UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of dipeptidyl peptidase 4 inhibitors on Glomerulotubular regulation of sodium balance and circadian blood pressure rhythm.
Title of the study (Brief title)	Na balance and BP rhythm during the treatment with DPP4 inhibitor.
Region	Japan

Condition
Condition	Type 2 diabetic nephrology
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether DPP-4 (dipeptidyl peptidase 4) inhibitor can restore BP rhythm from non-dipper to dipper pattern, similar to that achieved with ARB and diuretics, and whether the effect differs between 2 DPP-4 inhibitors, Linagliptin and Teneligliptin.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Decrease in night/day ratio of blood pressure during 8 week treatment with DPP4 inhibitors (week 8)
Key secondary outcomes	1) increase in daytime urinary sodium excretion (day2) 2) decrease in glomerulotubular Na balance (SNa x GFR, tNa) 3) constancy of daily urinary Na excretion 4) sympathetic and parasympathetic nerve activity (assessed by heart rate variability) 5) HbA1c 6) urine anion gap, serum bicarbonate concentration

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	NO
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	oral administration of Linagliptin (5mg/day) once in the morning
Interventions/Control_2	oral administration of Teneligliptin (20mg/day) once in the morning
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) type 2 diabetes mellitus 2) age 20 or more years, regardless of gender 3) outpatient and inpatient 4) target HbA1c <7.0% is not achieved after approximately 3 months treatment with metformin 5) documented informed consent
Key exclusion criteria	1) GFR <30 30ml/min/1.73m2 or undergoing renal replacement therapy 2) severe ketosis, diabetic coma or pre-come 3) conditions with serious infection, perioperative period, and severe trauma 4) presence/possibility for pregnancy/lactation 5) GOT >100, or GPT >85 6) current treatment with insulin 7) any reason for ineligibility suggested by the attending doctor (history of allergic reaction to study medication)
Target sample size	60

Research contact person
Name of lead principal investigator	Michio FUKUDA
Organization	Nagoya City University Hospital
Division name	Division of Nephrology
Address	1 Kawasumi, Mizuho-ku, Nasgoya 467-8601, Japan
TEL	81-52-853-8221
Email	m-fukuda@med.nagoya-cu.ac.jp

Public contact
Name of contact person	Miyoko Suzuki
Organization	Nagoya City University Hospital
Division name	Clinical Research Management Center
Address	1 Kawasumi, Mizuho-ku, Nasgoya 467-8602, Japan
TEL	81-52-858-7215
Homepage URL	http://www.med.nagoya-cu.ac.jp/cr.dir/index.html
Email	clinical_research@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University Graduate School of Medical Sciences Department of Cardio-Renal Medicine and Hypertension
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Nagoya City East Medical Center Asahi Rousai Hospital
Name of secondary funｄer(s)	none

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	名古屋市立大学病院（愛知県）

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 16 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 10 Month 11 Day
Anticipated trial start date	2016 Year 10 Month 11 Day
Last follow-up date	2019 Year 10 Month 10 Day
Date of closure to data entry	2019 Year 12 Month 31 Day
Date trial data considered complete	2020 Year 01 Month 31 Day
Date analysis concluded	2020 Year 03 Month 31 Day

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

Management information
Registered date	2016 Year 10 Month 16 Day
Last modified on	2016 Year 10 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028113