UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022885
Receipt number R000026377
Scientific Title Comparison of efficacy of Teneligliptin and Sitagliptin for glucose fluctuation in Type 2 diabetes
Date of disclosure of the study information 2016/06/25
Last modified on 2018/06/27 13:08:15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Comparison of efficacy of Teneligliptin and Sitagliptin for glucose fluctuation in Type 2 diabetes

Acronym

Comparison of efficacy of Teneligliptin and Sitagliptin

Scientific Title

Comparison of efficacy of Teneligliptin and Sitagliptin for glucose fluctuation in Type 2 diabetes

Scientific Title:Acronym

Comparison of efficacy of Teneligliptin and Sitagliptin

Region

Japan


Condition

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aimed to compare the effectiveness of Teneligliptin and Sitagliptin for glucose fluctuation by using CGM.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Maximum glucose level after supper

Key secondary outcomes

AUC over 140 mg/dl after supper 18-24, AUC over 140 mg/dl after supper 20-24, GLP-1 level at 30 minutes after load, IRI level at 2h after load


Base

Study type

Interventional


Study design

Basic design

Cross-over

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

Teneligliptin 20mg/day for 1 week

Interventions/Control_2

Sitagliptin 50mg/day for 1 week

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

Type 2 diabtes ovet 20 years who provided their informed consent to participate in the study.

Key exclusion criteria

Patients using oral diabetic therapy or insulin therapy, those with mild renal dysfunction (male:s-Cre>1.5, female:s-Cre>1.3), those with severe infectin, those with severe trauma and those with severe liver dysfunction (AST and ALT: 3 times the normal levels) were excluded.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiya Tanaka

Organization

University of Occupational and Environmental Health

Division name

First Department of Internal Medicine, School of Medicine

Zip code


Address

1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu

TEL

093-603-1611

Email

tanaka@med.uoeh-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akira Kurozumi

Organization

University of Occupational and Environmental Health

Division name

First Department of Internal Medicine, School of Medicine

Zip code


Address

1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu

TEL

093-603-1611

Homepage URL


Email

akira@med.uoeh-u.ac.jp


Sponsor or person

Institute

University of Occupational and Environmental Health, Japan, First Department of Internal Medicine, School of Medicine

Institute

Department

Personal name



Funding Source

Organization

University of Occupational and Environmental Health, Japan, First Department of Internal Medicine, School of Medicine

Organization

Division

Category of Funding Organization

Other

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 06 Month 25 Day


Related information

URL releasing protocol


Publication of results

Published


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

2013 Year 09 Month 30 Day

Date of IRB


Anticipated trial start date

2013 Year 10 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 06 Month 25 Day

Last modified on

2018 Year 06 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026377


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name