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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028014
Receipt No. 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

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Basic information
Public title The study of dapagliflozin versus sitagliptin treatment efficacy on preventing cardiovascular risk factors in type 2 DM patients (DIVERSITY-CVR study)
Acronym The study of dapagliflozin versus sitagliptin treatment efficacy on preventing cardiovascular risk factors in type 2 DM patients (DIVERSITY-CVR study)
Scientific Title The study of dapagliflozin versus sitagliptin treatment efficacy on preventing cardiovascular risk factors in type 2 DM patients (DIVERSITY-CVR study)
Scientific Title:Acronym The study of dapagliflozin versus sitagliptin treatment efficacy on preventing cardiovascular risk factors in type 2 DM patients (DIVERSITY-CVR study)
Region
Japan

Condition
Condition Type 2 Diabetes Mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 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)
Key secondary outcomes 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

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 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.
Interventions/Control_2 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.
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 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

Key exclusion criteria 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
Target sample size 340

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Professor 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 Omorinishi, Ota-ku, Tokyo, 143-8540 Japan
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, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo
TEL 03-3295-1350
Homepage URL
Email takayama@soiken.com

Sponsor
Institute the Japan Society for Patient Reported Outcome (PRO)
Institute
Department

Funding Source
Organization AstraZeneca K.K.
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
2017 Year 06 Month 30 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
2017 Year 06 Month 23 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 10 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
2017 Year 06 Month 30 Day
Last modified on
2019 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032081

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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