Unique ID issued by UMIN | UMIN000021552 |
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Receipt number | R000024664 |
Scientific Title | Open, randomized, active-controlled insulin resistance outcome trial of safety and efficacy with empagliflozin in type 2 diabetic patients |
Date of disclosure of the study information | 2016/03/30 |
Last modified on | 2020/09/23 16:46:34 |
Open, randomized, active-controlled insulin resistance outcome trial of safety and efficacy with empagliflozin in type 2 diabetic patients
Insulin resistance outcomes with empagliflozin in type2 diabetic patients
Open, randomized, active-controlled insulin resistance outcome trial of safety and efficacy with empagliflozin in type 2 diabetic patients
Insulin resistance outcomes with empagliflozin in type2 diabetic patients
Japan |
Type 2 diabetes
Medicine in general | Endocrinology and Metabolism |
Others
NO
Investigation of effects of empagiiflozin on type 2 diabetic patients with insulin resistance
Efficacy
Fasting blood glucose and IRI are set to be measured at baseline, 3, 6, 9, 12 months.
And HOMA-IR will be estimated.
Body mass index (BMI), blood pressure, brain natriuretic peptide (BNP), albumin -creatinine ratio (ACR), lipid and liver function are set to be measured at baseline, 3, 6, 9, 12 months.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Active treatment with empagliflozin 10mg/day for 12 months
Active treatment without all of SGLT-2 inhibition drugs for 12 months
20 | years-old | <= |
75 | years-old | >= |
Male and Female
Type 2 diabetic patients with insulin resistance
1)BMI <20
2)eGFR <30
3)Both of reduced insulin secretion and no use of insulin
4)Having had side effects of another SGLT -2I drugs before
100
1st name | Sachiko |
Middle name | |
Last name | Hattori |
Foundation Health Medicine Association Tohto Clinic
Diabetes Internal Medicine
102-0094
4-1 Kioi-Cho,Chiyoda-Ku,Tokyo 102-0094 Japan
03-3239-0301
s-hattori@kenkoigaku.or.jp
1st name | Sachiko |
Middle name | |
Last name | Hattori |
Foundation Health Medicine Association Tohto Clinic
Diabetes Internal Medicine
102-0094
4-1 Kioi-Cho,Chiyoda-Ku,Tokyo 102-0094 Japan
03-3239-0301
s-hattori@kenkoigaku.or.jp
Diabetes Internal Medicine,Tohto Clinic
None
Self funding
Thoto clinic
4-1 Kioi-cho Chiyoda-ku Tokyo
03-3239-0301
rinri-tohto@kenkoigaku.or.jp
NO
2016 | Year | 03 | Month | 30 | Day |
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6299593/#Sec2title
Published
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6299593/#Sec6title
102
Empagliflozin tended to elicit reductions in BMI, HbA1c, ALT, and gamma-GTP compared with the placebo, but the differences did not reach statistical significance. Levels of LDL-C, HDL-C, and TG were unaltered, increased, and decreased, by EMPA, but the differences were not statistically significant compared with the placebo. Empagliflozin for 12 months notably reduced HOMA-IR, RLP-C, and hsCRP by 43%, 52% and 54%, respectively. SBP and DB were also significantly reduced by EMPA compared with the placebo.
2020 | Year | 09 | Month | 23 | Day |
This single-center, open-label, randomized, prospective study enrolled patients without a history of medication with SGLT2 inhibitors and with HbA1c > 6.2% regardless of diet, exercise, and medical treatment other than SGLT2 inhibitors for at least 12 weeks. They were assessed at our clinic and might have had insulin resistance (BMI > 28 or homeostatic model assessment of insulin resistance [HOMA-IR] > 1.73 or fasting immunoreactive insulin [IRI] > 10 and fasting blood glucose [FBG] < 180). The patients were then allocated to receive EMPA (10 mg; n = 51) or a placebo (n = 51) as an add-on treatment. All patients continued with their administered oral hypoglycemic drugs (sulfonylureas, metformin, or an alpha-glucosidase inhibitor), antihypertensive agents (angiotensin II receptor blockers or calcium channel blockers), and antihyperlipidemic agents (statins or fibrates).
Patients were allocated to receive a placebo (n=51) or EMPA (n=51) as an add-on treatment.
None.
Overnight fasting blood and urine samples were obtained at baseline and after every 3 months of EMPA or placebo administration for 1 year. All biochemical data were obtained at our laboratory, except IRI, remnant-like particle cholesterol (RLP-C), hsCRP and urinary albumin, which were assessed at LSI Medicine Corporation (Tokyo, Japan). We calculated HOMA-IR every 3 months as follows: EMPA was stopped for 72 h until urinary glucose was undetectable and then blood values of fasting glucose and IRI were measured.
Completed
2016 | Year | 02 | Month | 24 | Day |
2016 | Year | 02 | Month | 25 | Day |
2016 | Year | 03 | Month | 30 | Day |
2019 | Year | 03 | Month | 31 | Day |
2016 | Year | 03 | Month | 21 | Day |
2020 | Year | 09 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024664
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