UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029015 |
|---|---|
| Receipt number | R000033158 |
| Scientific Title | Efficacy of the medical compound of teneligliptin 20 mg and canagliflozin 100 mg with Free Style Libre |
| Date of disclosure of the study information | 2017/09/05 |
| Last modified on | 2024/10/27 20:06:33 |
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Basic information
Public title
Efficacy of the medical compound of teneligliptin 20 mg and canagliflozin 100 mg with Free Style Libre
Acronym
Efficacy of the medical compound of teneligliptin and canagliflozin with Free Style Libre
Scientific Title
Efficacy of the medical compound of teneligliptin 20 mg and canagliflozin 100 mg with Free Style Libre
Scientific Title:Acronym
Efficacy of the medical compound of teneligliptin and canagliflozin with Free Style Libre
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 study about efficacy of the compound of teneligliptin 20 mg and canagliflozin 100 mg with a Free Style Libre in out-patients who have been treated with teneligliptin 20 mg or canagliflozin 100 mg.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose transition (standard deviation and MAGE), and average blood glucose level by a Free Style Libre.
Key secondary outcomes
Diabetes Treatment Satisfaction: DTSQ, glycoalbumin, urine albumin creatinine ratio, eGFR, glucagon, bodyweight.
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
We continue same dose of any antidiabetic drugs except for teneligliptin and canagliflozin.
Patients are equipped with a Free Style Libre for 14 days from the start of study.
Teneligliptin 20 mg or canagliflozin 100 mg is administered for 1 week and a medical compound of teneligliptin 20 mg and canagliflozin 100 mg for 1 week with a Free Style Libre.
After that, a medical compound of teneligliptin and canagliflozin is administered for 3 weeks.
We conduct DTSQ (Diabetes Treatment Satisfaction Questionnaire) at the start and the end of study.
At the start and the end of study, we measure these following values on an empty stomach, body weight, BMI, systolic blood pressure, diastolic blood pressure, HbA1c, glycoalbmin, serum AST, ALT, gamma-GTP, BUN, creatinine, UA, eGFR, urine albumin creatinine ratio(mg/gCr), LDL-C, HDL-C, TG, glucose level, insulin, C-peptide, glucagon.
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
| 15 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Out-patients with type 2 diabetes whose HbA1c are more than 6.5% and less than 15% and who have no changes of diabetic treatment (e.g. diet therapy, exercise cure, medication) within the past 12 weeks and who have been treated with teneligliptin 20 mg or canagliflozin 100 mg.
Key exclusion criteria
1. Patients who have renal dysfunction (eGFR is less than 30ml/min/1.73m2)
2. Pregnant women
3. Patients judged by the doctor to be ineligible
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Tosaki |
Organization
TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
Division name
Diabetes and Endocrinology
Zip code
4680009
Address
2-1007 Motoueda, Tenpaku-ku, Nagoya City 468-0009, Japan
TEL
052-800-2333
nrd49075@nifty.com
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Tosaki |
Organization
TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
Division name
Diabetes and Endocrinology
Zip code
4680009
Address
2-1007 Motoueda, Tenpaku-ku, Nagoya City 468-0009, Japan
TEL
052-800-2333
Homepage URL
nrd49075@nifty.com
Sponsor or person
Institute
TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
Institute
Department
Personal name
Funding Source
Organization
TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Division of Diabetes, Department of Internal Medicine, Aichi Medical University School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethic commitee of TDE Healthcare Corporation
Address
2-1007 Motoueda, Tenpaku-ku, Nagoya City 468-0009, Japan
Tel
0528002333
nrd49075@nifty.com
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
医療法人TDE 糖尿病・内分泌内科クリニックTOSAKI
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 05 | Day |
Related information
URL releasing protocol
https://jglobal.jst.go.jp/detail?JGLOBAL_ID=201902224235021281&rel=1#%7B%22category%22%3A%220%22%2C%
Publication of results
Published
Result
URL related to results and publications
https://jglobal.jst.go.jp/detail?JGLOBAL_ID=201902224235021281&rel=1#%7B%22category%22%3A%220%22%2C%
Number of participants that the trial has enrolled
18
Results
In both groups, where patients switched from teneligliptin to the Ten/Can combination and from canagliflozin to the Ten/Can combination, significant improvements in glycemic control were observed with LibrePro.
Results date posted
| 2024 | Year | 10 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
18 outpatients diagnosed with diabetes with HbA1c levels between 6.5% and 15%, receiving treatment with either Ten 20mg or Can 100mg, and no changes in diabetes treatment (diet, exercise, or drug therapy) in the past 4 weeks
Participant flow
Patients were required to wear the Free Style Libre Pro for two weeks and were administered the following:
First week: Ten 20mg or Can 100mg
Second week: Ten/Can combination
(Diabetes medications other than Ten or Can were continued at the same dose during the period)
After monitoring with the Free Style Libre Pro ended, patients continued to receive the Ten/Can combination for three weeks and visited the outpatient clinic.
A patient treatment satisfaction survey (Diabetes Treatment Satisfaction Questionnaire: DTSQ) was conducted at the start and end of the study. Weight and blood pressure were measured while fasting, and biochemistry tests were performed.
Adverse events
Nothing
Outcome measures
7-day average blood glucose value on Libre Pro
Blood glucose fluctuation SD (median)
Average blood glucose fluctuation range MAGE (mean) on the 7th day after administration of each drug
Fasting blood glucagon
Weight
DTSQ
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 05 | Day |
Last modified on
| 2024 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033158
