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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017064
Receipt No. R000019790
Scientific Title Effect of Anagliptin and Sitagliptin on low-density lipoprotein cholesterol in patients with type 2 diabetes and cardiovascular risk factors: Randomized controlled trial
Date of disclosure of the study information 2015/04/08
Last modified on 2019/02/03

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Basic information
Public title Effect of Anagliptin and Sitagliptin on low-density lipoprotein cholesterol in patients with type 2 diabetes and cardiovascular risk factors: Randomized controlled trial
Acronym Randomized Evaluation of Anagliptin versus Sitagliptin On low-density lipoproteiN cholesterol in diabetes Trial
Scientific Title Effect of Anagliptin and Sitagliptin on low-density lipoprotein cholesterol in patients with type 2 diabetes and cardiovascular risk factors: Randomized controlled trial
Scientific Title:Acronym Randomized Evaluation of Anagliptin versus Sitagliptin On low-density lipoproteiN cholesterol in diabetes Trial
Region
Japan

Condition
Condition Patients with type 2 diabetes with cardiovascular risk factors who treated with diet, exercise or antidiabetic medications
Patients who were treated with statins for 8 weeks or longer
Patients with low-density lipoprotein cholesterol equal to or greater than 100 mg/dL in the at least one of three measurements after the administration of statins
Patients with glycerated hemoglobin (HbA1c, NGSP) equal to or greater than 6.0 % (7.0 % if patients were not treated with dipeptidyl-peptidase 4 inhibitors) and lesser than 10.5 %
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to determine whether Anagliptin or Sitagliptin are effective in reducing the low-density lipoprotein cholesterol in patients with type 2 diabetes and cardiovascular risk factors on statin.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in low-density lipoprotein cholesterol
Change in glycated hemoglobin
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are 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
Interventions/Control_2 Sitagliptin
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 Patients with type 2 diabetes with cardiovascular risk factors who treated with diet, exercise or antidiabetic medications
Patients who were treated with statins for 8 weeks or longer
Patients with low-density lipoprotein cholesterol equal to or greater than 100 mg/dL in the at least one of three measurements after the administration of statins
Patients with glycerated hemoglobin (HbA1c, NGSP) equal to or greater than 6.0 % (7.0 % if patients were not treated with dipeptidyl-peptidase 4 inhibitors) and lesser than 10.5 %
Key exclusion criteria 1) Patients with type 1 diabetes
2) Patients with triglyceride equal to or greater than 400 mg/dL in the previous fasting measuments
3) Patients with pregnancy, possible pregnancy, or on breast-feeding
4) Patients with severe infections, perioperative status, or severe trauma
5) Patients with elevated creatinine (>=2.4 mg/dl for men; >=2.0 mg/dl for women)
6) Patients who were received glucagon-like peptide-1receptor agonists
7) Patients whom physician in charge considered inappropriate for the study
Target sample size 300

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Shinichiro Ueda
Organization University of the Ryukyus
Division name Department of Clinical Pharmacology & Therapeutics
Zip code
Address Nishihara, Okinawa
TEL 098-895-1195
Email suedano9@dream.com

Public contact
1st name of contact person
1st name
Middle name
Last name Takeshi Morimoto
Organization Hyogo College of Medicine
Division name Department of Clinical Epidemiology
Zip code
Address 1-1 Mukogawa, Nishinomiya, Hyogo
TEL 0798-45-6879
Homepage URL
Email tm@hyo-med.ac.jp

Sponsor
Institute Institute for Clinical Effectiveness
Institute
Department

Funding Source
Organization Kowa
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
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT02330406
Org. issuing International ID_1 ClinicalTrials.gov
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 04 Month 08 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
2014 Year 12 Month 22 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 17 Day
Last follow-up date
2018 Year 01 Month 18 Day
Date of closure to data entry
2018 Year 02 Month 28 Day
Date trial data considered complete
2018 Year 03 Month 08 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 04 Month 07 Day
Last modified on
2019 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019790

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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