UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018949
Receipt No. R000021922
Scientific Title Comparison of efficacy of anagliptin and alogliptin for lipid profile between type 2 diabetic patients
Date of disclosure of the study information 2015/09/08
Last modified on 2017/09/10

* 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 Comparison of efficacy of anagliptin and alogliptin for lipid profile between type 2 diabetic patients
Acronym Comparison of efficacy of anagliptin and alogliptin for lipid profile
Scientific Title Comparison of efficacy of anagliptin and alogliptin for lipid profile between type 2 diabetic patients
Scientific Title:Acronym Comparison of efficacy of anagliptin and alogliptin for lipid profile
Region
Japan

Condition
Condition type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 One of pleiotropic effect of DPP-4 inhibitors is for improving lipid profile.
This study aimed to compare the effectiveness of anagliptin and alogliptin for lipid profile in Type 2 diabetes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes change of LDL-C at 24 weeks
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
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 anagliptin
subjects were allocated randomly by the envelope method to either of two treatment groups: anagliptin 200mg/day or alogliptin 25 mg/day(using DPP4 inhibitor was stopped). After 24-week oral administration of the allocated drug, we tested fasting blood samples.
Interventions/Control_2 alogliptin
alogliptin 25 mg/day(using DPP4 inhibitor was stopped). After 24-week oral administration of the allocated drug, we tested fasting blood samples.
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 Type 2 diabetes using DPP-4 inhibitors except for anagliptin and alogliptin, presented with LDL-C above 120mg/dl. Participants provided their informed consent to participate in the study.
Participants provided their informed consent to participate in the study.
Key exclusion criteria Patients using glinide and insulin therapy, those who were or may have been pregnant, and those with severe renal dysfunction (s-Cre levels: male>1.4mg/dl, female>1.2mg/dl) were excluded.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiya Tanaka
Organization University of Occupational and Environmental Health
Division name First Department of Internal Medicine, School of Medicine
Zip code
Address 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu
TEL 0936031611
Email tanaka@med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Kurozumi
Organization University of Occupational and Environmental Health
Division name First Department of Internal Medicine, School of Medicine
Zip code
Address 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu
TEL 0936031611
Homepage URL
Email akira@med.uoeh-u.ac.jp

Sponsor
Institute University of Occupational and Environmental Health, Japan, First Department of Internal Medicine, School of Medicine
Institute
Department

Funding Source
Organization Environmental Health, Japan, First Department of Internal Medicine, School of Medicine
Organization
Division
Category of Funding Organization Other
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
2015 Year 09 Month 08 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
2014 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
2015 Year 09 Month 30 Day
Date of closure to data entry
2015 Year 09 Month 30 Day
Date trial data considered complete
Date analysis concluded
2016 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2015 Year 09 Month 08 Day
Last modified on
2017 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021922

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.