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
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
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
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
