UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of concomitant administration of DPP-4 and SGLT2 inhibitors in Japanese patients with type 2 diabetes
Title of the study (Brief title)	Effects of concomitant administration of DPP-4 and SGLT2 inhibitors in Japanese patients with type 2 diabetes
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate effects of concomitant administration of DPP-4 and SGLT2 inhibitors on BMI, glycemic control, plasma lipids, and hepatic function in type 2 diabetic patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Body mass index, HbA1c, plsma total cholesterol, HDL and LDL cholesterol, triglyceride, AST, ALT, and gamma-GTP levels at 6 months after the start of drug treatment
Key secondary outcomes	Plasma uric acid level at 6 months after the start of drug treatment

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is 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	Administration of SGLT2 inhibitor (luseogliflozin 2.5 mg q.d., dapagliflozin 5 mg q.d., tofogliflozin 20 mg q.d., empagliflozin 10 mg q.d., or canagliflozin 100 mg q.d.) for 6 months
Interventions/Control_2	Concomitant administration of SGLT2 inhibitor and DPP-4 inhibitor (sitagliptin 50 mg q.d., vildagliptin 50 mg b.i.d., alogliptin 25 mg q.d., anagliptin 100 mg b.i.d., or linagliptin 5 mg q.d.) for 6 months
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	30 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Type 2 diabetic patients. Obtained written informed consent from the patients before participation.
Key exclusion criteria	Having severe nephropathy.
Target sample size	220

Research contact person
Name of lead principal investigator	Masataka Kusunoki
Organization	Nagoya University
Division name	Research Center of Health, Physical Fitness and Sports
Address	Furo-cho, Chikusa-ku, Nagoya
TEL	052-789-3946
Email	info@tonyo.jp

Public contact
Name of contact person	Masataka Kusunoki
Organization	Nagoya University
Division name	Research Center of Health, Physical Fitness and Sports
Address	Furo-cho, Chikusa-ku, Nagoya
TEL	052-789-3946
Homepage URL
Email	info@tonyo.jp

Sponsor
Institute	Nagoya University
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
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	医療法人社団織田会あきしまクリニック（愛知県）

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 02 Day
Anticipated trial start date	2015 Year 03 Month 02 Day
Last follow-up date	2016 Year 10 Month 27 Day
Date of closure to data entry	2016 Year 11 Month 04 Day
Date trial data considered complete	2016 Year 11 Month 29 Day
Date analysis concluded	2016 Year 12 Month 11 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 03 Month 07 Day
Last modified on	2017 Year 03 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030380