UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021494
Receipt number R000024724
Scientific Title Comparison of lipid lowering effect of anagliptin and miglitol in patients with type 2 diabetes
Date of disclosure of the study information 2016/03/28
Last modified on 2019/03/27 09:51:02

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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

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

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 or person

Institute

Yokohama City University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024724


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name