UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021494 |
|---|---|
| Receipt number | R000024724 |
| Scientific Title | Comparison of lipid lowering effect of anagliptin and miglitol in patients with type 2 diabetes |
| Date of disclosure of the study information | 2016/03/28 |
| Last modified on | 2019/03/27 09:51:02 |
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Basic information
Public title
Comparison of lipid lowering effect of anagliptin and miglitol in patients with type 2 diabetes
Acronym
Comparison of lipid lowering effect of anagliptin and miglitol
Scientific Title
Comparison of lipid lowering effect of anagliptin and miglitol in patients with type 2 diabetes
Scientific Title:Acronym
Comparison of lipid lowering effect of anagliptin and miglitol
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of lipid lowering effect ofanagliptin and miglitol in patients with type 2 diabtes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Low-density lipoprotein cholesterol (LDL-C)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of anagliptin
Interventions/Control_2
Administration of miglitol
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes
LDL-C (120mg/dL and over)
Key exclusion criteria
Patients treated with alpha glucosidase inhibitor, DPP-4 inhibitor, insulin, or glucagon like peptide-1receptor agonist.
Patients with sever liver and kidney disfunction.
Patients with pregnacy.
Patients with history of ileus.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazutaka Aoki |
Organization
Yokohama City University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
Address
Fuku-ura 3-9, Kanazawa-ku, Yokohama
TEL
045-787-2639
aokikazu@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eriko Shibata |
Organization
Yokohama City University
Division name
Department of Endocrinology and Metabolism
Zip code
Address
Fuku-ura 3-9, Kanazawa-ku, Yokohama
TEL
045-787-2639
Homepage URL
shibatae15@gmail.com
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Sanwa Kagaku Kenkyusho Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2016 | Year | 03 | Month | 28 | 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
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 16 | Day |
Last modified on
| 2019 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024724
