UMIN-CTR Clinical Trial

Public title

Sodium glucose cotransporter inhibitor 2, Tofogliflozin versus glimepiride, comparative trial in Patients with type 2 diabetes On Body composition (STOP-OB study)

Acronym

Sodium glucose cotransporter inhibitor 2, Tofogliflozin versus glimepiride, comparative trial in Patients with type 2 diabetes On Body composition (STOP-OB study)

Scientific Title

Sodium glucose cotransporter inhibitor 2, Tofogliflozin versus glimepiride, comparative trial in Patients with type 2 diabetes On Body composition (STOP-OB study)

Scientific Title:Acronym

Sodium glucose cotransporter inhibitor 2, Tofogliflozin versus glimepiride, comparative trial in Patients with type 2 diabetes On Body composition (STOP-OB study)

Region

Japan

Condition

Type 2 Diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the effects (efficacy) of a SGLT2 inhibitor (tofogliflozin hydrate) as an add-on treatment on body weight, body fat and insulin resistance

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Change in body fat percentage from baseline to the 24th week

Key secondary outcomes

Examine the following indexes from baseline to the 24th week
1. Change in body composition other than body fat percent (fat mass, lean body mass, muscle mass, amount of body water, body water percentage, estimated bone mass, basal metabolic rate, level of basal metabolism, visceral fat level, leg muscle score, degree of obesity)

2. Change in body weight, abdominal circumstance, BMI

3. Change in indexes related to glycemic control and beta-cell function: HbA1c, blood glucose level, insulin level, C-peptide, glucagon, HOMA-beta, HOMA-R

4. Change in indexes related to lipid metabolism and arteriosclerosis: TC, HDL-C, TG, LDL-C, adiponectin, leptin

5. Indexes related to liver function: AST, ALT, gamma GTP, ketone body (total ketone, acetoacetic acid, beta hydroxybutyric acid), type IV collagen (7S), ferritin, hyaluronic acid

6. Change in indexes related to diabetic renal disease or renal function: serum creatinine, urinary albumin, eGFR

7. Change in uric acid

8. Occurrence rate of any adverse event related to the study drugs

9. Medication adherence

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Group A: Administer tofogliflozin

Patients in this tofogliflozin group orally take tofogliflozin 20 mg once a day before breakfast for 24 weeks.

Interventions/Control_2

Group B: Administer glimepiride

Patients in this glimepiride group start with glimepiride 0.5 mg, and also orally take it once a day before breakfast for 24 weeks.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

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. Patients with type 2 diabetes

2. Patients who have used a dual treatment of a DPP-4 inhibitor with metformin for 4 weeks or longer until consenting
*Those who have not changed the type of DPP-4 inhibitor or metformin as well as the dosage and administration within that time period
**The dosage of metformin must be in the range of 500 mg per day or more but no more than 1,500 mg per day

3. Patients with HbA1c 7.0% or higher, and lower than 9.0% at the time of giving their consent

4. Female and male patients at age of 20 or older, and younger than 75 years of age

5. 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. Patients with type 1 diabetes or secondary diabetes

2. Patients who have used antidiabetic medication other than DPP-4 inhibitors or metformin (e.g. insulin, GLP-1 receptor agonist) within the 12 weeks until consenting

3. Patients who have changed the dosage of a diuretic agent or started a new diuretic agent within the 12 weeks until consenting

4. Patients with BMI below 18.5 kg/m2 or BMI 35 kg/m2 or higher at the time of consenting

5. Patients with conditions contraindicated the use of study drugs

6. Patients with a medical history of hypersensitivity to the study drugs

7. Patients with moderate to severe renal function impairment, or at the terminal stage of renal failure (eGFR< 60mL/min/1.73m2)

8. Patients with severe hepatic impairment

9. Patients with a medical history of stroke or cerebral infarction

10. Patients who are currently or possibly pregnant, breastfeeding or planning to be pregnant

11. Patients with moderate to severe heart failure (New York Heart Association [NYHA] functional class III or higher)

12. Patients with urinary tract infection or genital infection

13. Patients currently with a malignancy, or with a medical history of a malignancy (excluding those who are not currently treated for the malignancy or show no redevelopment of it, or a physician assures no relapse during the study period)

14. Patients with other conditions that investigators/physicians think inappropriate to join the study

Target sample size

64

Name of lead principal investigator

1st name
Middle name
Last name	Professor Hisamitsu Ishihara

Organization

Nihon University

Division name

Division of Diabetes and Metabolic Diseases, School of Medicine

Zip code

Address

30-1 Oyaguch-Kamicho, Itabashi-ku, Tokyo

TEL

03-3972-8111

Email

ishihara.hisamitsu@nihon-u.ac.jp

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

Institute

Japan society for Patient Reported Outcome

Institute

Department

Personal name

Organization

Kowa Company, Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

02

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

01

Month

10

Day

Date of IRB

Anticipated trial start date

2017

Year

03

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

02

Month

16

Day

Last modified on

2019

Year

02

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030062