UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of lipid lowering effect of anagliptin and miglitol in patients with type 2 diabetes
Acronym	Comparison of lipid lowering effect of anagliptin and miglitol
Scientific Title	Comparison of lipid lowering effect of anagliptin and miglitol in patients with type 2 diabetes
Scientific Title:Acronym	Comparison of lipid lowering effect of anagliptin and miglitol
Region	Japan

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

Objectives
Narrative objectives1	Comparison of lipid lowering effect ofanagliptin and miglitol in patients with type 2 diabtes
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Low-density lipoprotein cholesterol (LDL-C)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
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	Administration of anagliptin
Interventions/Control_2	Administration of miglitol
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with type 2 diabetes LDL-C (120mg/dL and over)
Key exclusion criteria	Patients treated with alpha glucosidase inhibitor, DPP-4 inhibitor, insulin, or glucagon like peptide-1receptor agonist. Patients with sever liver and kidney disfunction. Patients with pregnacy. Patients with history of ileus.
Target sample size	60

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Kazutaka Aoki
Organization	Yokohama City University Hospital
Division name	Department of Endocrinology and Metabolism
Zip code
Address	Fuku-ura 3-9, Kanazawa-ku, Yokohama
TEL	045-787-2639
Email	aokikazu@yokohama-cu.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Eriko Shibata
Organization	Yokohama City University
Division name	Department of Endocrinology and Metabolism
Zip code
Address	Fuku-ura 3-9, Kanazawa-ku, Yokohama
TEL	045-787-2639
Homepage URL
Email	shibatae15@gmail.com

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	Sanwa Kagaku Kenkyusho Co., Ltd.
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	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	2016 Year 03 Month 28 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	2016 Year 02 Month 09 Day
Date of IRB	2016 Year 02 Month 09 Day
Anticipated trial start date	2016 Year 03 Month 31 Day
Last follow-up date	2018 Year 11 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 03 Month 16 Day
Last modified on	2019 Year 03 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024724