UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003006 |
|---|---|
| Receipt number | 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 10:58:20 |
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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
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
kzhkskgc@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003640
