UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019457 |
|---|---|
| Receipt number | R000022501 |
| Scientific Title | Effects of Dapagliflozin on 24-h Glycemic Changes in Japanese Patients with type 2 Diabetes Mellitus (T2DM), who Receives Basal supported Oral Therapy |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2023/10/30 16:07:11 |
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Basic information
Public title
Effects of Dapagliflozin on 24-h Glycemic Changes in Japanese Patients with type 2 Diabetes Mellitus (T2DM), who Receives Basal supported Oral Therapy
Acronym
DBOT
Scientific Title
Effects of Dapagliflozin on 24-h Glycemic Changes in Japanese Patients with type 2 Diabetes Mellitus (T2DM), who Receives Basal supported Oral Therapy
Scientific Title:Acronym
DBOT
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus (T2DM)
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study whether add-on of dapagliflozin on basal insulin therapy improves mean daily blood glucose levels, measured by CGM, in patietns with type 2 diabetes mellitus
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in mean daily blood glucose level before (at Day 1-2) and after (at Day 3-4) add-on or no add-on of dapagliflozin
Key secondary outcomes
Day 3-4
Change in fluctuation of 24-h blood glucose level, mean amplitude of glucose excursion, the percentage of time with glucose level >=180 mg/dL, >=70 to <180 mg/dL and <70 mg/dL from baseline
Week 4
Change in HbA1c, body composition, TG, HDL-C, LDL-C, chylomicron, VLDL, MDA-LDL, adiponectin, high-sensitive CRP, 8-isoprostane, blood pressure, body weight, BMI from baseline
Week 12
Change in the SD, mean and fluctuation of 24-h blood glucose level, mean amplitude of glucose excursion, the percentage of time with glucose level >=180mg/dL, >=70 to <180 mg/dL and <70 mg/dL, HbA1c, body composition, TG, HDL-C, LDL-C, chylomicron, VLDL, MDA-LDL, adiponectin, high-sensitive CRP, 8-isoprostane, blood pressure, body weight, BMI from baseline, Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Not to add dapagliflozin
Interventions/Control_2
To add add dapagliflozin
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Age; 20 =< and <80
2. Type 2 diabetic patients receiving basal insulin therapy
3. Outpatients or inpatients
4. HbA1c; 7.0% =< and >= 10%
5. eGFR; 45mL/min/1.73m2 =<
6. Patient understands the purpose and procedures of the study, plus voluntarily agrees to participate in the study by giving written consent prior to study participation
Key exclusion criteria
1. Type 1 diabetes mellitus, secondary diabetes mellitus
2.
3. Patients who have complications of severe hepatic disease , severe renal disease or receiving dialysis or recent 5 years malignancies. Patients with cardiovascular diseases (recent cardiovascular events, congestive heart failure, patients with uncontrolled high blood pressure)
4. Volume depleted patients (the study intends to enroll elderly patients over 65 who are more prone to volume depletion due to co-existing conditions and concomitant medications such as loop diuretics)
5. Patients with pregnancy, possible pregnancy, or on breast-feeding
6. Contraindication for the use of dapagliflozin
7. Patients who were received other sodium glucose cotransporter 2 inhibitor
8. Disqualified from the study by the primary investigator or a sub-investigator for any reason other than given above.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masataka |
| Middle name | |
| Last name | Sata |
Organization
Institute of Biomedical Sciences, Tokushima University Graduate School
Division name
Department of Cardiovascular Medicine,
Zip code
770-8503
Address
3-18-15 Kuramoto, Tokushima 770-8503, Japan
TEL
088-633-7859
masataka.sata@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Michio |
| Middle name | |
| Last name | Shimabukuro |
Organization
Fukushima Medical University
Division name
Department of Diabetes, Endocrinology and Metabolism School of Medicine
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima City, Fukushima 960-1295, Japan
TEL
024-547-1111
Homepage URL
mshimabukuro-ur@umin.ac.jp
Sponsor or person
Institute
Tokushima University Graduate School
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca K.K.
ONO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Diabetes, Endocrinology, and Metabolism, Fukushima Medical University School of Medicine
Address
1 Hikarigaoka, Fukushima City, Fukushima 960-1295, Japan
Tel
024-547-1305
mshimabukuro-ur@umin.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
徳島大学病院、社会医療法人 友愛会 豊見城中央病院 糖尿病・生活習慣病センター、医療法人 おもと会 大浜第一病院、医療法人翔南会 翔南病院、福島県立医科大学
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/37028805/
Publication of results
Unpublished
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/37028805/
Number of participants that the trial has enrolled
36
Results
https://pubmed.ncbi.nlm.nih.gov/37028805/
Results date posted
| 2023 | Year | 10 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
https://pubmed.ncbi.nlm.nih.gov/37028805/
Participant flow
https://pubmed.ncbi.nlm.nih.gov/37028805/
Adverse events
https://pubmed.ncbi.nlm.nih.gov/37028805/
Outcome measures
https://pubmed.ncbi.nlm.nih.gov/37028805/
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 22 | Day |
Last modified on
| 2023 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022501
