Unique ID issued by UMIN | UMIN000037941 |
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Receipt number | R000043247 |
Scientific Title | Correlation between insulin albumin and free fatty acids of insulin glargine 300 U/mL and insulin degludec in patients with type 2 diabetes |
Date of disclosure of the study information | 2019/10/01 |
Last modified on | 2019/09/05 15:58:22 |
Correlation between insulin albumin and free fatty acids of insulin glargine 300 U/mL and insulin degludec in patients with type 2 diabetes
Correlation between insulin albumin and free fatty acids of insulin glargine 300 U/mL and insulin degludec in patients with type 2 diabetes
Correlation between insulin albumin and free fatty acids of insulin glargine 300 U/mL and insulin degludec in patients with type 2 diabetes
Correlation between insulin albumin and free fatty acids of insulin glargine 300 U/mL and insulin degludec in patients with type 2 diabetes
Japan |
type 2 diabetes
Endocrinology and Metabolism |
Others
NO
To evaluate the relationship between serum albumin levels and free fatty acids in patients with type 2 diabetes undergoing Basal Supported Oral Therapy (BOT) with insulin glargine 300 U/mL (Gla300) and insulin degludec (Deg).
Safety,Efficacy
Correlation between blood glucose level, serum albumin level and free fatty acid in BOT
Time range of blood glucose level less than 70mg/dl (hypoglycemic range), blood glucose level 180mg/dl or higher (hyperglycemic range), blood glucose level 70-179mg/dl (normal range), blood glucose level less than 54 mg/dl (severe hypoglycemia range), nocturnal hypoglycemia (0: 00-5: 59, less than 70 mg / dl) in 3 days FGM, severe hypoglycemia (diabetic coma or pre-coma, convulsions requiring third-party assistance), mean blood glucose level, standard deviation value, coefficient of variation value, daily fluctuation, M value, mean amplitude of glycemic excursions, changes in the dose of insulin
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Gla300-Deg
Deg-Gla300
20 | years-old | <= |
80 | years-old | > |
Male and Female
1. Patients who have been diagnosed with type 2 diabetes for more than 1 year before the start of the study and have been treated with oral hypoglycemic drugs and/or long-acting insulin (excluding Gla300 and Deg) for more than 6 months before screening
2. Patients of glycated hemoglobin (HbA1c) levels 7.0% or more and less than 11.0%
1. Patients with a history of severe ketosis, diabetic coma or precoma within 6 weeks
2. Patients who developed severe hypoglycemia (diabetic coma or precoma, convulsions requiring third party assistance) within 6 weeks
3. Patients with severe renal dysfunction (eGFR less than 30mL/min/1.73m2 or serum creatinine level above 2.0mg/dL) or endstage renal failure patients on dialysis
4. Patients with proliferative retinopathy (however, patients who have undergone photocoagulation and have stable symptoms can be included)
5. Patients with a history of severe gastrointestinal tract surgery
6. Pregnant women or women who may be pregnant and breastfeeding patients
7. Patients with severe infections, before and after surgery, and severe trauma
8. Patients receiving systemic corticosteroids
9. Patients with severe liver dysfunction (AST or ALT higher than 100U/l)
10. Patients with a history of allergies to the drug to be used for research
11. Patients with malignant tumor or history of malignant tumor
12. Other patients judged by the investigator as inappropriate as subjects
24
1st name | Yasuro |
Middle name | |
Last name | Kumeda |
Minami Osaka Hospital
Internal medicine
559-0012
1-18-18, Higashikagaya, Suminoe-ku, Osaka, 559-0012, Japan
0666850221
y.kawaguchi@minamiosaka.com
1st name | Yuji |
Middle name | |
Last name | Kawaguchi |
Minami Osaka Hospital
Internal medicine
559-0012
1-18-18, Higashikagaya, Suminoe-ku, Osaka, 559-0012, Japan
0666850221
y.kawaguchi@minamiosaka.com
Minami Osaka Hospital
Minami Osaka Hospital
Self funding
Minami Osaka Hospital
1-18-18, Higashikagaya, Suminoe-ku, Osaka, 559-0012, Japan
0666850221
y.kawaguchi@minamiosaka.com
NO
2019 | Year | 10 | Month | 01 | Day |
Unpublished
Preinitiation
2019 | Year | 09 | Month | 05 | Day |
2019 | Year | 10 | Month | 01 | Day |
2020 | Year | 09 | Month | 30 | Day |
2019 | Year | 09 | Month | 05 | Day |
2019 | Year | 09 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043247
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