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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027255
Receipt No. 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

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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
Email 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
Email yajima5639@gmail.com

Sponsor
Institute Department of nephrology, Matsunami general hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031171

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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