UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018754 |
|---|---|
| Receipt number | R000021695 |
| Scientific Title | Dapagliflozin effectiveness on the vascular endothelial function and glycemic control in T2D with moderately inadequate glycemic control |
| Date of disclosure of the study information | 2015/08/21 |
| Last modified on | 2018/11/22 11:22:33 |
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Basic information
Public title
Dapagliflozin effectiveness on the vascular endothelial function and glycemic control in T2D with moderately inadequate glycemic control
Acronym
Dapagliflozin effectiveness on the vascular endothelial function and glycemic control (DEFENCE study)
Scientific Title
Dapagliflozin effectiveness on the vascular endothelial function and glycemic control in T2D with moderately inadequate glycemic control
Scientific Title:Acronym
Dapagliflozin effectiveness on the vascular endothelial function and glycemic control (DEFENCE study)
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study attempts to reveal the positive effects of dapagliflozin on body weight, blood pressure, lipid metabolism, glycemic levels and endothelial function in Japanese T2D patients with moderately inadequate glycemic control including elderly, by using FMD and CAVI values to compare with metformin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in FMD volume from baseline to the 16-week observation point
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dapagliflozin as add-on medication group:
Patients enrolled in this group orally take dapagliflozin 5mg once per day in addition to other medications during the 16-week period.
Interventions/Control_2
Increase metformin dosage group:
Patients enrolled in this group change their metformin dose from 750mg up to 1500mg, and orally take it in 2 or 3 times per day during the 16-week period.
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
Patients who meet all of the following criteria are included in this study.
1. In addition to a diet and exercise, type 2 diabetes patients who have been treating diabetes a) for more than 12 weeks using 750mg of metformin, or b) with one type of oral hypoglycemic agents* in addition to 750mg of metformin
*In the case of SU users, glimepiride (2 mg or less than it) or glimicron (40 mg or less than it) are allowed
2. HbA1c (NGSP values) 6.0% or higher and under 8.0%
3. Males or females aged 20 to 74
4. Patients who can closely follow the medication compliance
5. Patients who can provided written consent to participate in the clinical study
Key exclusion criteria
Patients who fall into any of the following criteria are excluded from participating in the study.
1. Type 1 diabetes or secondary diabetes
2. Had used SGLT2 inhibitors, GLP-1 agonists, or insulin 12 weeks before providing their consent
3. Had used a dose of metformin exceeding 750mg per day 12 weeks before providing their consent
4. Had started taking angiotensin-converting enzyme inhibitor (ACE inhibitor), angiotensin II receptor antagonist (ARB), HMG-CoA reductase inhibitor (statin), or antiplatelet drugs, or had their medication dose changed (including reducing the dose) 12 weeks before providing their consent
5. Patients who have a severe infection, have had or are about to have surgery, or are suffering from a serious trauma
6. With a medical history of myocardial infarction, angina, stroke or cerebral infarction
7. With atrial (chronic) fibrillation, frequent supraventricular or ventricular ectopy
8. With a moderate or severe level of cardiac insufficiency (patients with class III or more as classified by the NYHA/New York Heart Association)
9. Ankle Brachial Pressure Index (ABI)< 0.9
10. Serious liver or renal functional failure (serum creatinine 1.3mg/dL or greater, or eGFR< 45mL/min/1.73 square meters)
11. Unstable blood pressure or lipid abnormalities within 12 weeks before providing their consent
12. Addicted to alcohol or drugs
13. Patients who are pregnant or breastfeeding, or who may be, or plan to be, pregnant
14. Dehydrated (abnormal test results of hematocrit and BUN values, and complaint of symptoms of dehydration)
15. Using diuretics
16. Urinary tract or genital infections within 12 weeks before providing their consent
17. With a past history of hypersensitivity to the study drug
18. At risks of ketoacidosis, diabetic coma or precoma
19. Other conditions considered to be unsuitable by the attending physician
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Prof. Takahisa Hirose |
Organization
Toho University Omori Medical Center
Division name
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address
6-11-1 Omori Nishi, Ota-ku, Tokyo
TEL
03-3762-4151
takahisa.hirose@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Takayama |
Organization
Soiken Inc.
Division name
Clinical Study Support Division
Zip code
Address
NBF Ogawamachi Building 4F, Kanda Ogawamachi 1-3-1, Chiyoda-ku, Tokyo 101-0052
TEL
03-3295-1350
Homepage URL
takayama@soiken.com
Sponsor or person
Institute
Japan Society for Patient Report Outcome
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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 08 | Month | 21 | 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
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 21 | Day |
Last modified on
| 2018 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021695
