UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Study of Safety and Efficacy of DPP-4 inhibitor in the Treatment of type 2 diabetes in Kanagawa
Title of the study (Brief title)	ASSET-K
Region	Japan

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

Objectives
Narrative objectives1	We research the long-term efficacy and safety of sitagliptin after 4-5 years treatment in Japanese type 2 diabetes patients. (Retrospective Study)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes of HbA1c
Key secondary outcomes	1)Change of fasting plasma glucose level, body weight, Serum lipids [TC, HDL-C, TG, LDL-C], serum creatinine, office blood pressure,AST,ALT,gamma-GTP,BUN,uric acid,urine protein, 2)adverse events

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 diabetic outpatients 2) Patients treated with Sitagliptin for more than 4-5 years whose blood sugar control is inadequate 3) Patients aged >=20 years
Key exclusion criteria	1) Patients with a history of hypersensitivity to Sitagliptin 2) Patients who have history of diabetic ketoacidosis, or diabetic coma in the past 6 months 3) Patients with serious infectious disease, before operation, serious trauma 4) Patients with severe renal failure
Target sample size	860

Research contact person
Name of lead principal investigator	Akira Kubota
Organization	Kubota clinic of Internal Medicine
Division name	Director
Address	2708-1 Noborito,tama-ku,Kawasaki,Kanagawa
TEL	044-932-0161
Email	kubota@sj8.so-net.ne.jp

Public contact
Name of contact person	Kou Kayukawa
Organization	Nouvelle Place Inc
Division name	R.M.O
Address	Yushima 1-chome Building,1-6-3 Yushima, bunkyo-ku,Tokyo
TEL	03-3814-1616
Homepage URL
Email	asset-k@n-place.co.jp

Sponsor
Institute	Diabetes Committee, Kanagawa Physicians Association
Institute
Department

Funding Source
Organization	The Waksman Foundation of Japan
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	ASSET-K investigators
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	ASSET-K研究グループ(神奈川県)：松葉医院,かなもり内科,神内科,いしかわ内科クリニック,たくま幸クリニック,高井内科クリニック,笹井医院,雨宮内科医院,的場内科クリニック,本厚木メディカルクリニック,センター北伊藤内科,川田医院,港南台家光クリニック,H.E.Cサイエンスクリニック,くぬぎ台診療所,みながわ内科クリニック,おばな内科クリニック,もくぼ内科クリニック,向ヶ丘久保田内科,宮入内科,衣笠病院,横須賀市立市民病院,早稲田医院,ほしの内科クリニック,まちむら内科クリニック,武田クリニック,もとみや内科クリニック,かねしろ内科クリニック,鶴間かねしろ内科クリニック

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 27 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 05 Month 22 Day
Anticipated trial start date	2014 Year 06 Month 12 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete	2016 Year 03 Month 31 Day
Date analysis concluded	2016 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.jstage.jst.go.jp/article/tonyobyo/61/11/61_773/_article/-char/ja
Results
Other related information	Observational study

Management information
Registered date	2014 Year 06 Month 26 Day
Last modified on	2018 Year 12 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016714