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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005337
Receipt No. R000006137
Scientific Title The effect on the renal functions and blood pressure of DPP-4 Inhibitor for the type 2 diabetic patients .
Date of disclosure of the study information 2011/03/29
Last modified on 2014/08/14

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Basic information
Public title The effect on the renal functions and blood pressure of DPP-4 Inhibitor for the type 2 diabetic patients .
Acronym Sitagliptin therapy for blood glucose ,BP,and renal function in type 2 diabetic patients.(STABAR)
Scientific Title The effect on the renal functions and blood pressure of DPP-4 Inhibitor for the type 2 diabetic patients .
Scientific Title:Acronym Sitagliptin therapy for blood glucose ,BP,and renal function in type 2 diabetic patients.(STABAR)
Region
Japan

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

Objectives
Narrative objectives1 To examine the effect on glucose control, the blood-pressure and the renal functions of DPP-4 Inhibitor "Sitagliptin" for type 2 diabetic patients who are inadequately controlled blood glucose level.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change from baseline in HbA1c at Month 3.
Key secondary outcomes 1)Change for the following parameters between the baseline and the after 3, 6, 9 and 12 months..
1.blood pressure at the doctor's office-visit 2.blood pressure at home in the early morning 3.urinary micro-albumin level (creatinin equivalent)
4.eGFR 5.cystatin C 6.HbA1c(except the 3 months later) 7.casual blood glucose level 8.lipid level (HDL-C,LDL-C,TG) 9.hs-CRP 10.body weight
2)Change for 24-hour blood pressure between the baseline and after 6 and 12 months
3)Safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Add-on Stagliptin (50mg ) for 12 months, after 3 months, the physician can increase the dose of Sitagliptin to 100mg or titlate the antidiabetic agent. In case of the patients with moderate renal impairment, the starting dose of Sitagliptin is 25mg, the physician may increase the maximum dose of 50 mg.
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1)Patients with type 2 diabetes (6.5%<=HbA1c<9.0%) who has suboptimal glycemic control by only with the diet and exercise therapy and or with anti-diabetic agents add-on with the diet and exercise therapy for more than 1 month treatments.
2)Patients with the age between 20-80 years old who agreed with the participation in this study with written consent.
Key exclusion criteria 1)Patients with type 1 diabetes
2)History of severe ketosis, diabetic coma or precoma within 6 months
3)Patients with severe infections, before or after operation, or with serious trauma
4)Ptientswho are pregnant, breast-feeding and/or intention to become pregnant
5)Patients with the severe renal impairment
6)Patients receiving Alfa-glycosidase inhibitor, Glinide or Insulin
7)Patients receiving DPP-4 inhibitor other than Sitagliptin
8)Patients having allergies against DPP-4 inhibitor or alfa-Glycosidase inhibitor
9)Patients determined to be inappropriate for the study by physician based on the scientific grounds.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Koya
Organization Kanazawa Medical University
Division name Diadetes & Endocrinology
Zip code
Address Daigaku1-1 Uchinadamachi Kahokugun Ishikawa
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Koya
Organization Kanazawa Medical University
Division name Diadetes & Endocrinology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Kanazawa Medical University
Diadetes & Endocrinology
Institute
Department

Funding Source
Organization Kanazawa Medical University
Diadetes & Endocrinology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2011 Year 03 Month 29 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
2011 Year 01 Month 21 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 03 Month 29 Day
Last modified on
2014 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006137

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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