UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025284 |
|---|---|
| Receipt number | R000028991 |
| Scientific Title | The relation between HbA1c level and duration of hypoglycemia in type 2 diabetes patients treated with sulfonylureas. |
| Date of disclosure of the study information | 2017/05/01 |
| Last modified on | 2020/07/30 13:20:44 |
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Basic information
Public title
The relation between HbA1c level and duration of hypoglycemia in type 2 diabetes patients treated with sulfonylureas.
Acronym
The relation between HbA1c level and duration of hypoglycemia in type 2 diabetes patients treated with sulfonylureas
Scientific Title
The relation between HbA1c level and duration of hypoglycemia in type 2 diabetes patients treated with sulfonylureas.
Scientific Title:Acronym
The relation between HbA1c level and duration of hypoglycemia in type 2 diabetes patients treated with sulfonylureas.
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 association between hypoglycemia and glycemic control among patients taking sulfonylureas using new CGM system,Free style libre pro, which needs no calibration during 14 days wear.
Basic objectives2
Others
Basic objectives -Others
Clinical research
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between time of hypoglycemic range(min/day) and levels of HbA1c
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
sensor insertion
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetic patient
taking sulfonylureas
HbA1c < 12%
outpatient
Key exclusion criteria
treated with insulin
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yushi |
| Middle name | |
| Last name | Hirota |
Organization
Kobe University Hospital
Division name
Department of Internal Medicine, Division of Diabetes and Endocrinology
Zip code
650-0017
Address
7-5-1 Kusunoki-Cho, Kobe , Japan
TEL
81-78-382-5860
hirota@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Yushi |
| Middle name | |
| Last name | Hirota |
Organization
Kobe University Hospital
Division name
Department of Internal Medicine, Division of Diabetes and Endocrinology
Zip code
650-0017
Address
7-5-1 Kusunoki-Cho, Kobe , Japan
TEL
81-78-382-5860
Homepage URL
hirota@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Diabetes and Endocrinology,
Department of Internal Medicine,
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Diabetes and Endocrinology,
Department of Internal Medicine,
Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shinko hospital
Nishiwaki municipal hospital
Kobe Rosai Hospital
Hyogo brain and heart center
Rokko island Konan hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the institutional review boards of Kobe University Graduate School of Medicine
Address
7-5-1 Kusunoki-Cho, Kobe,Japan
Tel
81-78-382-6669
rinri@med.kobe-u.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
神戸大学医学部附属病院(兵庫県)
神鋼記念病院(兵庫県)
西脇市立西脇病院(兵庫県)
神戸労災病院(兵庫県)
兵庫県立姫路循環器病センター(兵庫県)
六甲アイランド甲南病院(兵庫県)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/full/10.1111/jdi.13132
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1111/jdi.13132
Number of participants that the trial has enrolled
300
Results
The duration of hypoglycemia with glucose values of less than 70 mg/dL was 6.8 , 2.6 , 1.8 , 1.6 , and 0.4 min/h for HbA1c levels of no more than 6.4%, 6.5 to 6.9%, 7.0 to 7.4%, 7.5 to 7.9%, and 8.0% and over, respectively, and was significantly (P less than 0.0125) longer in the HbA1c no more than 6.4%, 6.5 to 6.9%, and 7.0 to 7.4% groups than in the 8.0% and more group.
Results date posted
| 2020 | Year | 07 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
male 182 female 87, 69.0 years old, HbA1c 7.2%
Participant flow
We analyzed CGM data of patients for whom at least 7 days of recorded data were available.
Adverse events
none
Outcome measures
The primary outcome of the study was the difference in the duration of hypoglycemia between HbA1c levels of 8.0% and more and either no more than 6.4%, 6.5 to 6.9%, 7.0 to 7.4%, or 7.5 to 7.9%.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Completed
Management information
Registered date
| 2016 | Year | 12 | Month | 15 | Day |
Last modified on
| 2020 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028991
