Unique ID issued by UMIN | UMIN000010343 |
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Receipt number | R000012104 |
Scientific Title | Evaluation of pharmacodynamics and safety of teneligliptin in type 2 diabetic patients with chronic renal dysfunction |
Date of disclosure of the study information | 2013/03/28 |
Last modified on | 2015/03/31 13:20:12 |
Evaluation of pharmacodynamics and safety of teneligliptin in type 2 diabetic patients with chronic renal dysfunction
Evaluation of pharmacodynamics and safety of teneligliptin in type 2 diabetic patients with chronic renal dysfunction
Evaluation of pharmacodynamics and safety of teneligliptin in type 2 diabetic patients with chronic renal dysfunction
Evaluation of pharmacodynamics and safety of teneligliptin in type 2 diabetic patients with chronic renal dysfunction
Japan |
Patients with Type 2 diabetes [chronic renal dysfunction (CKD Stage:over G3b)]
Endocrinology and Metabolism |
Others
NO
The effects of teneligliptin 20 mg, single and repeated administration, on plasma teneligliptin concentration and response of c-peptide and incretin to the meal test in type 2 diabetic patients with chronic renal dysfunction.
Safety,Efficacy
Plasma concentration of teneligliptin
Changes in active GLP-1 levels
C-peptide- and glucagon-response to the meal test
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Teneligliptin 20mg/day 1week
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients agreed to participate in this study with a written consent
2) Gender: agnostic
3) Age: 20 years old or older when obtaining consent
4) Inpatient and outpatient: hospitalization
5) Patients who continued diet and exercise therapy more than 12 weeks before day1.
Exercise therapy is not essential if it is prohibited because of the complication.
6) CKD stage over G3b based on serum Cystatin C level within four weeks of day1.
1)Type 1 diabetes,diabetes arising from the failure of pancreas,or secondary diabetes (eg. Cushing's syndrome and acromegaly)
2) Patient correspond to contraindications of teneligliptin
3) Excessive alcohol addicts: patient who take average net more than 60 g alcohol every single day (more than following: 3 bottles of sake, 1 with shochu, 3 bottles of beer, 3 glasses of whiskey or brandy(double),and 5 glasses of wine)
4) Pregnant, lactating, possible pregnant patient
5) Patient judged as ineligible for this study by the researcher
12
1st name | |
Middle name | |
Last name | Yoshiyuki Hamamoto |
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Center for Diabetes and Endocrinology
2-4-20 Ohgimachi, Kita-ku, Osaka, JAPAN
1st name | |
Middle name | |
Last name |
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Center for Diabetes and Endocrinology
2-4-20 Ogimachi, Kita-ku, Osaka, JAPAN
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Self funding
NO
2013 | Year | 03 | Month | 28 | Day |
Unpublished
Completed
2012 | Year | 12 | Month | 22 | Day |
2013 | Year | 01 | Month | 18 | Day |
2014 | Year | 04 | Month | 01 | Day |
2014 | Year | 04 | Month | 01 | Day |
2014 | Year | 04 | Month | 01 | Day |
2014 | Year | 08 | Month | 01 | Day |
2013 | Year | 03 | Month | 28 | Day |
2015 | Year | 03 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012104
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