UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024367 |
|---|---|
| Receipt number | 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 | 2021/04/17 12:11:52 |
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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
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
johya.dmc@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University Hospital
Institute
Department
Personal name
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
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
15
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
Terminated
Date of protocol fixation
| 2016 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2021 | Year | 04 | Month | 17 | Day |
Date analysis concluded
| 2021 | Year | 04 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 11 | Day |
Last modified on
| 2021 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028048
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/04/17 | 計画書160822.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2021/04/17 | 計画書160822.doc |
| Research case data | |
|---|---|
| Registered date | File name |
| 2021/04/17 | 計画書160822.doc |
Single case data URL
Value
https://center6.umin.ac.jp/ice/28048
