Unique ID issued by UMIN | UMIN000053224 |
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Receipt number | R000060623 |
Scientific Title | Evaluation of the Efficacy and Safety of Basal-Bolus Insulin Therapy combined SGLT2 Inhibitors in Patients with Type 2 Diabetes Mellitus Hospitalized for Hyperglycemia; An open-label prospective randomized trial |
Date of disclosure of the study information | 2023/12/26 |
Last modified on | 2023/12/26 11:51:22 |
Efficacy and Safety of Basal-Bolus Insulin Therapy with SGLT2 Inhibitors in Patients with Type 2 Diabetes Mellitus Hospitalized for Hyperglycemia
Efficacy and Safety of Basal-Bolus Insulin Therapy with SGLT2 Inhibitors in Patients with Type 2 Diabetes Mellitus Hospitalized
Evaluation of the Efficacy and Safety of Basal-Bolus Insulin Therapy combined SGLT2 Inhibitors in Patients with Type 2 Diabetes Mellitus Hospitalized for Hyperglycemia; An open-label prospective randomized trial
Efficacy and Safety of Basal-Bolus Insulin Therapy with SGLT2 Inhibitors in Patients with Type 2 Diabetes Mellitus Hospitalized
Japan |
Type 2 diabetes
Endocrinology and Metabolism |
Others
NO
Evaluation of the Efficacy and Safety of Basal-Bolus Insulin Therapy combined SGLT2 Inhibitors in Patients with Type 2 Diabetes Mellitus Hospitalized for Hyperglycemia
Safety,Efficacy
Percentage of blood glucose 70-180 mg/dl based on continuous blood glucose measurements for 8 days after admission
1) Blood glucose levels measured before each meal + before bedtime
2) Blood glucose variability data by CGM
3) Blood ketone levels
4) Frequency of hypoglycemia
5) Length of hospitalization
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
2
Treatment
Medicine |
Basal-bolus insulin therapy with empagliflozin 10mg
Basal-bolus insulin therapy alone
20 | years-old | <= |
90 | years-old | >= |
Male and Female
1) Untreated patients with an HbA1c > 10%
2) Patients on oral diabetes medications with HbA1c > 8%
3) On once-daily insulin self-injection or once-daily GLP-1 receptor agonist and HbA1c > 8%
3) BMI>18kg/m2
4) Hospitalization for the primary purpose of glycemic control
5) Patients with consent obtained
1) Type 1 diabetes mellitus
2) Frequent insulin injections
3) Pregnancy
4) On SGLT2 inhibitors (washout for at least 1 week is acceptable)
5) DPP4 inhibitor in once-weekly formulation
6) Once-weekly GLP-1RA
7) Undergoing chemotherapy
8) DKA or history of DKA
9) Hyperglycemic coma
10)High-dose steroids (>10 mg PSL equivalent)
36
1st name | Nobutoshi |
Middle name | |
Last name | Fushimi |
Ichinomiyanishi hospital
Department of Endocrinology and Diabetes
4940001
1, Kaimei-hira, Ichinomiya-city, Aichi, JAPAN
0586480077
nobutoshi243@yahoo.co.jp
1st name | Takashi |
Middle name | |
Last name | Terada |
Ichinomiyanishi Hospital
Operations Division
4940001
1, Kaimei-hira, Ichinomiya-city, Aichi, 494-0001, JAPAN
0586480077
n-terada@anzu.or.jp
Ichinomiynishi Hospital
Self funding
Self funding
Ichinomiya Nishi Hospital
1, Kaimei-hira, Ichinomiya-city, Aichi, 494-0001, JAPAN
0586480077
nobutoshi243@yahoo.co.jp
NO
2023 | Year | 12 | Month | 26 | Day |
Unpublished
Enrolling by invitation
2023 | Year | 06 | Month | 01 | Day |
2023 | Year | 12 | Month | 25 | Day |
2023 | Year | 12 | Month | 26 | Day |
2024 | Year | 08 | Month | 01 | Day |
2023 | Year | 12 | Month | 26 | Day |
2023 | Year | 12 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060623
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