UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019098
Receipt number R000022083
Scientific Title Analysis of efficacy of the SGLT2 inhibitor alone or in combination with the DPP-4 inhibitor on urinary and plasma DPP-4 activities in obese patients with type 2 diabetes.
Date of disclosure of the study information 2015/09/29
Last modified on 2019/11/20 23:17:14

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Basic information

Public title

Analysis of efficacy of the SGLT2 inhibitor alone or in combination with the DPP-4 inhibitor on urinary and plasma DPP-4 activities in obese patients with type 2 diabetes.

Acronym

Analysis of efficacy of the SGLT2 inhibitor alone or in combination with the DPP-4 inhibitor on urinary and plasma DPP-4 activities in obese patients with type 2 diabetes.

Scientific Title

Analysis of efficacy of the SGLT2 inhibitor alone or in combination with the DPP-4 inhibitor on urinary and plasma DPP-4 activities in obese patients with type 2 diabetes.

Scientific Title:Acronym

Analysis of efficacy of the SGLT2 inhibitor alone or in combination with the DPP-4 inhibitor on urinary and plasma DPP-4 activities in obese patients with type 2 diabetes.

Region

Japan


Condition

Condition

Type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the influence of canagliflozin alone or in combination with teneligliptin on urinary and plasma DPP-4 activities in obese patients with type 2 diabetes inadequately controlled.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Changes in HbA1c, and urinary and plasma DPP-4 activities after 12 weeks of treatment with canagliflozin

Key secondary outcomes

Change in glycemic, insulinemic, lipid, and hepatic parameters, body weight, visceral fat area, urinary and plasma DPP-4 activities, and blood pressure and heart rate after treatment with canagliflozin alone or in combination with teneligliptin.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Canagliflozin100mg(24weeks),Teneligliptin(12weeks)

Interventions/Control_2


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

75 years-old >

Gender

Male and Female

Key inclusion criteria

1) HbA1c levels of >=7.0% to <=10.0% (NGSP)
2) BMI >=25 kg/m2
3) Under treatment with fixed diet, exercise ,medication therapy>=4 weeks
4) Age >=20 to <75 years
5) Submission of written informed consent for participation in this study

Key exclusion criteria

1) Under treatment with SGLT2 inhibitor,DPP-4 inhibitor, insulin, or GLP-1 analog
2) Severe ketosis, diabetic coma, or diabetic precoma within the past six months
3) Type 1 diabetes
4) Pituitary gland dysfunction, adrenal gland dysfunction
5) Severe infectious diseases, pre or post surgery, and serious trauma
6) Pregnant women, women suspected of being pregnant, or lactating women
7) Severe renal function disorder (eGFR < 45)
8) Severe liver function disorder
9) History of malignant tumor
10) Cardiac arrest (class of IV in NYHA)
11) Self-contained device such as pacemakers
12) Wearable devices such as Holter electrocardiographs
13) Implantable metallic medical devices

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroaki Masuzaki

Organization

Graduate School of Medicine, University of the Ryukyus

Division name

Division of Endocrinology, Diabetes and Metabolism, Hematology, Rheumatolog

Zip code


Address

207 Uehara, Nishihara, Okinawa

TEL

098-895-3331

Email

hiroaki@med.u-ryukyu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Eriko Kawamoto

Organization

University of the Ryukyus Hospital

Division name

Division of Endocrinology, Diabetes and Metabolism, Hematology, Rheumatolog

Zip code


Address

207 Uehara, Nishihara, Okinawa

TEL

098-895-3331

Homepage URL


Email

ikyoku@ryudai2nai.com


Sponsor or person

Institute

Graduate School of Medicine, University of the Ryukyus

Institute

Department

Personal name



Funding Source

Organization

Mitsubishi Tanabe Pharma Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



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

豊見城中央病院(沖縄県)、田仲医院(沖縄県)


Other administrative information

Date of disclosure of the study information

2015 Year 09 Month 29 Day


Related information

URL releasing protocol

none

Publication of results

Unpublished


Result

URL related to results and publications

none

Number of participants that the trial has enrolled

12

Results

Canagliflozin(Cana) 12-week administration improved HbA1c, plasma DPP4 activity, BW, BMI, VFM, abdominal circumference, fasting serum glucose, fasting serum insulin, serum C-peptide, and ALT. Among the 12 cases, HbA1c, AST, and ALT were decreased and heart rate was increased in the group (12W vs.24W) that was combined with Teneligliptin(Tene) in 9 cases.

Results date posted

2019 Year 11 Month 20 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

there are 12 participants(6 men and 6 women). average age was 50 years. BMI was 30. HbA1c was 7.96%. Visceral fat area was 163 cm2.

Participant flow

Participants from 0-12 weeks were 6 males and 6 females.
Among them, 4 men and 5 women observed the addition of tenerigliptin at 12-24 weeks. There was no dropout.

Adverse events

There were no serious adverse events. Minor adverse events include: cold 3 cases, frequent urination 1 case, headache 1 case, cervical numbness 1 case, urination pain 1 case, tinnitus 1 case, ear obstruction 1 case, left tympanic membrane 1 case, skin pruritus 1 case A case of peri-arthritis of the shoulder was observed, all of which improved or disappeared after follow-up or symptomatic treatment.

Outcome measures

Changes in HbA1c, and urinary and plasma DPP-4 activities after 12 weeks of treatment with canagliflozin
Change in glycemic, insulinemic, lipid, and hepatic parameters, body weight, visceral fat area, urinary and plasma DPP-4 activities, and blood pressure and heart rate after treatment with canagliflozin alone or in combination with teneligliptin.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 05 Month 20 Day

Date of IRB

2018 Year 03 Month 12 Day

Anticipated trial start date

2015 Year 10 Month 01 Day

Last follow-up date

2018 Year 02 Month 28 Day

Date of closure to data entry

2018 Year 04 Month 22 Day

Date trial data considered complete

2018 Year 04 Month 22 Day

Date analysis concluded

2018 Year 06 Month 30 Day


Other

Other related information

In this study, we did not have enough participants for an accurate analysis.


Management information

Registered date

2015 Year 09 Month 24 Day

Last modified on

2019 Year 11 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022083


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name