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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000014382
Receipt No. R000016714
Scientific Title A Study of Safety and Efficacy of DPP-4 inhibitor in the Treatment of type 2 diabetes in Kanagawa
Date of disclosure of the study information 2014/06/27
Last modified on 2018/12/28

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Basic information
Public title A Study of Safety and Efficacy of DPP-4 inhibitor in the Treatment of type 2 diabetes in Kanagawa
Acronym ASSET-K
Scientific Title A Study of Safety and Efficacy of DPP-4 inhibitor in the Treatment of type 2 diabetes in Kanagawa
Scientific Title:Acronym 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
1st name
Middle name
Last name Akira Kubota
Organization Kubota clinic of Internal Medicine
Division name Director
Zip code
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
1st name
Middle name
Last name Kou Kayukawa
Organization Nouvelle Place Inc
Division name R.M.O
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.jstage.jst.go.jp/article/tonyobyo/61/11/61_773/_article/-char/ja
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2014 Year 05 Month 22 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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