Unique ID issued by UMIN | UMIN000012458 |
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Receipt number | R000014581 |
Scientific Title | Study of impact of switching from existing long-acting insulin to insulin degludec, a new long-acting insulin, on glycemic control and frequency of hypoglycemia (Study on inpatients) |
Date of disclosure of the study information | 2013/12/02 |
Last modified on | 2013/12/02 15:24:29 |
Study of impact of switching from existing long-acting insulin to insulin degludec, a new long-acting insulin, on glycemic control and frequency of hypoglycemia (Study on inpatients)
Study of glycemic control and frequency of hypoglycemia after switching to insulin degludec (Study on inpatients)
Study of impact of switching from existing long-acting insulin to insulin degludec, a new long-acting insulin, on glycemic control and frequency of hypoglycemia (Study on inpatients)
Study of glycemic control and frequency of hypoglycemia after switching to insulin degludec (Study on inpatients)
Japan |
type 2 diabetes
Endocrinology and Metabolism |
Others
NO
To examine the efficacy and safety of switching from existing long-acting insulin to insulin degludec for inpatients
Safety,Efficacy
Change of HbA1c levels after 12 weeks from baseline, achievement rate of HbA1c <7.0% and frequency of hypoglycemia in observation period
1)Percentage of time periods at which blood glucose level is 70mg/dL or lower during using CGM 2)Percentage of time periods at which blood glucose level is 180mg/dL or more during using CGM 3)Average blood glucose level, standard deviation (SD) of blood glucose and coefficient of variation (CV) during wearing CGM 4)Frequency of blood glucose level is 70mg/dL or lower at self-monitoring of blood glucose (SMBG) conducted 6 times a day within 2 weeks of switching 5)SD of blood glucose and intraindividual variability (CV%) at SMBG before breakfast 6)Change of glycoalbumin (GA) level and 1.5AG level in 24 weeks from baseline 7)Study of background factors in cases of attainment and non-attainment of HbA1c <7.0% 8)Change of insulin dosage 9)Changes of DTSQs, DTSQc 10)Changes of weight, BMI
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Study of glycemic control and frequency of hypoglycemia after switching to insulin degludec
20 | years-old | <= |
80 | years-old | >= |
Male and Female
Patients who have received insulin therapy including once-daily-administration of long-acting insulin for more than 12 weeks in addition to diet therapy and exercise therapy, and also fits the following requirement 1)HbA1c<=7.0% 2)Age between 20-80, regardless of sex
1)Patients who take long-acting insulin twice daily 2)Patients in contraindication of degludec 3)Patients who were considered not to be appropriate for administration of degludec by their doctors. 4)Patients who take high dosage of sulfonylurea drug: 3mg or more Glimepiride a day, 5mg or more Glibenclamide a day, 80mg or more Gliclazide a day. 5)Patients who take GLP-1 receptor agonist in combination
30
1st name | |
Middle name | |
Last name | Masato Odawara |
Tokyo Medical University
The Third Department of Internal Medicine(Department of Diabetes, Endocrinology and Metabolism)
Nishi-Shinjuku 6-7-1, Shinjuku-ku, Tokyo
03-3342-6111
naika3@tokyo-med.ac.jp
1st name | |
Middle name | |
Last name | Junpei Shikuma |
Tokyo Medical University
The Third Department of Internal Medicine(Department of Diabetes, Endocrinology and Metabolism)
Nishi-Shinjuku 6-7-1, Shinjuku-ku, Tokyo
03-3342-6111
naika3@tokyo-med.ac.jp
The Third Department of Internal Medicine(Department of Diabetes, Endocrinology and Metabolism),Tokyo Medical University
The Third Department of Internal Medicine(Department of Diabetes, Endocrinology and Metabolism),Tokyo Medical University
Self funding
NO
2013 | Year | 12 | Month | 02 | Day |
Unpublished
Preinitiation
2013 | Year | 11 | Month | 01 | Day |
2013 | Year | 12 | Month | 02 | Day |
2013 | Year | 12 | Month | 02 | Day |
2013 | Year | 12 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014581
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