UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028014
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

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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 or person

Institute

the Japan Society for Patient Reported Outcome (PRO)

Institute

Department

Personal name



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

Value
https://center6.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