UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013682 |
|---|---|
| Receipt number | R000015622 |
| Scientific Title | The lipid lowering effect of anagliptin in type2 diabetes mellitus with dyslipidemia |
| Date of disclosure of the study information | 2014/04/18 |
| Last modified on | 2015/04/14 09:43:05 |
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Basic information
Public title
The lipid lowering effect of anagliptin in type2 diabetes mellitus with dyslipidemia
Acronym
The lipid lowering effect of anagliptin in type2 diabetes mellitus with dyslipidemia
Scientific Title
The lipid lowering effect of anagliptin in type2 diabetes mellitus with dyslipidemia
Scientific Title:Acronym
The lipid lowering effect of anagliptin in type2 diabetes mellitus with dyslipidemia
Region
| Japan |
Condition
Condition
Type2 diabetes mellitus patients with dyslipidemia
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect on lipid lowering effects and their mechanism of anagliptin in type 2 diabetes mellitus patients with dyslipidemia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of sitosterol, campesterol and lathosterol
Key secondary outcomes
Change of serum lipids and apolipoproteins
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
anagliptin as a suiny tablet.Taking a dose of 100 to 200 mg twice a day.
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
Type2 diabetes mellitus patients who accords the terms below.
1.Patients whose LDL-C between 100mg/dL to 160mg/dL with or without taking drugs for dyslipidemia.
2.Patients whose treatment for diabetes mellitus will not change between the trial periods.
3.Written informed consent is obtained from subjects before entry.
4.Patients who is over 20years old.
Key exclusion criteria
1.Patients who accord the contraindication of anagliptin.
2.Patients whose HbA1c over 8.0% before entry.
3.Patients who suffered coronary heart disease in past.
4.Patients whose renal function is declined (Ccr below the 30) or ongoing dialysis.
5.Individuals who are ineligible in the opinion of the physician in charge.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Kinoshita |
Organization
Teikyo university
Division name
Internal Medicine
Zip code
Address
2-11-1 Kaga, Itabashi-Ku, Tokyo 173-8606
TEL
03-3964-1211
makkino@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsunobu Kawamura |
Organization
Tokyo Teishin Hospital
Division name
Internal Medicine
Zip code
Address
2-14-23 Fujimi, Chiyoda-ku Tokyo 102-8798
TEL
03-5214-7111
Homepage URL
mk-hakodate@tth-japanpost.jp
Sponsor or person
Institute
Internal Medicine, Teikyo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2014 | Year | 04 | Month | 18 | 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
| 2014 | Year | 04 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
| 2014 | Year | 12 | Month | 20 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 20 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 10 | Day |
Last modified on
| 2015 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015622
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
