Unique ID issued by UMIN | UMIN000018997 |
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Receipt number | R000021333 |
Scientific Title | The Sodium glucose transporter 2 inhibitor with acute insulin treatment for controlling severe hyperglycemia in patients with type 2 Diabetes mellitus |
Date of disclosure of the study information | 2015/09/13 |
Last modified on | 2016/09/12 15:00:19 |
The Sodium glucose transporter 2 inhibitor with acute insulin treatment for controlling severe hyperglycemia in patients with type 2 Diabetes mellitus
The Sodium glucose transporter 2 inhibitor with acute insulin treatment for controlling severe hyperglycemia in patients with type 2 Diabetes mellitus
The Sodium glucose transporter 2 inhibitor with acute insulin treatment for controlling severe hyperglycemia in patients with type 2 Diabetes mellitus
The Sodium glucose transporter 2 inhibitor with acute insulin treatment for controlling severe hyperglycemia in patients with type 2 Diabetes mellitus
Japan |
type2 diabetes mellitus
Endocrinology and Metabolism |
Others
NO
To study the effectiveness and safety of the SGLT2 inhibitor with acute insulin treatment in type2 diabetes mellitus patient who need insulin to resolve severe-hyperglycemia.
Safety,Efficacy
1.the dose of insulin and treatment period to manage hyperglycemia
2.measurement of energy expenditure and respiratory quotient by using the indirectcalorimetry
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
2
Treatment
Medicine |
insulin treatment adding 5mg Dapagliflozin for 1 week.the attending physician dose of insuline adjusted according to the algorithm
insulin treatment not adding
Dapagliflozin for 1 week.
the attending physician dose of insuline adjusted according to the algorithm
20 | years-old | <= |
80 | years-old | >= |
Male and Female
(1) Patients with HbA1c over 10%
(2) Patients who does not use human GLP-1 analog or insulin
(3) Adalts who are 20 years or older
(4) Patients who can understand consent brief and other explanation documents having the ability of the agreement about participation in this examination
(1) Type 1 diabetes mellitus patients or secondary diabetic mellitus
(2) Patients who had myocardial infarction within 3 months, or obvious heart failure case
(3) Patients who had the past of hypersensitivity for the used drug
(4) Patients with diabetic ketoacidosis or diabetic coma or risk of diabetic coma
(5) Patients with severe liver disease
(6) Patients with severe renal disease
(7) Patients with severe pancreas disease
(8) Patients with hemoglobin (Hb) less than 11 g/dL
(9) Patient during cancer treatment
(10) Patients that the number of the platelets is less than 100,000 /mm3
(11) Patients with high diabetic neuropathy
(12) Patients having a proliferative retinopathy
(13) Patients with a serious infectious disease or a serious injury
(14) Excessive common custom drinker
(15) A pregnant woman or the woman who may be pregnant
(16) In addition, the patient who judged inappropriate by an attendant physician
20
1st name | |
Middle name | |
Last name | Uchino hiroshi |
Toho University School of Medicine
Divsion of diabetes, metabolism and endocrinology
6-11-1 Omori-nishi,Ota-ku,Tokyo 143-8541,Japan
03-3762-4151
h.uchino@med.toho-u.ac.jp
1st name | |
Middle name | |
Last name | Uchino hiroshi |
Toho University School of Medicine
Divsion of diabetes, metabolism and endocrinology
6-11-1 Omori-nishi,Ota-ku,Tokyo 143-8541,Japan
03-3762-4151
h.uchino@med.toho-u.ac.jp
Toho University School of Medicine,Divsion of diabetes, metabolism and endocrinology
Toho University School of Medicine
Self funding
NO
2015 | Year | 09 | Month | 13 | Day |
Unpublished
Completed
2014 | Year | 08 | Month | 01 | Day |
2014 | Year | 10 | Month | 08 | Day |
2015 | Year | 11 | Month | 24 | Day |
2016 | Year | 06 | Month | 13 | Day |
2016 | Year | 06 | Month | 13 | Day |
2016 | Year | 06 | Month | 13 | Day |
2015 | Year | 09 | Month | 13 | Day |
2016 | Year | 09 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021333
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