UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of saxagliptin on endothelial function in patients with type 2 diabetes; Multi-center clinical trial
Title of the study (Brief title)	Effect of saxagliptin on endothelial function in patients with type 2 diabetes; Multi-center clinical trial
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the effects of saxagliptin on endothelial function in patients with type 2 diabetes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in FMD from baseline to week 12
Key secondary outcomes

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	Administration of saxagliptin 5 mg once a day post breakfast.
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. Type 2 diabetes 2. >=20 of age at the time of informed consent acquisition 3. Type 2 diabetes with HbA1c (NGSP) >=7.0% and <9.0% 4.The patient provided written informed consent to participate in the study
Key exclusion criteria	1. Has history of hypersensitivity to ipragliflozin or any other excipient of saxagliptin 2. Has history of administration of DPP-4 inhibitor within 4 weeks before initiation of the study 3.patient with insulin dependent diabetes mellitus 4. Has history of myocardial infarction, angina, cerebral infarction, intracranial hemorrhage, subarachnoid hemorrhage, transient ischemic attacks within 3 months before initiation of the study 5. patient with ASO 6. With severe renal dysfunction (eGRF <50 mL/min or patient undergoing artificial dialysis) 7. Has history of severe ketosis, diabetic coma, or precoma within 6 months 8. Has history of cancer, severe infection 9. Pregnant, possibly pregnant, planned to become pregnant or nursing women 10. Are considered not eligible for the study by the attending doctor due to other reasons
Target sample size	40

Research contact person
Name of lead principal investigator	Yukihito Higashi
Organization	Hiroshima University Hospital
Division name	Medical Center for Translational and Clinical Research
Address	1-2-3 Kasumi, Minamiku, Hiroshima
TEL	082-257-5831
Email	yhigashi@hiroshima-u.ac.jp

Public contact
Name of contact person	Yukihito Higashi
Organization	Hiroshima University Hospital
Division name	Medical Center for Translational and Clinical Research
Address	1-2-3 Kasumi, Minamiku, Hiroshima
TEL	082-257-5831
Homepage URL
Email	yhigashi@hiroshima-u.ac.jp

Sponsor
Institute	Medical Center for Translational and Clinical Research, Hiroshima University Hospital
Institute
Department

Funding Source
Organization	KYOWA KIRIN.
Organization
Division
Category of Funding Organization	Profit organization
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	東京医科大学（東京都）、日本大学（東京都）、徳島大学（徳島）

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 14 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2017 Year 10 Month 02 Day
Date of closure to data entry	2017 Year 11 Month 09 Day
Date trial data considered complete	2018 Year 03 Month 12 Day
Date analysis concluded	2018 Year 06 Month 08 Day

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

Management information
Registered date	2016 Year 03 Month 17 Day
Last modified on	2018 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023879