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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003057
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Saga lifestyle related disease treatment study group secretariat
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003710

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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