UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010451 |
|---|---|
| Receipt number | R000011732 |
| Scientific Title | Clinical study on the effects of vildagliptin on glucose and lipid profiles in patients type 2 diabetes mellitus |
| Date of disclosure of the study information | 2013/04/11 |
| Last modified on | 2017/10/12 10:15:04 |
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Basic information
Public title
Clinical study on the effects of vildagliptin on glucose and lipid profiles in patients type 2 diabetes mellitus
Acronym
Clinical study on the effects of vildagliptin on glucose and lipid profiles in patients type 2 diabetes mellitus
Scientific Title
Clinical study on the effects of vildagliptin on glucose and lipid profiles in patients type 2 diabetes mellitus
Scientific Title:Acronym
Clinical study on the effects of vildagliptin on glucose and lipid profiles in patients type 2 diabetes mellitus
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is,by using vlidagliptin in type 2 diabetes mellitus ,to clarify its effect of glucose reduction and to investigate the possibility of vildagliptin for taking new place of other oral antidiabetic drugs. In addition,the effect of lipid profile is to be validated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c
Key secondary outcomes
blood glucose
lipid profile
blood pressure
weight
blood coagulation
inflammatory marker
Urinary albumin-to-creatinine ratio (UACR)
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 vildagliptin administration (50mg)twice daily.
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)patients informed and fully understood the explanation of the study.
2)outpatients age over 20 years in type 2 diabetes melliitus
3)patients in type 2 diabetes inadequate glucose control even after dietary and exercise therapies.
4)paients in type 2 diabetes taking a oral antidiabetic drug(OAD) or taking two OADs including one sulfonylurea.
Key exclusion criteria
1)patients with hypersensitivity to targeted medication
2)type 1 diabetes, diabetic ketoacidosis or diabetic coma
3)patients with severe liver dysfunaction
4)patients with severe infection or traumatic injury
5)pregnat, female with possiboility of pregnancy and breast-feeding
6)patients with severe complications
7)any other factors that may disqualify patients
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigemasa Tani |
Organization
Surugadai Nihon University Hospital
Division name
Department of Cardiology
Zip code
Address
1-8-13 Kanda-Surugadai, Chiyoda-ku, Tokyo , Japan
TEL
+81-3-3293-1711
tanishigem@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigemasa Tani |
Organization
Surugadai Nihon University Hospital
Division name
Department of Cardiology
Zip code
Address
1-8-13 Kanda-Surugadai, Chiyoda-ku, Tokyo , Japan
TEL
+81-3-3293-1711
Homepage URL
tanishigem@yahoo.co.jp
Sponsor or person
Institute
Department of Cardiology
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
駿河台日本大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 11 | 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
| 2011 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 09 | Day |
Last modified on
| 2017 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011732
