UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016645 |
|---|---|
| Receipt number | R000014559 |
| Scientific Title | Prospective Observational study of Sitagliptin in Subjects with type 2 Diabetes and Chronic Renal Failure |
| Date of disclosure of the study information | 2015/02/26 |
| Last modified on | 2018/03/01 10:55:46 |
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Basic information
Public title
Prospective Observational study of Sitagliptin in Subjects with type 2 Diabetes and Chronic Renal Failure
Acronym
POSEIDON Study
Scientific Title
Prospective Observational study of Sitagliptin in Subjects with type 2 Diabetes and Chronic Renal Failure
Scientific Title:Acronym
POSEIDON Study
Region
| Japan |
Condition
Condition
Type 2 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The efficacy and safety of sitagliptin in type 2 diabetes patients with chronic renal failure will be investigated prospectively.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the HbA1c or glycated albumin level at 3 and 6 months after sitagliptin treatment initiation.
Adverse events including hypoglycemia and those rates of occurrence
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes patients with chronic renal failure who were newly started sitagliptin administration from Nov. 1st in 2013
Key exclusion criteria
1) Hypersensitivity to sitagliptin
2) Patients who had severe ketosis or diabetic coma within 6 months
3) Severe infection or trauma, perioperative
4) Receiving glinide therapy
5) Patients whose participation is deemed inappropriate at the discretion of the attending physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenro Nishida |
Organization
Kumamoto Chuo Hospital
Division name
Department of Diabetes and Endocrinology
Zip code
Address
1-5-1,Taijima, Minami-ku, Kumamoto-shi, Kumamoto, Japan
TEL
096-370-3111
knishida@orange.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenro Nishida |
Organization
Kumamoto Chuo Hospital
Division name
Department of Diabetes and Endocrinology
Zip code
Address
1-5-1,Taijima, Minami-ku, Kumamoto-shi, Kumamoto, Japan
TEL
096-370-3111
Homepage URL
knihida@orange.ocn.ne.jp
Sponsor or person
Institute
POSEIDON Study Group
Institute
Department
Personal name
Funding Source
Organization
Public Health Research Foundation
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
熊本中央病院(熊本県)、水俣市立総合医療センター(熊本県)、熊本総合病院(熊本県)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 26 | 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
| 2013 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Items under observation
a.initiation date and completion date
b.stuation of taking sitagliptin
c.concomitant medication
d.concomitant treatment
e.history of treatment for type2 diabetes
f.clinical laboratory data
g.adverse event
h.hypoglycemia
Management information
Registered date
| 2015 | Year | 02 | Month | 26 | Day |
Last modified on
| 2018 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014559
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
