UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000019098
Receipt No. 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 (Ver. 10)

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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
Institute Graduate School of Medicine, University of the Ryukyus
Institute
Department

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022083