UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013682
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email mk-hakodate@tth-japanpost.jp

Sponsor
Institute Internal Medicine, Teikyo University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015622

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.