UMIN-CTR Clinical Trial

Public title

Study to evaluate release of glucose toxicity associated with SGLT2 inhibitors administered in patients with metabolic syndrome in type 2 diabetes

Acronym

Study to evaluate release of glucose toxicity associated with SGLT2 inhibitors administered in patients with metabolic syndrome in type 2 diabetes

Scientific Title

Study to evaluate release of glucose toxicity associated with SGLT2 inhibitors administered in patients with metabolic syndrome in type 2 diabetes

Scientific Title:Acronym

Study to evaluate release of glucose toxicity associated with SGLT2 inhibitors administered in patients with metabolic syndrome in type 2 diabetes

Region

Japan

Condition

Type 2 diabetes

Classification by specialty

Medicine in general

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To clarify the effect of SGLT2 inhibitors on glucose toxicity in patients with metabolic syndrome in type 2 diabetes

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1.Blood glucose-related: HbA1c, fasting glucose, glucagon
2.Insulin secretion-related: fasting insulin, plasma glucose after glucose tolerance test, fasting blood CPR, CPI
3.Insulin resistance: Matsuda Index
4.Metabolic syndrome-related: Abdominal circumference, neutral fat, HDL cholesterol, blood pressure
5.Oxidative stress-related: high-sensitivity CRP, adiponectin

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

SGLT2 inhibitors

Interventions/Control_2

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

Not applicable

Gender

Male and Female

Key inclusion criteria

(1)Patients with type 2 diabetes
(2)Patients satisfied with the criteria of metabolic syndrome
(3)Patients aged >= 20 years
(4)Patients who have competence to understand the study and agree with the written informed consent
(5)Patients who have not taken SGLT2 inhibitors in the last 4 weeks until the second visit

Key exclusion criteria

(1)Patients with type 1 diabetes
(2)Patients with a history of severe ketosis, diabetic coma, or diabetic pre-coma within 6 months prior to the start of study
(3)Patients with severe infection or serious trauma, or in a pre- or post-operative phase
(4)Patients with a history of hypersensitivity to the components of the study drug
(5)Patients with severe renal dysfunction (eGFR <30 mL/min/1.73 m2) or end-stage renal failure undergoing dialysis
(6)Patients with serious hepatic dysfunction
(7)Pregnant or lactating women, or those expecting to become pregnant during the study period
(8)Patients judged inadequate to enroll in the study at the discretion of principal investigator or subinvestigator

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Yoshimitsu Yamasaki

Organization

Medical Corporation KYOSOKAI AMC Nishi Umeda Clinic

Division name

Internal Medicine

Zip code

Address

Maruito Nishi-Umeda Bid 3F, 3-3-45, Umeda, Kita-ku, Osaka, 5630-0001, Japan

TEL

06-4797-5660

Email

yamasaki@amc-clinic.jp

Name of contact person

1st name
Middle name
Last name	Clinical

Organization

Bell Medical Solutions Inc.

Division name

Clinical Research and Development

Zip code

Address

1-3-7, Shiromi, Chuo-ku, Osaka 540-6313, Japan

TEL

06-6920-7589

Homepage URL

Email

nakano.satomi@bell-medical.co.jp

Institute

Medical Corporation KYOSOKAI AMC Nishi Umeda Clinic

Institute

Department

Personal name

Organization

Taisho toyama pharmaceutical Co., 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

2015

Year

11

Month

06

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

2015

Year

10

Month

16

Day

Date of IRB

Anticipated trial start date

2015

Year

11

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

2015

Year

11

Month

06

Day

Last modified on

2017

Year

11

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022388