UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011788 |
|---|---|
| Receipt number | R000013781 |
| Scientific Title | The efficacy of DPP-4 inhibitors and alpha glucosidase inhibitors for type 2diabetes |
| Date of disclosure of the study information | 2013/09/18 |
| Last modified on | 2013/09/25 09:08:43 |
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Basic information
Public title
The efficacy of DPP-4 inhibitors and alpha glucosidase inhibitors for type 2diabetes
Acronym
The efficacy of DPP-4 inhibitors and alpha glucosidase inhibitors for type 2diabetes
Scientific Title
The efficacy of DPP-4 inhibitors and alpha glucosidase inhibitors for type 2diabetes
Scientific Title:Acronym
The efficacy of DPP-4 inhibitors and alpha glucosidase inhibitors for type 2diabetes
Region
| Japan |
Condition
Condition
Patients with type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of coadministration of DPP-4 inhibitors and alpha glucosidase inhibitors
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Markers for glucose metabolism and incretin related hormones
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 (sitagliptin and miglitol)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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Japanese patients with type 2 diabetes who were treated with diet therapy alone or with oral hypoglycemic agents other than alpha-GIs or DPP-4 inhibitors,
Key exclusion criteria
Patients with severe liver dysfunction or renal dysfunction.
Target sample size
15
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, D
Zip code
Address
1-21-1 Toyama, Shinjuku-ku,To
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
the Joint Research Association for Japanese Diabetes.
Organization
Division
Category of Funding Organization
Non profit foundation
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 | 18 | 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
Completed
Date of protocol fixation
| 2010 | Year | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | 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
| 2013 | Year | 09 | Month | 18 | Day |
Last modified on
| 2013 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013781
