Unique ID issued by UMIN | UMIN000029197 |
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Receipt number | R000033252 |
Scientific Title | The effect of additional administration of empagliflozin on patients with linagliptin on renal function |
Date of disclosure of the study information | 2017/09/19 |
Last modified on | 2020/03/22 20:56:19 |
The effect of additional administration of empagliflozin on patients with linagliptin on renal function
The effect of additional administration of empagliflozin on patients with linagliptin on renal function
The effect of additional administration of empagliflozin on patients with linagliptin on renal function
The effect of additional administration of empagliflozin on patients with linagliptin on renal function
Japan |
type 2 diabetes mellitus
Endocrinology and Metabolism |
Others
NO
We study about efficacy to the renal function of empagliflozin which is added to linaigliptin in clinical use.
Efficacy
Not applicable
Urine albumin creatinine ratio, urin L-FABP.
Glycoalbumin, HbA1c, bodyweight, serum insurin, C-peptide, glucagon, eGFR.
Blood glucose transition (standard deviation and MAGE), and average blood glucose level by a Free Style Libre.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Patients are equipped with a Free Style Libre for 2 weeks from the start of study.
4 weeks after the start of study, patients are randomized to two groups.
Group A: empagliflozin 10mg is added and administration is continued for 12 weeks, and 8 weeks after empagliflozin administration, Free Style Libre Pro is worn for 2 weeks.
At the start of study and 4th week, 12th week, 16th week, we measure these following values on an empty stomach early in the morning, urine albumin creatinine ratio(mg/gCr), urin L-FABP, body weight, BMI, systolic blood pressure, diastolic blood pressure, HbA1c, glycoalbmin, serum AST, ALT, gamma-GTP, BUN, creatinine, UA, eGFR, LDL-C, HDL-C, TG, glucose level, insulin, C-peptide, glucagon.
Group B: glimepiride 1mg is added and administration is continued for 12 weeks, and 8 weeks after glimepiride administration, Free Style Libre Pro is worn for 2 weeks.
15 | years-old | <= |
75 | 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 8 weeks and who have been treated with linagliptin 5 mg and without SGLT2 inhibitors and sulfonyulureas.
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
052-800-2333
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 | 19 | Day |
Unpublished
Open public recruiting
2017 | Year | 09 | Month | 05 | Day |
2017 | Year | 09 | Month | 19 | Day |
2017 | Year | 09 | Month | 19 | Day |
2020 | Year | 03 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033252
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