UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010051 |
|---|---|
| Receipt number | R000011735 |
| Scientific Title | Combined efficacy of DPP-4 inhibitor in type 2 diabetic patients in the medical treatment of Sulfonylurea |
| Date of disclosure of the study information | 2013/02/28 |
| Last modified on | 2015/06/10 15:46:41 |
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Basic information
Public title
Combined efficacy of DPP-4 inhibitor in type 2 diabetic patients in the medical treatment of Sulfonylurea
Acronym
Combined efficacy of DPP-4 inhibitor in type 2 diabetic patients in the medical treatment of Sulfonylurea
Scientific Title
Combined efficacy of DPP-4 inhibitor in type 2 diabetic patients in the medical treatment of Sulfonylurea
Scientific Title:Acronym
Combined efficacy of DPP-4 inhibitor in type 2 diabetic patients in the medical treatment of Sulfonylurea
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To cofirm combined efficacy of DPP-4 inhibitor in type 2 diabetic patients in the medical treatment of Sulfonylurea
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Change in HbA1c
Change in weight
Incidence of hypoglycemia
Key secondary outcomes
Change in fasting insulin level
Change in fasting blood glucose level
Treatment compliance
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Glimepiride and Sitagliptin
Interventions/Control_2
Increase the amount of Glimepiride
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
Type 2 diabetes patients with inadequate glycemic control Sulfonylurea(Glimepiride:1 or 2mg once a day) monotherapy (HbA1c:6.9% or more, less than 10.5%)
Key exclusion criteria
Patients with type 1 diabetes
Patients with a history of severe ketosis, diabetic coma or pre-coma within the past six months
Patients with severe infection, before and after surgery, or severe trauma
Patients with moderate renal impairment or more(serum creatinine level:1.5mg/dl or more(male),1.3mg/dl or more(female))
Patients in the insulin therapy, rapid insulin secretagogue, or alpha-glucosidase inhibitor
Patients with a planned pregnancy or likely to be pregnant or lactating patients, or pregnant patients
Patients with a history of hypersensitivity to study drug
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichiro Yasuda |
Organization
Osaka Saiseikai Noe Hospital
Division name
Department of diabetes and endocrinology
Zip code
Address
1-3-25, Furuichi, Jyoto-ku, Osaka-shi, Osaka, 536-0001, Japan
TEL
06-6932-0401
kyasuda@noe.saiseikai.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoya Koie |
Organization
Osaka Saiseikai Noe Hospital
Division name
Department of diabetes and endocrinology
Zip code
Address
1-3-25, Furuichi, Jyoto-ku, Osaka-shi, Osaka, 536-0001, Japan
TEL
06-6932-0401
Homepage URL
motoya.koie@noe.saiseikai.or.jp
Sponsor or person
Institute
Osaka Saiseikai Noe Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Vascular Disease Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
大阪府済生会野江病院（大阪府）、高石市立診療センター（大阪府）、中村病院（大阪府）、彦根市立病院（滋賀県）、枚方公済病院（大阪府）
Osaka Saiseikai Noe Hospital(Osaka), Takaishi city medical&clinical care center(Osaka), Nakamura Hospital(Osaka), Hikone Municipal Hospital(Shiga), Hirakata kohsai Hospital(Osaka)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The 55th Annual Meeting of the Japan Diabetes Society
The 56th Annual Meeting of the Japan Diabetes Society
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
Main results already published
Date of protocol fixation
| 2011 | Year | 04 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 15 | Day |
Last modified on
| 2015 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011735
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
