UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of vildagliptin and alogliptin in patient with type 2 diabetes
Title of the study (Brief title)	Comparison of vildagliptin and alogliptin
Region	Japan

Condition
Condition	Type 2 diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to compare the effect of vildagliptin and alogliptin swithed from sitagliptin on glycemic control in patients with type 2 diabetes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Achievement rate of HbA1c <6.6%
Key secondary outcomes	1) Achievement rate of blood glucose <130mg/dl 2) Achievement rate of HbA1c <6.5% by sitagliptin treatment 3)Durability of vildagliptin or alogliptin

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Vildagliptin 100mg/day for 3 months
Interventions/Control_2	alogliptin 20mg/day for 3 monts
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	1)Outpatients who have been taking 50mg of sitagliptin for 1month or monre 2)3)Type 2 diabete mellitus (HbA1c level:more than 6.6%, less than 9.1% 4)Pts with written IC 5)Age more than 20, less than 85
Key exclusion criteria	1)severe ketosis, diabetic coma within 6 months 2)severe infection, before operation, severe trauma 3)severe hepatic dysfunction 4) severe renal dysfunction (sCr: more than 1.5mg/dl) 5)Patients who use of insulin 6)regnacy 7)Allergy for vildagliptin or alogliptin 8)Patients judged by the investigator to be ineligible for some other reason
Target sample size	70

Research contact person
Name of lead principal investigator	Tadashi Yamakawa
Organization	Yokohama City University Medical Center
Division name	Department of Endocrinology and Diabetes
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Email	yamakat@urahp.yokohama-cu.ac.jp

Public contact
Name of contact person	Erina Shigematu
Organization	Yokohama City University Medical Center
Division name	Department of Endocrinology and Diabetes
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Homepage URL
Email	erina-sgmt@live.jp

Sponsor
Institute	Yokohama City University Medical Center
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)

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	横浜市立大学附属市民総合医療センター（神奈川県）

Other administrative information
Date of disclosure of the study information	2011 Year 06 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 06 Month 20 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 06 Month 20 Day
Last modified on	2017 Year 06 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006873