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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000004985
Receipt No. R000005919
Scientific Title The effect of sitagliptin on pancreatic beta-cell protection for the type 2 diabetic patients treated with sulfonylurea : a prospective randomized, multicenter, open-label, comparative study.
Date of disclosure of the study information 2011/02/01
Last modified on 2011/01/31

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Basic information
Public title The effect of sitagliptin on pancreatic beta-cell protection for the type 2 diabetic patients treated with sulfonylurea : a prospective randomized, multicenter, open-label, comparative study.
Acronym Sitagliptin vs. Step-up SU Study for the protection of beta-cell in Shinshu (SSSSS)
Scientific Title The effect of sitagliptin on pancreatic beta-cell protection for the type 2 diabetic patients treated with sulfonylurea : a prospective randomized, multicenter, open-label, comparative study.
Scientific Title:Acronym Sitagliptin vs. Step-up SU Study for the protection of beta-cell in Shinshu (SSSSS)
Region
Japan

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

Objectives
Narrative objectives1 To compare the effect of sulfonylurea uptitration versus add-on sitagliptin on pancreatic beta-cell protection for type 2 diabetic patient inadequately controlled by sulfonylurea.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Pancreatic beta-cell protection ( Serum C peptide, Intact proinsulin/Insulin ratio )
Key secondary outcomes HbA1c, fasting plasma glucose, HOMA-beta, Insulinogenic Index, Total cholesterol, triglyceride, HDL cholesterol, BNP, cystatin C, urinary albumin/creatinin ratio, body weight, adherence

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Titration of Glimepiride
Interventions/Control_2 Add-on Stagliptin
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1. Patients with type 2 diabetes who is treated by Glimepiride less than 2mg/day for more than 4 weeks.
2. Age >= 20 years, <75 years, Male and Female
3. HbA1c >= 7.0%, <9.0% JDS
Key exclusion criteria 1. Patients with renal failure.
2. Patients with cancer.
3. Patients with nephropathy more than 3b period.
4. Patients with preproliferative or proliferative retinopathy.
5. Other patients determined to be inappropriate by physician.
Target sample size 240

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuhisa Komatsu
Organization Shinshu University Graduate School, Devision of Medicine
Division name Department of Aging Medicine and Geriatrics
Zip code
Address 3-1-1 Asahi, Matsumoto-city, Nagano, 390-8621 JAPAN
TEL 0263-37-2686
Email

Public contact
Name of contact person
1st name
Middle name
Last name Teiji Takeda
Organization Shinshu University Graduate School, Devision of Medicine
Division name Department of Aging Medicine and Geriatrics
Zip code
Address 3-1-1 Asahi, Matsumoto-city, Nagano, 390-8621 JAPAN
TEL 0263-37-2686
Homepage URL
Email

Sponsor
Institute Shinshu University Graduate School, Devision of Medicine, Department of Aging Medicine and Geriatrics
Institute
Department

Funding Source
Organization The society for diabetes of Japanese
Organization
Division
Category of Funding Organization Other
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 信州大学医学部附属病院(長野県)、小諸厚生病院(長野県)、岡谷市民病院(長野県)、千曲中央病院(長野県)、飯田市立病院(長野県)、長野市民病院(長野県)、国保浅間総合病院(長野県)、長野中央病院(長野県)、松本医療センター(長野県)、諏訪赤十字病院(長野県)、富士見高原病院(長野県)、篠ノ井総合病院(長野県)、伊那中央病院(長野県)、市立波田病院(長野県)

Other administrative information
Date of disclosure of the study information
2011 Year 02 Month 01 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 Preinitiation
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 01 Month 31 Day
Last modified on
2011 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005919

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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