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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034353
Receipt No. R000032505
Scientific Title Effect of dulaglutide versus liraglutide on glucose variability and oxidative stress and endothelial function in type 2 diabetes patients
Date of disclosure of the study information 2018/10/10
Last modified on 2018/10/25

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Basic information
Public title Effect of dulaglutide versus liraglutide on glucose variability and oxidative stress and endothelial function in type 2 diabetes patients
Acronym Effect of dulaglutide versus liraglutide on glucose variability and oxidative stress and endothelial function in type 2 diabetes patients
Scientific Title Effect of dulaglutide versus liraglutide on glucose variability and oxidative stress and endothelial function in type 2 diabetes patients
Scientific Title:Acronym Effect of dulaglutide versus liraglutide on glucose variability and oxidative stress and endothelial function in type 2 diabetes patients
Region
Japan

Condition
Condition Type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 we aimed to investigate the effects of from once-weekly dulaglutide to once-daily liraglutide for 24 weeks on oxidative stress, endothelial function
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)oxidative stress
2)vascular endothelial function
Key secondary outcomes 1)glucose variability
2)DTSQ and eating behavior
3)Fasting plasma glucose,HbA1c
4)TG,HDL-C,LDL-C
5)Systolic and diastolic blood pressure
6)weight

Base
Study type Interventional

Study design
Basic design Parallel
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 Dulaglutide
Interventions/Control_2 liragulitide
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 1)a diagnosis of type 2 diabetes mellitus
2)20 years and over
3)HbA1c 6.5% or more
4)treatment with liraglutide for 12weeks or longer
Key exclusion criteria 1)the use of steroids or anti-inflammatory drugs,
2)diabetic ketosis and coma within 3 months before the study,
3)severe infection, severe trauma, pre-and post-operation,
4)an estimated glomerular filtration rate are within 30mL/min/1.73m2,
5)severe liver dysfunction,
6)malignancy,
7)pregnancy
8)Patients who are judged as inappropriate for inclusion by phsicians
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Ohara
Organization Showa University School of Medicine
Division name Division of Diabetes and Endocrinology, Department of Internal Medicine
Zip code
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL 03-3784-8000
Email s6018@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Ohara
Organization Showa University School of Medicine
Division name Division of Diabetes and Endocrinology, Department of Internal Medicine
Zip code
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL 03-3784-8000
Homepage URL
Email s6018@nms.ac.jp

Sponsor
Institute Showa University School of Medicine, Division of Diabetes and Endocrinology, Department of Internal Medicine
Institute
Department

Funding Source
Organization Showa University School of Medicine, Division of Diabetes and Endocrinology, Department of Internal Medicine
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 昭和大学病院

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 10 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 Completed
Date of protocol fixation
2016 Year 11 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2018 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2018 Year 10 Month 01 Day
Last modified on
2018 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032505

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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