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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032665
Receipt No. R000037248
Scientific Title The efficacy and the utility of switching into glucagon like peptide-1 receptor agonist plus basal insulin therapy in type 2 diabetic patients treated with Basal-Bolus therapy.
Date of disclosure of the study information 2018/05/21
Last modified on 2019/05/22

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Basic information
Public title The efficacy and the utility of switching into glucagon like peptide-1 receptor agonist plus basal insulin therapy in type 2 diabetic patients treated with Basal-Bolus therapy.
Acronym The efficacy and the utility of switching from basal-bolus therapy to GLP-1 RA plus basal insulin therapy.
Scientific Title The efficacy and the utility of switching into glucagon like peptide-1 receptor agonist plus basal insulin therapy in type 2 diabetic patients treated with Basal-Bolus therapy.
Scientific Title:Acronym The efficacy and the utility of switching from basal-bolus therapy to GLP-1 RA plus basal insulin therapy.
Region
Japan

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

Objectives
Narrative objectives1 The efficacy and the utility
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the characteristics of the patient who can successfully switch the treatment
efficacy(Diabetes treatment satisfaction questionnaire: DTSQ)
Key secondary outcomes glycemic control(continuous glucose monitoring)
Urinary albumin concentration, Urinary L-FABP concentration

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Change from prandial insulins to liraglutide
Change from liraglutide to duraglutide
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
75 years-old >
Gender Male and Female
Key inclusion criteria Type 2 diabetes.
The value of HbA1c less than 7.0% with basal-bolus insulin therapy without any oral anti-diabetics.
Sum of prandial insulin dose less than 24 units
Key exclusion criteria Type 1 diabetes
with severe liver disease, severe renal disease or severe heart disease
with any carcinoma
under pregnancy
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Fumitaka
Middle name
Last name Okajima
Organization Nippon Medical School Chiba-Hokusoh Hospital
Division name Department of Endocrinology
Zip code 270-1694
Address 1715 Kamagari, Inzai, Chiba, Japan
TEL 0476-99-1111
Email okaji@nms.ac.jp

Public contact
Name of contact person
1st name Fumitaka
Middle name
Last name Okajima
Organization Nippon Medical School Chiba-Hokusoh Hospital
Division name Department of Endocrinology
Zip code 270-1694
Address 1715 Kamagari, Inzai, Chiba, Japan
TEL 0476-99-1111
Homepage URL
Email okaji@nms.ac.jp

Sponsor
Institute Department of Endocrinology, Nippon Medical School Chiba Hokusoh Hospital
Institute
Department

Funding Source
Organization Japan Society for The Promotion of Science
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Nippon Medical School Chiba-Hokusoh Hospital Institutional Review Board
Address 1715 Kamakari, Inzai, Chiba, Japan
Tel 0476-99-1111
Email meiko-hirota@nms.ac.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 05 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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 24 Day
Date of IRB
2017 Year 09 Month 15 Day
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
2019 Year 09 Month 30 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 05 Month 21 Day
Last modified on
2019 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037248

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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