UMIN-CTR Clinical Trial

Public title

Study for the effect of blood glucose and metabolic risk factors
by switching Sulfonylurea to SGLT2 inhibitor in patients with type 2 diabetes.
-prospective observational study-

Acronym

Switching Sulfonylurea to SGLT2 inhibitor in patients with type 2 diabetes

Scientific Title

Study for the effect of blood glucose and metabolic risk factors
by switching Sulfonylurea to SGLT2 inhibitor in patients with type 2 diabetes.
-prospective observational study-

Scientific Title:Acronym

Switching Sulfonylurea to SGLT2 inhibitor in patients with type 2 diabetes

Region

Japan

Condition

Type 2 diabetes mellitus

Classification by specialty

Medicine in general

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Assess the effectiveness of
Ipragliflozine on glucose metabolism, frequency of hypoglycemia, body weight, lipid metabolism, blood pressure, and liver function of in patients with type 2 diabetes treating with sulfonylurea

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV

Primary outcomes

Frequency of hypoglycemia and glycemic control

Key secondary outcomes

Weight, BMI, Waist, Lipid metabolism, Blood pressure,Liver function, Complete blood count, renal function, electrolyte
Dose and period of Sulfonylurea before clinical trial, Dose change of Sulfonylurea, Change of insulin dose
(only patients using insulin)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

75

years-old

>

Gender

Male and Female

Key inclusion criteria

1)Patients with type 2 diabetes who have been taking Sulfonylurea, Glimepride(>=1 mg),Gliclazide (>=40 mg), Glibenclamide (>=1.25 mg) for more than 12 weeks, and are starting Ipragliflozine.
2)20 to 75 years old
3)BMI>=22 kg/m2
4)eGFR>=45 ml/min/1.73 m2
5)HbA1c 6.5 to 8.5 %
6)Written informed consent

Key exclusion criteria

1)Hypersensitivity to Ipragliflozine
2)Uncontrolled diabetic retinopathy
3)Severe liver dysfunction,renal dysfunction,or heart failure
4)Pregnancy,nursing woman or possibly pregnant woman
5)Severe diabetic ketosis,diabetic coma
6)Severe infection,pre and post operation,severe trauma
7)Deficiency of insulin secretion (fasting CPR <0.5 ng/ml)
8) Patients who are inadequate to enter this study due to uncontrolled diet therapy or the other reasons by physician's judgments

Target sample size

200

Name of lead principal investigator

1st name
Middle name
Last name	Hideaki Miyoshi

Organization

Hokkaido University Hospital

Division name

Department of Internal Medicine II

Zip code

Address

Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan

TEL

011-706-5915

Email

hmiyoshi@med.hokudai.ac.jp

Name of contact person

1st name
Middle name
Last name	Hideaki Miyoshi

Organization

Hokkaido University Hospital

Division name

Department of Internal Medicine II

Zip code

Address

Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan

TEL

011-706-5915

Homepage URL

Email

hmiyoshi@med.hokudai.ac.jp

Institute

Hokkaido University Hospital

Institute

Department

Personal name

Organization

Astellas Pharma Inc.

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

北海道大学病院（北海道）、小笠原クリニック札幌病院付属外来プラザ（北海道）、沖病院（北海道）、帯広厚生病院（北海道）、釧路赤十字病院（北海道）、さっぽろ糖尿病・甲状腺クリニック（北海道）、栗原内科（北海道）、高橋清仁クリニック（北海道）、苫小牧市立病院（北海道）、にわ糖尿病・内科クリニック（北海道）、北海道中央労災病院せき損センター（北海道）、萬田記念病院（北海道）

Date of disclosure of the study information

2015

Year

01

Month

26

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

2014

Year

12

Month

26

Day

Date of IRB

Anticipated trial start date

2015

Year

01

Month

30

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Assess the effectiveness of
Ipragliflozine on glucose metabolism, frequency of hypoglycemia, body weight, lipid metabolism, blood pressure, and liver function of in patients with type 2 diabetes treating with sulfonylurea

Registered date

2015

Year

01

Month

26

Day

Last modified on

2018

Year

06

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018659