Unique ID issued by UMIN | UMIN000028014 |
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Receipt number | R000032081 |
Scientific Title | The study of dapagliflozin versus sitagliptin treatment efficacy on preventing cardiovascular risk factors in type 2 DM patients (DIVERSITY-CVR study) |
Date of disclosure of the study information | 2017/06/30 |
Last modified on | 2019/03/04 18:25:58 |
The study of dapagliflozin versus sitagliptin treatment efficacy on preventing cardiovascular risk factors in type 2 DM patients (DIVERSITY-CVR study)
The study of dapagliflozin versus sitagliptin treatment efficacy on preventing cardiovascular risk factors in type 2 DM patients (DIVERSITY-CVR study)
The study of dapagliflozin versus sitagliptin treatment efficacy on preventing cardiovascular risk factors in type 2 DM patients (DIVERSITY-CVR study)
The study of dapagliflozin versus sitagliptin treatment efficacy on preventing cardiovascular risk factors in type 2 DM patients (DIVERSITY-CVR study)
Japan |
Type 2 Diabetes Mellitus
Endocrinology and Metabolism |
Others
NO
From the perspective of preventing complications of T2DM patients, the purpose of this study is to compare the efficacy of dapagliflozin and sitagliptin in terms of avoiding risk factors for CVD.
Efficacy
Ratio of achieving a composite endpoint of the following 3 items from baseline to the 24th week
1. HbA1c below 7%
2. Body weight loss of 3%
3. Avoidance of hypoglycemia (Level 2)
1. Ratio of achieving HbA1c below 7%
2. Ratio of achieving body weight loss of 3%
3. Change in HbA1c
4. Circadian change of blood glucose
5. Day-to-day variability of blood glucose
6. Change in fasting blood glucose
7. Change in body weight and BMI
8. Change in lipid metabolism marker (HDL-chol, T-chol, LDL-chol, TG)
9. Change in eGFR
10. Values from the general blood test (blood cell count, Na, K, Cl, uric acid, serum creatinine, AST, ALT, BUN, IRI, HOMA-R)
11. Ratio of avoiding hypoglycemia (Level 2) [achievement rate]
12. Frequency and onset time of hypoglycemia (Level 1)
13. Frequency and onset time of hypoglycemia (Level 2)
14. Frequency of experiencing hypoglycemia (Level 3)
15. Medication adherence rate
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
2
Treatment
Medicine |
Group A: Administer Dapagliflozin
In principle, dapagliflozin is orally taken once a day after breakfast.
Patients in the empagliflozin group start with dapagliflozin 5mg per day and in principle it is increased to 10mg per day if HbA1c is 7% or higher after their observation point of 8th week.
Group B: Administer sitagliptin
In principle, sitagliptin is orally taken once a day after breakfast.
Patients start with sitagliptin 50mg per day and in principle it is
increased to 100mg per day if HbA1c is 7% or higher after their
observation point of 8th week.
20 | years-old | <= |
80 | years-old | > |
Male and Female
Patients who meet all of the following criteria are included in this study:
1. Male and female patients who are at age of 20 years or older and younger than 80 years when giving their consent
2. Patients with type 2 diabetes
3. Patients who have not used any antidiabetic medication within 8 weeks before consenting, or those who have only used beguanide
4. Patients with HbA1c 7.1% or higher but no more than 10.0% within 12 weeks before consenting
5. Patients with BMI 23kg/m2 or higher
6. Patients who can give their consent in a written form
Patients who fall into any of the following criteria are excluded from participating in the study:
1. Type 1 diabetes mellitus or secondary diabetes
2. Patients with a medical history of diabetic ketoacidosis
3. Patients who had myocardial infarction, cerebral infarction, or stroke within 12 weeks before giving their consent
4. Patients with severe liver disease (Patients with AST or ALT value five times or more of the upper limit of the stand value in each research institution)
5. Patients with renal disease (serum creatinine 1.3 mg/dL or higher, or eGFR less than 45 mL/min/1.73m2)
6. Patients seemingly with unstable hypertension or dyslipidemia within 12 weeks before consenting
7. Patients with addiction of either alcohol or drugs
8. Patients are currently pregnant, possibly pregnant, breast-feeding, or planning to be pregnant during the study
9. Dehydrated patients (test results show abnormality in hematocrit or BUN, or patients complain to have a symptom of dehydration)
10. Patients with urinary tract infection or genital infection with 12 weeks before consenting
11. Contraindication: patients with hypersensitivity to any medical component of each study drug
12. Contraindication: patients with severe ketoacidosis, diabetic coma or precoma
13. Contraindication: patients during a perioperative period, or with severe infection or physical injury
14. Patients with other conditions that the investigator/researcher thinks inappropriate for the study
340
1st name | |
Middle name | |
Last name | Professor Takahisa Hirose |
Toho University Omori Medical Center
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine,
6-11-1 Omorinishi, Ota-ku, Tokyo, 143-8540 Japan
03-3762-4151
takahisa.hirose@med.toho-u.ac.jp
1st name | |
Middle name | |
Last name | Hiroki Takayama |
Soiken Inc.
Clinical Study Support Division
NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo
03-3295-1350
takayama@soiken.com
the Japan Society for Patient Reported Outcome (PRO)
AstraZeneca K.K.
Profit organization
NO
2017 | Year | 06 | Month | 30 | Day |
Unpublished
Completed
2017 | Year | 06 | Month | 23 | Day |
2017 | Year | 07 | Month | 10 | Day |
2017 | Year | 06 | Month | 30 | Day |
2019 | Year | 03 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032081
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