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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018754
Receipt No. 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

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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
Email 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
Email takayama@soiken.com

Sponsor
Institute Japan Society for Patient Report Outcome
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021695

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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