UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024426
Receipt number 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 11:36:21

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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