Unique ID issued by UMIN | UMIN000029881 |
---|---|
Receipt number | R000034133 |
Scientific Title | Investigation of titration method in basal insulin therapy using Vildagliptin 100 mg +Metformin 500 mg: randomised crossover study |
Date of disclosure of the study information | 2017/11/08 |
Last modified on | 2018/07/18 15:10:12 |
Investigation of titration method in basal insulin therapy using Vildagliptin 100 mg +Metformin 500 mg: randomised crossover study
Investigation of titration method in basal insulin therapy using Vildagliptin 100 mg +Metformin 500 mg
Investigation of titration method in basal insulin therapy using Vildagliptin 100 mg +Metformin 500 mg: randomised crossover study
Investigation of titration method in basal insulin therapy using Vildagliptin 100 mg +Metformin 500 mg
Japan |
Type 2 diabetes
Endocrinology and Metabolism |
Others
NO
To investigate an early combination efficacy of Vildagliptin 100 mg+Metformin 500 mg in basal insulin therapy titration
Efficacy
15% reduction achieving number of days [mean glucose level (24:00)]
15% reduction achieving number of days [mean glucose level (0:00-8:00)]
15% reduction achieving number of days [mean glucose level (8:00-24:00)]
15% reduction achieving number of days [SD (0:00-8:00)]
15% reduction achieving number of days [SD (24:00)]
15% reduction achieving number of days [SD (8:00-24:00)]
Glycemic variability percentage (GVP) from the day before intervention start to 15% reduction achieving
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
FreeStyle Libre Pro is attached after admission. Metformin 500 mg are started to use from day3 and dose of Glargine300 increases from day5. Then, dose of Glargine300 increases from day10 and Metformin 500 mg are started to use from day12.
FreeStyle Libre Pro is attached after admission. dose of Glargine300 increases from day3 and Metformin 500 mg are started to use from day5. Then, Metformin 500 mg are started to use from day10 and dose of Glargine300 increases from day12.
20 | years-old | <= |
90 | years-old | >= |
Male and Female
type 2 diabetic patients medicated Vildagliptin 100 mg+Glargine300 for 3 month or longer
renal dysfunction (patients whose estimated glomerular filtration rate was less than 45 ml/min/1.73m2)
judged to be unsuitable for participation for medical reasons
30
1st name | |
Middle name | |
Last name | Soichi Takeishi |
General Inuyama Chuo Hospital
Department of Diabetes
6, Futagozuka, Goromaru, Inuyama-city, Aichi, 484-8511, Japan.
0568-62-8111
souichi19811225@yahoo.co.jp
1st name | |
Middle name | |
Last name | Soichi Takeishi |
General Inuyama Chuo Hospital
Department of Diabetes
6, Futagozuka, Goromaru, Inuyama-city, Aichi, 484-8511, Japan.
0568-62-8111
souichi19811225@yahoo.co.jp
General Inuyama Chuo Hospital
General Inuyama Chuo Hospital
Self funding
NO
2017 | Year | 11 | Month | 08 | Day |
Unpublished
Completed
2017 | Year | 11 | Month | 08 | Day |
2017 | Year | 11 | Month | 08 | Day |
2017 | Year | 11 | Month | 08 | Day |
2018 | Year | 07 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034133