UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024426
Receipt No. R000028113
Scientific Title Effect of dipeptidyl peptidase 4 inhibitors on Glomerulotubular regulation of sodium balance and circadian blood pressure rhythm.
Date of disclosure of the study information 2016/10/16
Last modified on 2016/10/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effect of dipeptidyl peptidase 4 inhibitors on Glomerulotubular regulation of sodium balance and circadian blood pressure rhythm.
Acronym Na balance and BP rhythm during the treatment with DPP4 inhibitor.
Scientific Title Effect of dipeptidyl peptidase 4 inhibitors on Glomerulotubular regulation of sodium balance and circadian blood pressure rhythm.
Scientific Title:Acronym 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
1st name
Middle name
Last name Michio FUKUDA
Organization Nagoya City University Hospital
Division name Division of Nephrology
Zip code
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
1st name
Middle name
Last name Miyoko Suzuki
Organization Nagoya City University Hospital
Division name Clinical Research Management Center
Zip code
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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2016 Year 10 Month 11 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.