, or diabetic coma or precoma, type1 diabetes 2) Severe liver dysfunction 3) Diarrhea or vomiting 4) Severe infection, before and after surgery, or severe trauma 5) History of lactic acidosis or pancreatitis 6) Severe cardiac or pulmonary dysfunction, such as shock, heart failure, myocardial infarction, and pulmonary embolism. 7) Dehydration 8) History of severe alcoholic abuse 9) Malnutrition, starvation, debility, pituitary dysfunction, and adrenal insufficiency 10) Pregnant female, female with possibility of pregnancy 11) Malignancy 12) History of hypersensitivity to targeted medication 13) Patients inappropriate for medical reason
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuaki Soejima
Organization	Saiseikai Kumamoto Hospital
Division name	Kidney and Urology center
Zip code
Address	5-3-1 Chikami Minami-ku Kumamoto
TEL	096-351-8000
Email	kazuaki-soejima@saiseikaikumamoto.jp

Public contact
Name of contact person	1st name Middle name Last name Hironobu Inoue
Organization	Saiseikai Kumamoto Hospital
Division name	Kidney and Urology center
Zip code
Address	5-3-1 Chikami Minami-ku Kumamoto
TEL	096-351-8000
Homepage URL
Email	hironobu-inoue@saiseiakikumamoto.jp

Sponsor
Institute	Saiseikai Kumamoto Hospital
Institute
Department

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	済生会熊本病院

Other administrative information
Date of disclosure of the study information	2013 Year 05 Month 13 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	Completed
Date of protocol fixation	2013 Year 05 Month 01 Day
Date of IRB	2013 Year 05 Month 13 Day
Anticipated trial start date	2013 Year 05 Month 13 Day
Last follow-up date	2014 Year 05 Month 13 Day
Date of closure to data entry	2014 Year 05 Month 13 Day
Date trial data considered complete	2014 Year 05 Month 13 Day
Date analysis concluded	2014 Year 12 Month 31 Day

Other
Other related information	The purpose of this study is to evaluate the effect of vildagliptin addition to insulin on glycemic control in hemodialysis patients with type 2 diabetes mellitus.

Management information
Registered date	2013 Year 05 Month 13 Day
Last modified on	2019 Year 10 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012509