UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003057 |
|---|---|
| Receipt number | R000003710 |
| Scientific Title | A study on efficacy and safety of a DPP-IV inhibitor in type 2 diabetes patients |
| Date of disclosure of the study information | 2010/01/19 |
| Last modified on | 2012/02/20 14:14:12 |
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Basic information
Public title
A study on efficacy and safety of a DPP-IV inhibitor in type 2 diabetes patients
Acronym
Saga-challenge antiDiabetes
Observantional study for sitaGliptin
(S-DOG)
Scientific Title
A study on efficacy and safety of a DPP-IV inhibitor in type 2 diabetes patients
Scientific Title:Acronym
Saga-challenge antiDiabetes
Observantional study for sitaGliptin
(S-DOG)
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To carry out treatment with a DPP-IV inhibitor as part of an intensified treatment regimen for patients with type 2 diabetes whose glycemic control is inadequate in order to examine its efficacy, safety and effects on QOL.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Change and % change in HbA1c at 3 months after study initiation.
Key secondary outcomes
- Change and % change in HbA1c (excluding values at 3 months), HOMA-beta, TC, HDL-C, TG and body weight at 3, 6, 9 and 12 months after study initiation
- Change and % change in EQ5D and PSQI scores at 3 and 12 months after study initiation
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
Aggressive antiglycaemic therapy is to be administered by using sitagliptin
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 patients diagnosed according to the clinical diagnostic criteria of the Japan Diabetes Society
2) Patients aged >=20 years
3) Patients who fully understand the study procedures and have given written informed consent on use of their data for the study
Key exclusion criteria
1) Patient with a history of severe ketosis, diabetic coma or pre-coma within the past 6 months
2) Patient with severe infection, a recent history of surgery, and those who are scheduled to undergo surgery soon, or serious external wound
3) Pregnant patients, including one trying to conceive pregnancy during the planned study period, and breast-feeding patients
4) Patients with modest to severe renal impairment (creatinine clearance >=30 mL/min; serum creatinine >=1.5mg/dL in men and >=1.3mg/dL in women)
5) Patients with a history of hypersensitivity to the study agent
6) Patients who are considered not eligible for the study by the attending doctor due to medical reasons
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Node |
Organization
Saga University Faculty of Medicine
Division name
Department of Cardiovascular and Renal medicine
Zip code
Address
5-1-1 Nabeshima, Saga-shi, Saga
TEL
0952-34-2364
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichi Oyama |
Organization
Saga lifestyle related disease treatment study group
Division name
secretariat
Zip code
Address
Department of Cardiovascular, Saga University Faculty of Medicine, 5-1-1Nabeshima, Saga-shi, Saga
TEL
0952-34-2364
Homepage URL
Sponsor or person
Institute
Saga lifestyle related disease treatment study group secretariat
Institute
Department
Personal name
Funding Source
Organization
Medicine foundation (An application for a research grant has been submitted)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
佐賀大学医学部（佐賀県）、池田内科・皮フ科医院（佐賀県）、江口病院（佐賀県）、
佐賀記念病院（佐賀県）、権藤医院（佐賀県）、伊万里市立市民病院（佐賀県）、神埼クリニック（佐賀県）、内藤医院北山診療所（佐賀県）、高橋内科（佐賀県）、貝原医院（佐賀県）、水上医院（佐賀県）、古賀病院（佐賀県）、武田内科医院（佐賀県）、田尻外科胃腸科医院（佐賀県）、夢咲クリニック（佐賀県）、神埼病院（佐賀県）、南医院（佐賀県）、蒲地医院（佐賀県）、脇山内科（佐賀県）、ひらまつふれあいクリニック（佐賀県）、内田クリニック（佐賀県）、佐賀市立富士大和温泉病院（佐賀県）、中尾胃腸科医院（佐賀県）、岩本内科（佐賀県）、中西内科（佐賀県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 01 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
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
Completed
Date of protocol fixation
| 2009 | Year | 12 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 01 | Month | 19 | Day |
Last modified on
| 2012 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003710
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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