UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of the DPP-4 inhibitor, saxagliptin on glucose variability in type 2 diabetes patients with Chronic kidney disease
Title of the study (Brief title)	Effect of saxagliptin on glucose variability in type 2 diabetes patients with CKD
Region	Japan

Condition
Condition	Type 2 diabetes patients with CKD
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 effects of saxagliptin on glucose variability and safety in type 2 diabetes patients with or without CKD.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in Mean Amplitude of Glycemic Excursions from baseline to week 4 after the start of administration
Key secondary outcomes	Change in glucose variability and biomakers from baseline to week 4 after the start of administration

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 2.5mg or 5 mg once a day before 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. HbA1c (NGSP) >=6.5% and <10.0% 4. The patients provided written informed consent to participate in the study
Key exclusion criteria	1. Patients who have history of hypersensitivity to saxagliptin or the other dpp-4 inhibitors 2. Patients who have history of administration of incretin-related drugs within 4 weeks 3. Patients who changed anti-diabetic drugs, diet thrapy or exercise thrapy within 4 weeks 4. Patients who have end stage renal disease undergoing maintenance dialysis, or after renal transplantation 5. Patients who have history of severe ketosis, diabetic coma, or precoma within 6 months 6. Patients who have history of cancer within 5 years 7. Patients who have liver disfunction with AST or ALT>=3 x upper limit of normal 8. Patients who experienced severe traumatotherapy requiring surgery or surgery with general anesthesia within 6 months 9. Women who is pregnant or planned to become pregnant 10. Patients who are considered not eligible for the study by the attending doctor due to other reasons
Target sample size	26

Research contact person
Name of lead principal investigator	Tahashi Maruyama
Organization	Nihon University Itabashi Hospital
Division name	Division of Nephrology, Hypertension and Endocrinology
Address	30-1, Oyaguchi Kami-cho, Itabashi-ku, Tokyo
TEL	03-3972-8111
Email	maruyama.takashi@nihon-u.ac.jp

Public contact
Name of contact person	Hiroshi Fujino
Organization	Kyowa Hakko Kirin,co.,Ltd
Division name	Medical Affairs Department
Address	1-9-2, Otemachi, Chiyoda-ku, Tokyo
TEL	0352057200
Homepage URL
Email	hiroshi.fujino@kyowa-kirin.co.jp

Sponsor
Institute	Nihon University Itabashi Hospital
Institute
Department

Funding Source
Organization	Kyowa Hakko Kirin,co.,Ltd
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

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 09 Month 25 Day
Anticipated trial start date	2017 Year 04 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 03 Month 22 Day
Last modified on	2018 Year 06 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030371