UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018740
Receipt number R000021674
Scientific Title Effects of exenatide extended-release in patients with type 2 diabetes mellitus
Date of disclosure of the study information 2015/08/21
Last modified on 2017/07/24 16:59:08

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Basic information

Public title

Effects of exenatide extended-release in patients with type 2 diabetes mellitus

Acronym

Effects of exenatidein patients with type 2 diabetes mellitus

Scientific Title

Effects of exenatide extended-release in patients with type 2 diabetes mellitus

Scientific Title:Acronym

Effects of exenatidein patients with type 2 diabetes mellitus

Region

Japan


Condition

Condition

type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare effects of exenatide and sitagliptine on blood pressure parameters in patients with type 2 diabetes mellitus.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The following outcomes are estimated 24 weeks after start of treatment:
- Changes in blood pressure by ambulatory blood pressure monitoring
- Changes in office blood pressure
- Ratios of patients requiring changes in doses or contents of medications

Key secondary outcomes

Changes in the following factors are estimated 24 weeks after start of treatment:
- fasting blood sugar and HbA1c
- inflammation: hsCRP
- renal function: urinary protein/creatinine ratio, urinary albumin/creatinine ratio, and eGFR
- renin-angiotensin system
Blood: plasma renin activity, aldosterone, prorenin, and soluble (pro)renin receptor. Urine: prorenin, soluble (pro)renin receptor, and angiotensinogen
- body weight, waist circumference, visceral fat area, and hANP
- endothelial function: flow-mediated dilation
- arterial stiffness: baPWV


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Cluster

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

weekly subcutaneously injection of
2 mg exenatide extended-release for 24 weeks

Interventions/Control_2

oral administration of 50 mg of sitagliptin once daily for 24 weeks

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

- patients with type 2 diabetes mellitus
- normotensive patients or well-controlled hypertensive patients

Key exclusion criteria

- patients contraindicated to the study drugs
- patients treated with insulin
- patients with uncontrollable hypertension
- pregnant women or women who are possibly pregnant

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Atsuhiro Ichihara

Organization

Tokyo Women's Medical University

Division name

Department of Medicine II

Zip code


Address

8-1 Kawada-cho, Shinjyuku-ku, Tokyo

TEL

03-3353-8111

Email

atzichi@endm.twmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Satoshi Morimoto

Organization

Tokyo Women's Medical University

Division name

Department of Medicine II

Zip code


Address

8-1 Kawada-cho, Shinjyuku-ku, Tokyo

TEL

03-3353-8111

Homepage URL


Email

smorimoto@endm.twmu.ac.jp


Sponsor or person

Institute

Tokyo Women's Medical University

Institute

Department

Personal name



Funding Source

Organization

Tokyo Women's Medical University

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


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

2015 Year 08 Month 21 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

Terminated

Date of protocol fixation

2015 Year 08 Month 21 Day

Date of IRB


Anticipated trial start date

2015 Year 08 Month 21 Day

Last follow-up date

2017 Year 07 Month 24 Day

Date of closure to data entry

2017 Year 07 Month 24 Day

Date trial data considered complete

2017 Year 07 Month 24 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 08 Month 20 Day

Last modified on

2017 Year 07 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021674


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name