UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012490 |
|---|---|
| Receipt number | R000014624 |
| Scientific Title | Effect of Sitagliptin on Myocardial function in type-2 diabetic patients complicated by congestive heart failure |
| Date of disclosure of the study information | 2014/01/01 |
| Last modified on | 2021/03/24 10:06:43 |
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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
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
in3016@poh.osaka-med.ac.jp
Sponsor or person
Institute
Department of Cardiology, Osaka Medical College
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014624
