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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003006
Receipt No. R000003640
Scientific Title Prospective, randomized, open-label, clinical trial comparing the different Sufonyl Urea(SU) combination with DPP4 inhibitor
Date of disclosure of the study information 2010/01/09
Last modified on 2015/01/09

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Basic information
Public title Prospective, randomized, open-label, clinical trial comparing the different Sufonyl Urea(SU) combination with DPP4 inhibitor
Acronym Prospective, randomized, open-label, clinical trial comparing the different Sufonyl Urea(SU) combination with DPP4 inhibitor
Scientific Title Prospective, randomized, open-label, clinical trial comparing the different Sufonyl Urea(SU) combination with DPP4 inhibitor
Scientific Title:Acronym Prospective, randomized, open-label, clinical trial comparing the different Sufonyl Urea(SU) combination with DPP4 inhibitor
Region
Japan

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

Objectives
Narrative objectives1 Evaluation of efficacy of different Sulfonylurea using cobination with DPP4
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Diabetic Control (HbA1c, 1,5AG)
beta cell function (proinsulin/ insulin ratio, CPR index)
Key secondary outcomes systolic BP, diastolic BP
LDL-cho, HDL-cho, TG

Base
Study type Interventional

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

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 after using gliclazide for 3 months, then substitute to glibenclamide
Interventions/Control_2 after using glibenclamide for 3 months,then substitute to gliclazide
Interventions/Control_3 after glimepiride for 3 months, then substitute to gliclazide
Interventions/Control_4 after gliclazide for 3 months, then substitute to glimepiride
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 Type2 Diabetes initiated to use sitagliptin(DPP4 inhibitor)
and
mean HbA1c 6.5%-7.5% for 3months
and
when gliclazide, daily dose within 40mg
when glimepiride, daily dose within 1 mg
when glibenclamide, daily dose within 1.25 mg
Key exclusion criteria 1.History of hypersensitivity to sulfonyl urea or sitagliptin
2.During the pregnancy and nursing
3. Severe renal dysfunction (serum creatinin>2.0mg/dl)
4. Severe liver dysfunction (AST, ALT>50IU/ml)
5.
6.Inadequate to entry this study
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Sakaguchi
Organization Kobe University Graduate School of Medicine
Division name Division of Diabetes,Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiko Sakaguchi
Organization Kobe University Graduate School of Medicine
Division name Division of Diabetes,Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017
TEL
Homepage URL
Email kzhkskgc@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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 神戸大学医学部付属病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 09 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 Terminated
Date of protocol fixation
2010 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
2012 Year 06 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 01 Month 09 Day
Last modified on
2015 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003640

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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