UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039400
Receipt number R000044922
Scientific Title Effects of lixisenatide on gastric emptying in Japanese patients with type 2 diabetes
Date of disclosure of the study information 2020/02/05
Last modified on 2020/02/05 18:39:58

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Basic information

Public title

Effects of lixisenatide on gastric emptying in Japanese patients with type 2 diabetes

Acronym

Lixisenatide on gastric emptying

Scientific Title

Effects of lixisenatide on gastric emptying in Japanese patients with type 2 diabetes

Scientific Title:Acronym

Lixisenatide on gastric emptying

Region

Japan


Condition

Condition

T2DM

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of lixisenatide on gastric emptying using 13C acetate breath test

Basic objectives2

Pharmacodynamics

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes of the half gastric emptying time (T1/2) and the lag phase (Tlag) before and after lixisenatide treatment

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Lixisenatide therapy is initiated at 10 micro g daily, and the dose is increased to 20 micro g daily after 1 week.

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

T2DM

Key exclusion criteria

Patients who are judged by investigators to be inappropriate for inclusion in this study.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Yasushi
Middle name
Last name Tanaka

Organization

St. Marianna University School of Medicine

Division name

Division of Metabolism and Endocrinology, Department of Internal Medicine

Zip code

216-8511

Address

2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan

TEL

0449778111

Email

y2tanaka@marianna-u.ac.jp


Public contact

Name of contact person

1st name Yoshio
Middle name
Last name Nagai

Organization

St. Marianna University School of Medicine

Division name

Division of Metabolism and Endocrinology, Department of Internal Medicine

Zip code

216-8511

Address

2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan

TEL

044-977-8111

Homepage URL


Email

ynagai@marianna-u.ac.jp


Sponsor or person

Institute

St. Marianna University School of Medicine

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

St. Marianna University School of Medicine

Address

2-16-1, Sugao, Miyamae-ku, Kawasaki

Tel

0449778111

Email

k-sienbu.mail@marianna-u.ac.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



Other administrative information

Date of disclosure of the study information

2020 Year 02 Month 05 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

15

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

2014 Year 06 Month 16 Day

Date of IRB

2014 Year 07 Month 22 Day

Anticipated trial start date

2014 Year 07 Month 22 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 02 Month 05 Day

Last modified on

2020 Year 02 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044922


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name