UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011815 |
|---|---|
| Receipt number | R000013812 |
| Scientific Title | Efficacy of combination therapy of DPP-4 inhibitor and alpha glucosidase inhibitor in insurin treaaed type 2 diabetes. |
| Date of disclosure of the study information | 2013/09/19 |
| Last modified on | 2014/12/31 14:02:23 |
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Basic information
Public title
Efficacy of combination therapy of DPP-4 inhibitor and alpha glucosidase inhibitor in insurin treaaed type 2 diabetes.
Acronym
Efficacy of combination therapy of DPP-4 inhibitor and alpha glucosidase inhibitor in insurin treaaed type 2 diabetes.
Scientific Title
Efficacy of combination therapy of DPP-4 inhibitor and alpha glucosidase inhibitor in insurin treaaed type 2 diabetes.
Scientific Title:Acronym
Efficacy of combination therapy of DPP-4 inhibitor and alpha glucosidase inhibitor in insurin treaaed type 2 diabetes.
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of drugs using markers for glucose metabolism and incretin related markers
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CGM results and the values of markers for glycemic control
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Drug administration
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 daibetes who have not been treated with DPP-4 inhibitors or alpha glucosidase inhibitors
Key exclusion criteria
Patients with severe liver dysfunction and renal dysfunction
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Miyako Kishimoto |
Organization
National Center for Global Health and Medicine
Division name
Department of Endocrinology, Diabetes, and Metabolism
Zip code
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, Japan
TEL
+81-3-3202-7181
mkishimo@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miyako Kishimoto |
Organization
National Center for Global Health and Medicine
Division name
Department of Endocrinology, Diabetes, and Metabolism
Zip code
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, Japan
TEL
+81-3-3202-7181
Homepage URL
mkishimo@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2013 | Year | 09 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2013 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 23 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 19 | Day |
Last modified on
| 2014 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013812
