UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective Observational study of Sitagliptin in Subjects with type 2 Diabetes and Chronic Renal Failure
Title of the study (Brief title)	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	Kenro Nishida
Organization	Kumamoto Chuo Hospital
Division name	Department of Diabetes and Endocrinology
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	Kenro Nishida
Organization	Kumamoto Chuo Hospital
Division name	Department of Diabetes and Endocrinology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000014559