UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014382 |
|---|---|
| Receipt number | 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 12:10:57 |
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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
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
asset-k@n-place.co.jp
Sponsor or person
Institute
Diabetes Committee, Kanagawa Physicians Association
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016714
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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