UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of alogliptin/pioglitazone on endothelial function and Visceral fat of Type 2Diabetes
Title of the study (Brief title)	Effect of alogliptin/pioglitazone on endothelial function and Visceral fat of Type 2Diabetes
Region	Japan

Condition
Condition	Type2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effect of pioglitazone or sulfonylurea on endothelial function and Visceral fat of Type 2 diabetes who treated alogliptin.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Endothelial function after 6 months on pioglitazone or sulfonylurea
Key secondary outcomes	The change of body weight,blood pressure,visceral fat HbA1c,blood glucose,LDL,HDL,non HDL,adiponectin,and 8epiPGF2A after 6 months treatment of pioglitazone or sulfonylurea

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	pioglitazone15mg 6months
Interventions/Control_2	sulfonylurea 6months
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	Type2 diabetes treated with alogliptin (including treated another antidiabetic drugs and insulin )
Key exclusion criteria	1)Patients with hypersensitivity to the components of alogliptin or sulfonylurea. 2)Patients with severe ketosis ,diabetic coma or pre coma. 3)Patients with severe infection,before and after surgery,severe trauma. 4)Patient with advanced renal dysfunction(eGFR<30) or patient on dialysis. 5)Patients with severe liver dysfunction. 6)Patients with pregnancy or possibility. 7)Patients whom physician in charge considered inappropriate for study.
Target sample size	30

Research contact person
Name of lead principal investigator	Yoshimasa Aso
Organization	Dokkyo medical university hospital
Division name	Endocrinology and Metabolism
Address	880,Kitakobayashi,Mibu,Shimotsugagun,Tochigi
TEL	0282-86-1111
Email	yaso@dokkyomed.ac.jp

Public contact
Name of contact person	Chie Aoki
Organization	Dokkyo medical university hospital
Division name	Endocrinology and Metabolism
Address	880,Kitakobayashi,Mibu,Shimotsugagun,Tochigi
TEL	0282-86-1111
Homepage URL
Email	c-aoki@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo medical university hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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	2016 Year 08 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 08 Month 03 Day
Last follow-up date	2017 Year 03 Month 31 Day
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	2016 Year 08 Month 03 Day
Last modified on	2018 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027009