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 |
* 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
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
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
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
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
