UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027255 |
|---|---|
| Receipt number | R000031171 |
| Scientific Title | Efficacy and safety of dulaglutide in the treatment of type 2 diabetes |
| Date of disclosure of the study information | 2017/05/06 |
| Last modified on | 2017/05/06 11:02:10 |
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Basic information
Public title
Efficacy and safety of dulaglutide in the treatment of type 2 diabetes
Acronym
Efficacy and safety of dulaglutide in the treatment of type 2 diabetes
Scientific Title
Efficacy and safety of dulaglutide in the treatment of type 2 diabetes
Scientific Title:Acronym
Efficacy and safety of dulaglutide in the treatment of type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus patients
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the changes of body composition in type 2 diabetes mellitus patients treated with dulaglutide.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body composition (body fat percentage, fat mass, muscle mass, etc.) in the body composition analyzer (MLT - 50) on 3 months and 6 months after the administration of dulaglutide.
Key secondary outcomes
Changes of HbA1c, GA, body weight before and after the administration of dulaglutide.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dulaglutide 0.75mg/week, 6 months
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes whose HbA1c levels more than 7.0% (patients with advanced renal failure, GA levels more than 20%).
Key exclusion criteria
Patients with gastrointestinal bleeding, malignant tumor, liver cirrhosis, and thyroid function abnormalities.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Yajima |
Organization
Matsunami general hospital
Division name
Department of Nephrology
Zip code
Address
185-1, dendai, Kasamatsu-chou, Hashima-gun, Gifu
TEL
058-388-0111
yajima5639@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Yajima |
Organization
Matsunami general hospital
Division name
Department of Nephrology
Zip code
Address
185-1, dendai, Kasamatsu-chou, Hashima-gun, Gifu
TEL
058-388-0111
Homepage URL
yajima5639@gmail.com
Sponsor or person
Institute
Department of nephrology, Matsunami general hospital
Institute
Department
Personal name
Funding Source
Organization
Matsunami general hospital
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
| 2017 | Year | 05 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 05 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 06 | 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
| 2017 | Year | 05 | Month | 06 | Day |
Last modified on
| 2017 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031171
