Unique ID issued by UMIN | UMIN000029015 |
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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 | 2020/03/22 21:01:16 |
Efficacy of the medical compound of teneligliptin 20 mg and canagliflozin 100 mg with Free Style Libre
Efficacy of the medical compound of teneligliptin and canagliflozin with Free Style Libre
Efficacy of the medical compound of teneligliptin 20 mg and canagliflozin 100 mg with Free Style Libre
Efficacy of the medical compound of teneligliptin and canagliflozin with Free Style Libre
Japan |
type 2 diabetes mellitus
Endocrinology and Metabolism |
Others
NO
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.
Efficacy
Blood glucose transition (standard deviation and MAGE), and average blood glucose level by a Free Style Libre.
Diabetes Treatment Satisfaction: DTSQ, glycoalbumin, urine albumin creatinine ratio, eGFR, glucagon, bodyweight.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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.
15 | years-old | <= |
85 | years-old | >= |
Male and Female
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.
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
40
1st name | Takahiro |
Middle name | |
Last name | Tosaki |
TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
Diabetes and Endocrinology
4680009
2-1007 Motoueda, Tenpaku-ku, Nagoya City 468-0009, Japan
052-800-2333
nrd49075@nifty.com
1st name | Takahiro |
Middle name | |
Last name | Tosaki |
TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
Diabetes and Endocrinology
4680009
2-1007 Motoueda, Tenpaku-ku, Nagoya City 468-0009, Japan
052-800-2333
nrd49075@nifty.com
TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
Self funding
Division of Diabetes, Department of Internal Medicine, Aichi Medical University School of Medicine
Ethic commitee of TDE Healthcare Corporation
2-1007 Motoueda, Tenpaku-ku, Nagoya City 468-0009, Japan
0528002333
nrd49075@nifty.com
NO
医療法人TDE 糖尿病・内分泌内科クリニックTOSAKI
2017 | Year | 09 | Month | 05 | Day |
Partially published
http://diabetes.diabetesjournals.org/content/67/Supplement_1/2304-PUB?utm_source=TrendMD&utm_medium=cpc&utm_campaign=Diabetes_TrendMD_0
Open public recruiting
2017 | Year | 09 | Month | 04 | Day |
2017 | Year | 09 | Month | 05 | Day |
2017 | Year | 09 | Month | 05 | Day |
2020 | Year | 03 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033158
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