UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Sitagliptin on Myocardial function in type-2 diabetic patients complicated by congestive heart failure
Acronym	Effect of Sitagliptin on Myocardial function in type-2 diabetic patients complicated by congestive heart failure
Scientific Title	Effect of Sitagliptin on Myocardial function in type-2 diabetic patients complicated by congestive heart failure
Scientific Title:Acronym	Effect of Sitagliptin on Myocardial function in type-2 diabetic patients complicated by congestive heart failure
Region	Japan

Condition
Condition	Type-2 diabitic patients with heart failure
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate how sitagliptin works on myocardial function in type-2 diabetic patients complicated by congestive heart failure
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Changes in systolic and diastolic cardiac funciton
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients who undergo poor blood sugar control despite on sufficient dose of sulfonyl urea antidiabetic drug
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with chronic heart failure (NYHA functional class II or III) who are under poor control despite receiving sulfonyl urea based antidiabetic medication for 3 months with a HbA1c of 6.5% and more
Key exclusion criteria	1) type I diabetes 2) Uncontrolled hypertension 3) patiens who experienced myocardial infarction, coronay bypass surgery, stroke, TIA within 3 months prior to the participation 4) patiens who experienced ketosis or diabetic coma for the past 6 months 5) patients with severe infectious disease, major surgery, and trauma4 6) serum creatinine level of 1.5 mg/ml and more 7) on insuline 8) on pregnancy 9) allergic to sitagliptin
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Nobukazu Middle name Last name Ishizaka
Organization	Osaka Medical College
Division name	Department of Cardiology
Zip code	569-8686
Address	2-7, Daigakumachi, Takatsuki, Osaka
TEL	072-683-1221
Email	Ishizaka@poh.osaka-med.ac.jp

Public contact
Name of contact person	1st name Takahide Middle name Last name Ito
Organization	Osaka Medical College
Division name	Department of Cardiology
Zip code	569-8686
Address	2-7, Daigakumachi, Takatsuki, Osaka
TEL	072-683-1221
Homepage URL
Email	in3016@poh.osaka-med.ac.jp

Sponsor
Institute	Department of Cardiology, Osaka Medical College
Institute
Department

Funding Source
Organization	Department of Cardiology, Osaka Medical College
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	Osaka Medical College
Address	2-7, Daigaku-machi, Takatsuki
Tel	072-683-1221
Email	in3016@osaka-med.ac.jp

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	2014 Year 01 Month 01 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	Terminated
Date of protocol fixation	2011 Year 11 Month 07 Day
Date of IRB	2014 Year 11 Month 01 Day
Anticipated trial start date	2014 Year 11 Month 01 Day
Last follow-up date	2017 Year 11 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 12 Month 04 Day
Last modified on	2021 Year 03 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014624