UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021954 |
|---|---|
| Receipt number | R000025314 |
| Scientific Title | Examination of the efficacy of dapagliflozin in patients with type 2 diabetes |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2022/10/28 11:09:08 |
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Basic information
Public title
Examination of the efficacy of dapagliflozin in patients with type 2 diabetes
Acronym
Efficacy of dapagliflozin
Scientific Title
Examination of the efficacy of dapagliflozin in patients with type 2 diabetes
Scientific Title:Acronym
Efficacy of dapagliflozin
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We add dapagliflozin and evaluate blood glucose improvement effect.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Fasting plasma glucose and HbA1c after administration 1, 3, 6, 9, 12, 18, 24, 36 months later, every 12 months thereafter if possible.
Key secondary outcomes
Change of body weight, blood pressure, kidney and liver function, lipid profile, and blood dapagliflozin concentrations after administration 1, 3, 6, 9, 12, 18, 24, 36 months later, every 12 months thereafter if possible. Blood dapagliflozin concentrations is measured until 36 months. Adverse event. Kidney function is urinary albumin, L-FABP and eGFR etc.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
We give dapagliflozin 5mg/day after an agreement for 36 months, extend if possible.
Evaluate;before and 1, 3, 6, 9, 12, 18, 24, 36 months later, every 12 months thereafter if possible
Observation period;From May1,2016 to reach planned number of cases
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes
BMI 23kg/m2<=
eGFR30ml/min/1.73m2<=
Key exclusion criteria
1.Patients with hypersensitivity to an ingredient of dapagliflozin
2.Diabetic ketoacidosis
3.Past history of coma or severe hypoglycemia
4.Severe infection or serious trauma
5.Severe liver injury, renal failure, cardiac disease, proliferative retinopathy
6.Past history of cerebral infarction
7.Past history of malignant tumor
8.Women with during pregnancy, nursing, or pregnant likelihood
9.Inadequate patients judged by doctor
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Hayakawa |
Organization
Tonami general hospital
Division name
Department of diabetes mellitus and endocrinology
Zip code
939-1395
Address
1-61 Shintomi-cho, Tonami, Toyama, 939-1395, Japan
TEL
0763-32-3320
thayakawa-endo@umin.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuo |
| Middle name | |
| Last name | Hayakawa |
Organization
Tonami general hospital
Division name
Department of diabetes mellitus and endocrinology
Zip code
939-1395
Address
1-61 Shintomi-cho, Tonami, Toyama, 939-1395, Japan
TEL
0763-32-3320
Homepage URL
thayakawa-endo@umin.ac.jp
Sponsor or person
Institute
Tonami general hospital
Department of diabetes mellitus and endocrinology
Institute
Department
Personal name
Funding Source
Organization
Tonami general hospital
Department of diabetes mellitus and endocrinology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
none
Other related organizations
Co-sponsor
Department of pharmacokinetics, Kyoto pharmaceutical university
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tonami general hospital
Address
1-61 Shintomi-cho, Tonami, Toyama, 939-1395, Japan
Tel
0763-32-3320
thayakawa-endo@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
市立砺波総合病院（富山県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 02 | Month | 23 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 17 | Day |
Last modified on
| 2022 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025314
