Unique ID issued by UMIN | UMIN000011827 |
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Receipt number | R000013824 |
Scientific Title | Insulin Deguldec versus Glargine Once in Tochigi |
Date of disclosure of the study information | 2013/09/20 |
Last modified on | 2019/09/25 12:51:05 |
Insulin Deguldec versus Glargine Once in Tochigi
I'd Got Trial
Insulin Deguldec versus Glargine Once in Tochigi
I'd Got Trial
Japan |
Type 2 diabetes
Endocrinology and Metabolism |
Others
NO
To determine whether insulin deguldec is noninferior to insulin glargine with respect to glycemic control in patients with type 2 diabetes who have inadequate glycemic control despite oral therapy
To assess the effects of insulin degludec on fasting plasma glucose and glycemic variability in individuals with type 2 diabetes
Safety,Efficacy
Confirmatory
Phase IV
The change from baseline in
HbA1c after 24 weeks of treatment.
Standard deviation (SD) of fasting plasma glucose between 8- and 12-week or 20- and 24-week after treatment
Frequencies of all hypoglycemic episodes
Frequencies of nocturnal hypoglycemic episodes during 0:01 and 5:59 AM
Plasma 1, 5 anhydro-D-glucitol
7 points plasma glucose (Daily profile)
Assessment of QOL evaluated by DTR-QOL
Dosage of insulin
Changes in body weight
Urinary 8 iso-prostane
Interventional
Parallel
Randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
Insulin degludec arm
Starting dose 0.1U/Kg/Day
Once daily before breakfast
Duration: 24 weeks
Insulin titration: Treat to target (FPG less than 110 mg/dl)
Insulin glargine arm
Starting dose 0.1U/Kg/Day
Once daily before breakfast
Duration: 24 weeks
Insulin titration: Treat to target (FPG less than 110 mg/dl)
18 | years-old | <= |
Not applicable |
Male and Female
Patients with type 2 diabetes
Patients with insulin naive
Patients who have received oral anti-diabetic drugs more than 3 months
HbA1c values between 7.0 and 10.4%
Body mass index (BMI) less than 40.0
Patients who gave written informed consent
Patients who have experienced severe diabetic ketosis, diabetic coma, or past history of pre-coma prior to 6 months
Female patients who have pregnancy or possibilty of pregnancy, or are under lactation
Patients who had past history of hypersensitivity or allergic reaction to insulin degludec or glargine
80
1st name | Yoshimasa |
Middle name | |
Last name | Aso |
Dokkyo Medical University Hospital
Endocrinology and Metabolism
321-0293
880 Kita-Kobayashi, Mibu, Shimotsuga, Tochigi, Japan
0282-86-1111
yaso@dokkyomed.ac.jp
1st name | Kunihiro |
Middle name | |
Last name | Suzuki |
Dokkyo Medical University Hospital
Endocrinology and Metabolism
321-0293
880 Kita-Kobayashi, Mibu, Shimotsuga, Tochigi, Japan
0282-86-1111
kuni-s@dokkyomed.ac.jp
Dokkyo Medical University
Dokkyo Medical University
Other
Dokkyo Medical University
880 Kita-Kobayashi, Mibu, Shimotsuga, Tochigi, Japan
0282-86-1111
yaso@dokkyomed.ac.jp
NO
2013 | Year | 09 | Month | 20 | Day |
Unpublished
Open public recruiting
2013 | Year | 09 | Month | 11 | Day |
2013 | Year | 09 | Month | 25 | Day |
2013 | Year | 10 | Month | 01 | Day |
2019 | Year | 03 | Month | 26 | Day |
2019 | Year | 03 | Month | 26 | Day |
2013 | Year | 09 | Month | 20 | Day |
2019 | Year | 09 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013824
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