Unique ID issued by UMIN | UMIN000045464 |
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Receipt number | R000051529 |
Scientific Title | Endocrinological evaluation of dawn phenomenon in diabetic patients and comparison of insulin glargine biosimillar (Insulin Glargine BS milliopen "Lilly") and glargine U-300 (Lantus XR) |
Date of disclosure of the study information | 2021/09/13 |
Last modified on | 2023/11/07 18:47:43 |
Endocrinological evaluation of dawn phenomenon in diabetic patients and comparison of insulin glargine biosimillar (Insulin Glargine BS milliopen "Lilly") and glargine U-300 (Lantus XR)
Endocrinological evaluation of dawn phenomenon in diabetic patients and comparison of insulin glargine biosimillar (Insulin Glargine BS milliopen "Lilly") and glargine U-300 (Lantus XR)
Endocrinological evaluation of dawn phenomenon in diabetic patients and comparison of insulin glargine biosimillar (Insulin Glargine BS milliopen "Lilly") and glargine U-300 (Lantus XR)
Endocrinological evaluation of dawn phenomenon in diabetic patients and comparison of insulin glargine biosimillar (Insulin Glargine BS milliopen "Lilly") and glargine U-300 (Lantus XR)
Japan |
diabetes
Endocrinology and Metabolism |
Others
NO
The present study was designed for the following purpose. First, to compare the blood glucose fluctuations and the levels of various hormones from midnight to early morning between the group of patients administered Glargine and the group administered Glargine XR, in order to achieve higher-quality blood glucose control. Second, to measure blood glucose level and the levels of various hormones including insulin-antagonistic hormones from midnight to early morning to clarify the association between changes in hormone levels and blood glucose fluctuations, thereby further characterizing the pathology of dawn phenomenon.
Efficacy
Mean blood glucose and standard deviation of Flash Glucose Monitoring and Average and standard deviation of blood glucose levels and at 3:00 am and 7:00 am.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Glargine XR
Glargine
20 | years-old | <= |
Not applicable |
Male and Female
Patients with type 1 and type 2 diabetes who have agreed to the purpose and content of this study and have voluntarily agreed to the document.
Patients with adrenal and pituitary diseases, patients who are chronically administered steroids, patients with cancer and patients with gestational diabetes.
50
1st name | shinobu |
Middle name | |
Last name | sato |
Chigasaki Municipal Hospital
Metabolism internal secretion internal medicine
253-0042
5-15-1, Honson, Chigasaki-shi, Kanagawa
0467-52-1111
shinobu@medical.email.ne.jp
1st name | masanori |
Middle name | |
Last name | hasebe |
Chigasaki Municipal Hospital
Metabolism internal secretion internal medicine
253-0042
5-15-1, Honson, Chigasaki-shi, Kanagawa
0467-52-1111
t186059g@yokohama-cu.ac.jp
Chigasaki Municipal Hospital
none
Self funding
Chigasaki Municipal Hospital
5-15-1, Honson, Chigasaki, Kanagawa
0467-52-1111
hosp_soumu@city.chigasaki.kanagawa.jp
NO
2021 | Year | 09 | Month | 13 | Day |
https://www.jstage.jst.go.jp/article/endocrj/70/8/70_EJ22-0562/_article
Published
https://www.jstage.jst.go.jp/article/endocrj/70/8/70_EJ22-0562/_article
47
The mean blood glucose was significantly lower in the BS group, although the fluctuation was similar. The BS group also exhibited significantly higher delta ACTH and delta cortisol than the XR group. In the BS group, delta Glu exhibited a significant negative correlation with delta ACTH and delta cortisol. Further, analysis of the dawn phenomenon and non-dawn phenomenon groups showed the mean CPR levels at 3:00 and 7:00 were significantly higher in the latter.
2023 | Year | 11 | Month | 07 | Day |
Of the 43 patients whose patient information was collected and analyzed, 20 were assigned to the BS group and 23 to the XR group. Clinical and biochemical backgrounds were c similar at baseline. Mean age was 62.4 years in the BS group and 67.0 years in the XR group, and mean HbA1c was 10.8% in the BS group, 10.5% in the XR group. Two patients in the BS group were diagnosed with type 1 diabetes, but none in the XR group. Also, The mean eGFR was 80.8mL/min/1.73 m2 in the BS group and 80.1mL/min/1.73 m2 in the XR group, there was no statistical difference.
This study involved patients aged 20 years or older who had already been diagnosed with type 1 and type 2 diabetes and who were scheduled to be hospitalized for 2 weeks in the Department of Metabolism and Endocrinology and at Chigasaki City Hospital. Patients who consented to the purpose and content of the study and voluntarily gave written consent, were included.After admission to the hospital, subjects were first given intensive insulin therapy with the main purpose of eliminating glucotoxicity. After confirming the resolution of glucotoxicity, continuous blood glucose measurements were conducted.After wearing the Abbott FreeStyle Libre Pro device, the assigned long-acting insulin was administered, and blood glucose changes were monitored using isCGM (intermittently scanned continuous glucose monitoring) from 0:00 a.m. until 7:00 a.m.. Blood samples were also collected at 3:00 a.m. and 7:00 a.m. to measure blood glucose levels, C-peptide, growth hormone, cortisol, ACTH, catecholamines, and glucagon.
No significant adverse events associated with the clinical study were observed.
The primary endpoints were mean value and standard deviation of intermittently scanned continuous glucose monitoring (isCGM) and blood glucose (Glu) levels at 3:00 and 7:00. The secondary endpoints were GH, cortisol, ACTH, catecholamines, and glucagon levels at 3:00 and 7:00.
Completed
2018 | Year | 02 | Month | 16 | Day |
2018 | Year | 02 | Month | 16 | Day |
2018 | Year | 07 | Month | 31 | Day |
2022 | Year | 03 | Month | 31 | Day |
2021 | Year | 09 | Month | 13 | Day |
2023 | Year | 11 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051529
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