UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004236 |
|---|---|
| Receipt number | R000005093 |
| Scientific Title | The effects of sitagliptin as a DPPIV inhibitor on vascular endothelial and autonomic nerve functions in patients with type II diabetes mellitus. |
| Date of disclosure of the study information | 2010/09/20 |
| Last modified on | 2012/09/24 08:55:33 |
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Basic information
Public title
The effects of sitagliptin as a DPPIV inhibitor on vascular endothelial and autonomic nerve functions in patients with type II diabetes mellitus.
Acronym
The effects of sitagliptin as a DPPIV inhibitor on vascular endothelial and autonomic nerve functions in patients with type II diabetes mellitus.
Scientific Title
The effects of sitagliptin as a DPPIV inhibitor on vascular endothelial and autonomic nerve functions in patients with type II diabetes mellitus.
Scientific Title:Acronym
The effects of sitagliptin as a DPPIV inhibitor on vascular endothelial and autonomic nerve functions in patients with type II diabetes mellitus.
Region
| Japan |
Condition
Condition
Type II diabetes mellitus
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effects of sitagliptin as a DPPIV inhibitor on vascular endothelial and autonomic nerve functions in patients with type II diabetes mellitus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Flow mediated dilation (FMD)
Key secondary outcomes
HbA1c, fasting blood glucose, autonomic nerve function
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
Oral sitagliptin administration (50 mg) once daily before breakfast
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age more than 20 years
2) Outpatients
3) Inadequate glucose control even after dietary and exercise therapies for more than 8 weeks
4) No previous administration of pioglitazone as an oral hypoglycemic drug
5) 6.1% more than fasting HbA1c under 10%
6) Fasting blood glucose less than 270 mg/dl
7) Patients who themselves can voluntarily provide written consent to participate in this study, and can also follow the study protocol
Key exclusion criteria
1) Type I diabetes mellitus
2) Patients receiving insulin therapy
3) Severe renal dysfunction requiring hemodialysis or peritoneal dialysis
4) Severe hepatopathy/nephropathy or heart disease that may affect the evaluation of drug safety
5) Patients who are deemed to be inappropriate by the investigator or sub-investigators
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kyoichi Mizuno |
Organization
Nippon Medical School Department of Medicine
Division name
Division of Cardiology, Hepatology,Geriatrics and Integrated Medicine
Zip code
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo Japan 113-8603
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nippon Medical School Department of Medicine
Division name
Division of Cardiology, Hepatology,Geriatrics and Integrated Medicine
Zip code
Address
TEL
03-3822-2131
Homepage URL
Sponsor or person
Institute
Nippon Medical School Department of Medicine
Division of Cardiology, Hepatology,Geriatrics and Integrated Medicine
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School Department of Medicine
Division of Cardiology, Hepatology,Geriatrics and Integrated Medicine
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
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 19 | Day |
Last modified on
| 2012 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005093
