Unique ID issued by UMIN | UMIN000028988 |
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Receipt number | R000033168 |
Scientific Title | Which is the most compatible combination of oral hypoglycemic agents that incretin action are considered used together with basal insulin? Comparison of Vildagliptin 100 mg +Metformin 500 mg vs. Vildagliptin 100 mg +Miglitol 150 mg vs. Metformin 500 mg+Miglitol 150 mg using FreeStyle Libre Pro: randomised triple crossover study |
Date of disclosure of the study information | 2017/09/04 |
Last modified on | 2018/05/08 10:54:02 |
Which is the most compatible combination of oral hypoglycemic agents that incretin action are considered used together with basal insulin? Comparison of Vildagliptin 100 mg +Metformin 500 mg vs. Vildagliptin 100 mg +Miglitol 150 mg vs. Metformin 500 mg+Miglitol 150 mg using FreeStyle Libre Pro: randomised triple crossover study
Comparison of Vildagliptin 100 mg +Metformin 500 mg vs. Vildagliptin 100 mg +Miglitol 150 mg vs. Metformin 500 mg+Miglitol 150 mg using FreeStyle Libre Pro: randomised triple crossover study
Which is the most compatible combination of oral hypoglycemic agents that incretin action are considered used together with basal insulin? Comparison of Vildagliptin 100 mg +Metformin 500 mg vs. Vildagliptin 100 mg +Miglitol 150 mg vs. Metformin 500 mg+Miglitol 150 mg using FreeStyle Libre Pro: randomised triple crossover study
Comparison of Vildagliptin 100 mg +Metformin 500 mg vs. Vildagliptin 100 mg +Miglitol 150 mg vs. Metformin 500 mg+Miglitol 150 mg using FreeStyle Libre Pro: randomised triple crossover study
Japan |
type 2 diabetes
Endocrinology and Metabolism |
Others
NO
To investigate which is the most compatible combination of oral hypoglycemic agents that incretin action are considered used together with basal insulin, Vildagliptin 100 mg +Metformin 500 mg, Vildagliptin 100 mg +Miglitol 150 mg or Metformin 500 mg+Miglitol 150 mg.
Efficacy
24h glycemic variability percentage (GVP)
24h percentage of time in target range (70~140 mg/dL)
24h mean absolute glucose (MAG)
mean glucose level (24h, 00:00~06:00, 08:00~24:00)
standard deviation (SD)(24h, 00:00~06:00, 08:00~24:00)
coefficient of variation (CV)(24h, 00:00~06:00, 08:00~24:00)
MAGE
MODD
ADRR
HIgh blood glucose index (HBGI)
Highest postprandial glucose level within 3 hours after each meal
AOC (<70 mg/dL) for glycemic variability (24h)
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
3
Treatment
Medicine |
FreeStyle Libre Pro is worn after admission. Vildagliptin 100 mg +Metformin 500 mg are evaluated on day 3 and day 4. Then, Vildagliptin 100 mg +Miglitol 150 mg are evaluated on day 8 and day 9. Then, Metformin 500 mg+Miglitol 150 mg are evaluated on day 13 and day 14.
FreeStyle Libre Pro is worn after admission. Metformin 500 mg+Miglitol 150 mg are evaluated on day 3 and day 4. Then, Vildagliptin 100 mg +Metformin 500 mg are evaluated on day 8 and day 9. Then, Vildagliptin 100 mg +Miglitol 150 mg are evaluated on day 13 and day 14.
FreeStyle Libre Pro is worn after admission. Vildagliptin 100 mg +Miglitol 150 mg are evaluated on day 3 and day 4. Then, Metformin 500 mg+Miglitol 150 mg are evaluated on day 8 and day 9. Then, Vildagliptin 100 mg +Metformin 500 mg are evaluated on day 13 and day 14.
20 | years-old | <= |
90 | years-old | > |
Male and Female
type 2 diabetic patients medicated with insulin glargine 300 U/ml for 3 month or longer
severe renal dysfunction (eGFR less than 45)
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
Self funding
Self funding
NO
2017 | Year | 09 | Month | 04 | Day |
Unpublished
Completed
2017 | Year | 09 | Month | 04 | Day |
2017 | Year | 09 | Month | 04 | Day |
2017 | Year | 09 | Month | 04 | Day |
2018 | Year | 05 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033168
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