UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of SGLT2 inhibitor switching from thiazolidine about body weight and metabolic-related factors in type 2 diabetes patients
Title of the study (Brief title)	The efficacy of SGLT2 inhibitor switching from thiazolidine in type 2 diabetes patients
Region	Japan

Condition
Condition	type 2 diabetes
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In type 2 diabetes patients during the treatment in the treatment of diabetes, including Pioglitazone, to assess the efficacy of SGLT2 inhibitor Dapagliflozin about body weight, changes in blood glucose control, lipid, blood pressure, and metabolic-related factors, such as liver function influence by switching Pioglitazone into Dapagliflozin.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Body weight and HbA1c at 24 weeks
Key secondary outcomes	Abdominal circumference Blood pressure Lipid metabolism Liver function Complete blood count, renal function, electrolyte Urine test Frequency of hypoglycemia Dose of antidiabetic drugs before and during clinical trial

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Keeping Pioglitazone
Interventions/Control_2	Switching Pioglitazone to Dapagliflozin
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	1) Age: 20 to 80 years old 2) HbA1c: 6.0-8.5% 3) BMI: 23 kg/m^2 and more 4) eGFR: 45ml/min/1.73m^2 and more 5) Taking Pioglitazone(15-30 mg per day) for more than 12 weeks 6) Written informed consent
Key exclusion criteria	1) Already taking SGLT2 inhibitor agents 2) With hypersensitivity to Dapagliflozin 3) With severe or unstable retinopathy 4) With severe liver or kidney disfunction 5) With severe diabetic ketosis, pre-coma, or coma 6) With severe infection or trauma, or in perioperation 7) With pregnancy 8) Patients who thought to be inappropriate to enter this study for some reasons by physician's judgments
Target sample size	70

Research contact person
Name of lead principal investigator	Hideaki Miyoshi
Organization	Hokkaido Unverstiy Hospital
Division name	Department of Internal Medicine II
Address	n14w5, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-706-5915
Email	hmiyoshi@med.hokudai.ac.jp

Public contact
Name of contact person	Kyu Yong Cho
Organization	Hokkaido Unverstiy Hospital
Division name	Department of Internal Medicine II
Address	n14w5, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-706-5915
Homepage URL
Email	kyuyong-cho@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido Unverstiy Hospital
Institute
Department

Funding Source
Organization	Hokkaido Unverstiy Hospital
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	北海道大学病院（北海道）、栗原内科（北海道）、青木内科（北海道）、釧路赤十字病院（北海道）、苫小牧市立病院（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）

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 13 Day
Anticipated trial start date	2016 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://onlinelibrary.wiley.com/doi/full/10.1111/dom.13557
Results
Other related information

Management information
Registered date	2016 Year 06 Month 20 Day
Last modified on	2018 Year 11 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026282