UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study on the effects of vildagliptin on glucose and lipid profiles in patients type 2 diabetes mellitus
Title of the study (Brief title)	Clinical study on the effects of vildagliptin on glucose and lipid profiles in patients type 2 diabetes mellitus
Region	Japan

Condition
Condition	type 2 diabetes mellitus
Classification by specialty	Medicine in general Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is,by using vlidagliptin in type 2 diabetes mellitus ,to clarify its effect of glucose reduction and to investigate the possibility of vildagliptin for taking new place of other oral antidiabetic drugs. In addition,the effect of lipid profile is to be validated.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	HbA1c
Key secondary outcomes	blood glucose lipid profile blood pressure weight blood coagulation inflammatory marker Urinary albumin-to-creatinine ratio (UACR)

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	Oral vildagliptin administration (50mg)twice daily.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)patients informed and fully understood the explanation of the study. 2)outpatients age over 20 years in type 2 diabetes melliitus 3)patients in type 2 diabetes inadequate glucose control even after dietary and exercise therapies. 4)paients in type 2 diabetes taking a oral antidiabetic drug(OAD) or taking two OADs including one sulfonylurea.
Key exclusion criteria	1)patients with hypersensitivity to targeted medication 2)type 1 diabetes, diabetic ketoacidosis or diabetic coma 3)patients with severe liver dysfunaction 4)patients with severe infection or traumatic injury 5)pregnat, female with possiboility of pregnancy and breast-feeding 6)patients with severe complications 7)any other factors that may disqualify patients
Target sample size	100

Research contact person
Name of lead principal investigator	Shigemasa Tani
Organization	Surugadai Nihon University Hospital
Division name	Department of Cardiology
Address	1-8-13 Kanda-Surugadai, Chiyoda-ku, Tokyo , Japan
TEL	+81-3-3293-1711
Email	tanishigem@yahoo.co.jp

Public contact
Name of contact person	Shigemasa Tani
Organization	Surugadai Nihon University Hospital
Division name	Department of Cardiology
Address	1-8-13 Kanda-Surugadai, Chiyoda-ku, Tokyo , Japan
TEL	+81-3-3293-1711
Homepage URL
Email	tanishigem@yahoo.co.jp

Sponsor
Institute	Department of Cardiology
Institute
Department

Funding Source
Organization	Department of Cardiology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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	駿河台日本大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2013 Year 04 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 08 Month 01 Day
Anticipated trial start date	2011 Year 09 Month 01 Day
Last follow-up date	2015 Year 03 Month 31 Day
Date of closure to data entry	2015 Year 03 Month 31 Day
Date trial data considered complete	2015 Year 03 Month 31 Day
Date analysis concluded	2015 Year 03 Month 31 Day

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

Management information
Registered date	2013 Year 04 Month 09 Day
Last modified on	2017 Year 10 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011732