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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032125
Receipt No. R000036646
Scientific Title Comparison glycemic excursions of short-acting glucagon-like peptide 1(GLP-1) Receptor Agonists(RAs)(Liraglutide) with long-acting GLP-1 RAs(Dulaglutide).
Date of disclosure of the study information 2018/04/06
Last modified on 2019/05/21

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Basic information
Public title Comparison glycemic excursions of short-acting glucagon-like peptide 1(GLP-1) Receptor Agonists(RAs)(Liraglutide) with long-acting GLP-1 RAs(Dulaglutide).
Acronym Comparison glycemic excursions of Liraglutide with Dulaglutide.
Scientific Title Comparison glycemic excursions of short-acting glucagon-like peptide 1(GLP-1) Receptor Agonists(RAs)(Liraglutide) with long-acting GLP-1 RAs(Dulaglutide).
Scientific Title:Acronym Comparison glycemic excursions of Liraglutide with Dulaglutide.
Region
Japan

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

Objectives
Narrative objectives1 To compare the glucose-lowering effect and glycemic variability of liraglutide with these of dulaglutide using Flash Glucose monitoring (FGM) in type 2 diabetes mellitus.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Glycemic control is estimated as the mean blood glucose (MBG).
Intraday glycemic variability is assessed as the standard deviation (SD) and the mean amplitude of glycemic excursions (MAGE).
Hypoglycemia, which is defined as a sensor value of <3.9mmol/L, was also calculated as a total time at <3.9mmol/L.
Hyperglycemia, which is defined as a sensor value of >10.0mmol/L, was also calculated as a total time at >10.0mmol/L.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
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 The FGM examination is carried out at least 28 days after administering liraglutide. liraglutide is changed to dulaglutide when the first FGM examination end.
Interventions/Control_2 The FGM examination is carried out at least 28 days after administering dulaglutide. dulaglutide is changed to liraglutide when the first FGM examination end.
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 using GLP-1 RAs or the patients who judged a physician to need use of the GLP-1 RAs newly.
Key exclusion criteria Patients with abnormal aspartate aminotransferase/alanine aminotransferase elevation (3 X the upper limit of normal) were excluded from this study.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Yasuhiro
Middle name
Last name Niwa
Organization Handa City Hospital
Division name Diabetes, Metabolism and Endocrinology
Zip code 475-8599
Address 2-29, Toyocho, Handa City, Aichi
TEL 0569-22-9881
Email iriri01@goo.jp

Public contact
Name of contact person
1st name Yasuhiro
Middle name
Last name Niwa
Organization Handa City Hospital
Division name Diabetes, Metabolism and Endocrinology
Zip code 475-8599
Address 2-29, Toyocho, Handa City, Aichi
TEL 0569-22-9881
Homepage URL
Email iriri01@goo.jp

Sponsor
Institute Handa City Hospital
Institute
Department

Funding Source
Organization Handa City Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Handa City Hospital
Address 2-29, Toyocho, Handa City, Aichi
Tel 0569-22-9881
Email iriri01@goo.jp

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
2018 Year 04 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 Open public recruiting
Date of protocol fixation
2017 Year 04 Month 01 Day
Date of IRB
2017 Year 11 Month 14 Day
Anticipated trial start date
2017 Year 05 Month 01 Day
Last follow-up date
2019 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 06 Day
Last modified on
2019 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036646

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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