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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024367
Receipt No. R000028048
Scientific Title Evaluation of efficacy in diabetes control of basal insulin plus SGLT-2 inhibitor/GLP-1 receptor agonist/ rapid insulin in patients with type 2 diabetes
Date of disclosure of the study information 2016/10/12
Last modified on 2019/04/22

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Basic information
Public title Evaluation of efficacy in diabetes control of basal insulin plus SGLT-2 inhibitor/GLP-1 receptor agonist/ rapid insulin in patients with type 2 diabetes
Acronym Evaluation of efficacy in diabetes control of basal insulin plus SGLT-2 inhibitor/GLP-1 receptor agonist/ rapid insulin
Scientific Title Evaluation of efficacy in diabetes control of basal insulin plus SGLT-2 inhibitor/GLP-1 receptor agonist/ rapid insulin in patients with type 2 diabetes
Scientific Title:Acronym Evaluation of efficacy in diabetes control of basal insulin plus SGLT-2 inhibitor/GLP-1 receptor agonist/ rapid insulin
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy and safety of basal insulin plus SGLT-2 inhibitor/GLP-1 receptor agonist/ rapid insulin
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change in HbA1c after 52 weeks
Change in weight after 52 weeks
Key secondary outcomes Level of self-monitoring of blood glucose
Frequency of hypoglycemia
Change in amount of insulin

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Basal insulin plus SGLT-2 inhibitor(52 weeks)
Interventions/Control_2 Basal insulin plus GLP-1 receptor agonist (52 weeks)
Interventions/Control_3 Basal insulin plus rapid insulin (52 weeks)
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 1. Participants with type 2 diabetes
2. Participants who can perform self-monitoring blood glucose
3. BMI<=45 kg/m2
4. HbA1c between 7.0 to 10.5 %
Key exclusion criteria 1.Participants with severe liver dysfunction
2.Participants with severe renal dysfunction
3.Participants with severe diabetic complications
4.Participants who are pregnant, hope to be pregnant, or are in lactation period
5.Participants whose fasting serum C-peptide immunoreactivity below 0.5ng/ml
6.Participants whose postprandial serum C-peptide immunoreactivity below 0.5ng/ml
Target sample size 75

Research contact person
Name of lead principal investigator
1st name Tetsuya
Middle name
Last name Babazono
Organization Tokyo Women's Medical University Hospital
Division name Diabetes center
Zip code 1628666
Address 8-1, Kawadacho, Shinjuku-ku, Tokyo
TEL 03-3353-8111
Email babazono.dmc@twmu.ac.jp

Public contact
Name of contact person
1st name Junko
Middle name
Last name Oya
Organization Tokyo Women's Medical University Hospital
Division name Diabetes center
Zip code 1628666
Address 8-1, Kawadacho, Shinjuku-ku, Tokyo
TEL 03-3353-8111
Homepage URL
Email johya.dmc@twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor NS building Clinic
Tomonaga Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Women's Medical University Hospital
Address 8-1, Kawadacho, Shinjuku-ku, Tokyo
Tel 03-3353-8111
Email krinri.bm@twmu.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 東京女子医科大学病院(東京都)、NSビルクリニック(東京都)、ともながクリニック(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 12 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 No longer recruiting
Date of protocol fixation
2016 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 12 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
2016 Year 10 Month 11 Day
Last modified on
2019 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028048

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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