UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007056 |
|---|---|
| Receipt number | R000008317 |
| Scientific Title | Multicenter,randomized,crossover clinical trial comparing the effects of Alogliptin and Sitagliptin in patients with type 2 diabetes |
| Date of disclosure of the study information | 2012/01/12 |
| Last modified on | 2016/02/15 19:16:29 |
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Basic information
Public title
Multicenter,randomized,crossover clinical trial comparing the effects of Alogliptin and Sitagliptin in patients with type 2 diabetes
Acronym
Comparison of Alogliptin and Sitagliptin in patients with type 2 diabetes
Scientific Title
Multicenter,randomized,crossover clinical trial comparing the effects of Alogliptin and Sitagliptin in patients with type 2 diabetes
Scientific Title:Acronym
Comparison of Alogliptin and Sitagliptin in patients with 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 compare the effects of Alogliptin and Sitagliptin by crossover method
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c
Key secondary outcomes
plasma glucose, C-peptide, glucagon, urinary sugar
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
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of Alogliptin 25mg in the first 4 months followed by the administration of Sitagliptin 50-100mg for 4 months
Interventions/Control_2
Administration of Sitagliptin 50-100mg in the first 4 months followed by the administration of Alogliptin 25mg for 4 months
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes treated with Sitagliptin 50-100mg
Key exclusion criteria
1)Patient who has a history of hypersensitivity against Alogliptin
2)Patient on insulin treatment
3)Patient with severe renal dysfunction or renal failure
4)Patient under 20 years old
5)Patient considered as inadequate by the principal investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuko Uchigata |
Organization
Tokyo Women's Medical University
Division name
Third Department of Medicine
Zip code
Address
8-1 Kawadacho,Shinjuku-ku,Tokyo
TEL
03-3353-8111
uchigata@dmc.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Nakagami |
Organization
Tokyo Women's Medical University
Division name
Third Department of Medicine
Zip code
Address
8-1 Kawadacho,Shinjuku-ku,Tokyo
TEL
03-3353-8111
Homepage URL
nakagami@dmc.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
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
| 2012 | Year | 01 | Month | 12 | 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
Completed
Date of protocol fixation
| 2011 | Year | 12 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 12 | Day |
Last modified on
| 2016 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008317
| Research Plan | |
|---|---|
| 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 |
