UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038160
Receipt number R000043499
Scientific Title Effects of pemafibrate on metabolic parameters in patients with diabetes
Date of disclosure of the study information 2019/10/01
Last modified on 2023/04/03 18:48:30

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Basic information

Public title

Effects of pemafibrate on metabolic parameters in patients with diabetes

Acronym

Effects of pemafibrate on metabolic parameters in patients with diabetes

Scientific Title

Effects of pemafibrate on metabolic parameters in patients with diabetes

Scientific Title:Acronym

Effects of pemafibrate on metabolic parameters in patients with diabetes

Region

Japan


Condition

Condition

Type 2 diabetes and hypertriglyceridemia

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate effects of pemafibrate on glucose- and lipid-metabolic parameters in patients with type 2 diabetes and hypertriglyceridemia

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Measurement of serum triglyceride level every 1 month for 5 years

Key secondary outcomes

Measurement of serum levels of cholesterol, glucose, insulin, and hepatic function parameters, HbA1c level, and BMI every 1 month for 5 years


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Pemafibrate (0.1 mg b.i.d.) was administered for 5 years

Interventions/Control_2


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

90 years-old >

Gender

Male and Female

Key inclusion criteria

Patients with type 2 diabetes having hypertriglyceridemia

Key exclusion criteria

Patients having hepatic and renal dysfunction (serum levels of AST, ALT, and gamma-GTP >100 U/L and/or serum creatinine level >2.0 mg/dL)

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Masataka
Middle name
Last name Kusunoki

Organization

Nagoya University

Division name

Research Center of Health, Physical Fitness and Sports

Zip code

464-8601

Address

Furo-cho, Chikusa-ku, Nagoya

TEL

+81-52-789-3946

Email

info@tonyo.jp


Public contact

Name of contact person

1st name Masataka
Middle name
Last name Kusunoki

Organization

Nagoya University

Division name

Research Center of Health, Physical Fitness and Sports

Zip code

464-8601

Address

Furo-cho, Chikusa-ku, Nagoya

TEL

+81-52-789-3946

Homepage URL


Email

info@tonyo.jp


Sponsor or person

Institute

Akishima Clinic

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Akishima Clinic

Address

4-2-29, Sakae, Naka-ku, Nagoya

Tel

+81 52 243 1024

Email

kusu0910noki@yahoo.co.jp


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

医療法人社団織田会あきしまクリニック


Other administrative information

Date of disclosure of the study information

2019 Year 10 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

https://benthamscience.com/article/109219

Number of participants that the trial has enrolled

27

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results

2020 Year 08 Month 18 Day

Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2017 Year 07 Month 09 Day

Date of IRB

2017 Year 07 Month 09 Day

Anticipated trial start date

2018 Year 06 Month 01 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry

2025 Year 09 Month 30 Day

Date trial data considered complete

2025 Year 10 Month 31 Day

Date analysis concluded

2025 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2019 Year 09 Month 30 Day

Last modified on

2023 Year 04 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043499


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name