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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016645
Receipt No. 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

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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
Email 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
Email knihida@orange.ocn.ne.jp

Sponsor
Institute POSEIDON Study Group
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


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