Unique ID issued by UMIN | UMIN000025952 |
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Receipt number | R000029835 |
Scientific Title | Which is the best long-acting insulin to reduce hypoclycemia ? Comparison of Insulin glargine 300 U/ml vs. Insulin degludec vs. Insulin glargine 100 U/ml using FreeStyle Libre Pro: randomised triple crossover study |
Date of disclosure of the study information | 2017/02/01 |
Last modified on | 2018/05/18 11:18:14 |
Which is the best long-acting insulin to reduce hypoclycemia ? Comparison of Insulin glargine 300 U/ml vs. Insulin degludec vs. Insulin glargine 100 U/ml using FreeStyle Libre Pro: randomised triple crossover study
Comparison of Insulin glargine 300 U/ml vs. Insulin degludec vs. Insulin glargine 100 U/ml using FreeStyle Libre Pro: randomised triple crossover study
Which is the best long-acting insulin to reduce hypoclycemia ? Comparison of Insulin glargine 300 U/ml vs. Insulin degludec vs. Insulin glargine 100 U/ml using FreeStyle Libre Pro: randomised triple crossover study
Comparison of Insulin glargine 300 U/ml vs. Insulin degludec vs. Insulin glargine 100 U/ml using FreeStyle Libre Pro: randomised triple crossover study
Japan |
diabetes
Endocrinology and Metabolism |
Others
NO
To investigate which is the best long-acting insulin to reduce hypoclycemia, Insulin glargine 300 U/ml, Insulin degludec or Insulin glargine 100 U/ml .
Safety
AOC (<70 mg/dL) for glycemic variability (0:00-6:00, 8:00-24:00, 24:00)
00:00 to 6:00 percentage of time in hypoglycemic range (<54 mg/dL)
mean absolute glucose (MAG)
glycemic variability percentage (GVP)
mean glucose level (0:00-6:00, 24:00)
SD (0:00-6:00, 24:00)
coefficient of variation (CV) (0:00-6:00, 24:00)
M-value (0:00-6:00, 24:00)
MAGE
MODD
ADRR
low blood glucose index (LBGI)
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
3
Treatment
Medicine |
FreeStyle Libre Pro is worn after admission. Insulin glargine 300 U/ml are evaluated on day 3 and day 4. Then, Insulin degludec are evaluated on day 8 and day 9. Then, Insulin glargine 100 U/ml are evaluated on day 13 and day 14.
FreeStyle Libre Pro is worn after admission. Insulin degludec are evaluated on day 3 and day 4. Then, Insulin glargine 100 U/ml are evaluated on day 8 and day 9. Then, Insulin glargine 300 U/ml are evaluated on day 13 and day 14.
FreeStyle Libre Pro is worn after admission. Insulin glargine 100 U/ml are evaluated on day 3 and day 4. Then, Insulin glargine 300 U/ml are evaluated on day 8 and day 9. Then, Insulin degludec are evaluated on day 13 and day 14.
20 | years-old | <= |
90 | years-old | >= |
Male and Female
type 2 diabetic patients medicated long-acting insulin for 3 month or longer
severe renal dysfunction (serum creatinine level over 2.0 mg/dL)
judged to be unsuitable for participation for medical reasons
30
1st name | |
Middle name | |
Last name | Soichi Takeishi |
General Inuyamachuo Hospital
Department of Diabetes
6, futakozuka, goroumaru, Inuyama-city, Aichi, 484-8511, Japan.
0568-62-8111
souichi19811225@yahoo.co.jp
1st name | |
Middle name | |
Last name | Soichi Takeishi |
General Inuyamachuo Hospital
Department of Diabetes
6, futakozuka, goroumaru, Inuyama-city, Aichi, 484-8511, Japan.
0568-62-8111
souichi19811225@yahoo.co.jp
General Inuyamachuo Hospital
General Inuyamachuo Hospital
Self funding
NO
2017 | Year | 02 | Month | 01 | Day |
Unpublished
Completed
2017 | Year | 02 | Month | 01 | Day |
2017 | Year | 02 | Month | 01 | Day |
2017 | Year | 02 | Month | 01 | Day |
2018 | Year | 05 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029835
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