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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000018740
Receipt No. 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

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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
Institute Tokyo Women's Medical University
Institute
Department

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
URL(English) https://upload.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


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