UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Anagliptin and Sitagliptin on low-density lipoprotein cholesterol in patients with type 2 diabetes and cardiovascular risk factors: Randomized controlled trial
Title of the study (Brief title)	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
Name of lead principal investigator	Shinichiro Ueda
Organization	University of the Ryukyus
Division name	Department of Clinical Pharmacology & Therapeutics
Address	Nishihara, Okinawa
TEL	098-895-1195
Email	suedano9@dream.com

Public contact
Name of contact person	Takeshi Morimoto
Organization	Hyogo College of Medicine
Division name	Department of Clinical Epidemiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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