UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042895 |
|---|---|
| Receipt number | R000048963 |
| Scientific Title | Study of Glycemic Variability, Hypoglycemia Using Continuous Glucose Monitoring in Type 2 Diabetes Mellitus Changed from Basal-Bolus Therapy to Basal-GLP-1 RA Therapy |
| Date of disclosure of the study information | 2021/01/04 |
| Last modified on | 2021/01/04 13:14:47 |
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Basic information
Public title
Study of Glycemic Variability, Hypoglycemia Using Continuous Glucose Monitoring in Type 2 Diabetes Mellitus Changed from Basal-Bolus Therapy to Basal-GLP-1 RA Therapy
Acronym
Study of switching from BBT to BGT under CGM in T2DM
Scientific Title
Study of Glycemic Variability, Hypoglycemia Using Continuous Glucose Monitoring in Type 2 Diabetes Mellitus Changed from Basal-Bolus Therapy to Basal-GLP-1 RA Therapy
Scientific Title:Acronym
Study of switching from BBT to BGT under CGM in T2DM
Region
| Japan |
Condition
Condition
Type 2 Diabetes Mellitus
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is important to consider changing to drugs that are unlikely to cause hypoglycemia in patients who have stable glycemic status. At the same time, however, it should be noted that inappropriate de-escalation of treatment leads to a worsening of the glycemic situation. Thus, in patients with T2D treated with Basal-Bolus Therapy (BBT) using a small amount of bolus insulin and stable glycemic control, under CGM, we had left basal insulin and switched from all bolus insulin to a weekly GLP-1 RA.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Time Below Range and Time In Range for 3 days before and after treatment change.
Key secondary outcomes
Mean glucose levels, %CV for 3 days before and after treatment change and HbA1c, BMI immediately before and one month after the channge.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | < |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adult type2 diabetic patients/Patients with HbA1c within management goals/Patients who receive only relatively small amount of bolus insulin/Patients wearing CGM when switching treatments
Key exclusion criteria
Patients with contraindicated duraglutide
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Arina |
| Middle name | |
| Last name | Miyoshi |
Organization
Sapporo City General Hospital
Division name
Department of Diabetes and Endocrinology
Zip code
060-8604
Address
Kita 11, Nishi 13, Chuo-ku, Sapporo, Japan
TEL
011-726-2211
arina.miyoshi@doc.city.sapporo.jp
Public contact
Name of contact person
| 1st name | Arina |
| Middle name | |
| Last name | Miyoshi |
Organization
Sapporo City General Hospital
Division name
Department of Diabetes and Endocrinology
Zip code
060-8604
Address
Kita 11, Nishi 13, Chuo-ku, Sapporo, Japan
TEL
011-726-2211
Homepage URL
arina.miyoshi@doc.city.sapporo.jp
Sponsor or person
Institute
Department of Diabetes and Endocrinology,Sapporo City General Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Diabetes and Endocrinology,Sapporo City General Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hokkaido University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo City General Hospital
Address
Kita 11, Nishi 13, Chuo-ku, Sapporo, Japan
Tel
011-726-2211
arina.miyoshi@doc.city.sapporo.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
| 2021 | Year | 01 | Month | 04 | 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
25
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
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective obsevational study. We are analyzing 25 tareget patients and writing a treatise.
Management information
Registered date
| 2021 | Year | 01 | Month | 04 | Day |
Last modified on
| 2021 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048963
