UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009908 |
|---|---|
| Receipt number | R000011609 |
| Scientific Title | In combination therapy with insulin and DPP-4 inhibitor sitagliptin Study of efficacy and safety |
| Date of disclosure of the study information | 2013/01/30 |
| Last modified on | 2013/01/30 18:49:26 |
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Basic information
Public title
In combination therapy with insulin and DPP-4 inhibitor sitagliptin
Study of efficacy and safety
Acronym
In combination therapy with insulin and DPP-4 inhibitor sitagliptin
Study of efficacy and safety
Scientific Title
In combination therapy with insulin and DPP-4 inhibitor sitagliptin
Study of efficacy and safety
Scientific Title:Acronym
In combination therapy with insulin and DPP-4 inhibitor sitagliptin
Study of efficacy and safety
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study the efficacy and safety of sitagliptin added to the administration in patients with type 2 diabetes treated with insulin
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
HbA1c
Key secondary outcomes
C peptide
Glucagon
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years old or older at the time of obtaining consent
Patients who give written consent of their own free will after receiving a sufficient explanation of the study and fully understanding the study before participation.
Key exclusion criteria
Medical history of hypersensitivity to sitagliptin
Age below 20years old at the time of obtaining consent
Judgment of ineligibility to be a subject by the principle investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuko Uchigata |
Organization
Tokyo Women's Medical University
Division name
Diabetes Center
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo,
TEL
03-3353-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Nakagami |
Organization
Tokyo Women's Medical University
Division name
Diabetes Center
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo,
TEL
03-3353-8111
Homepage URL
nakagami@dmc.twmu.ac.jp
Sponsor or person
Institute
Diabetes Center,Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Diabetes Center,Tokyo Women's Medical University
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
東京女子医科大学病院（東京都） Tokyo womens medical university
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 30 | 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 | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | 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
Prospective observational study
Management information
Registered date
| 2013 | Year | 01 | Month | 30 | Day |
Last modified on
| 2013 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011609
