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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
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A multicenter, open-label, single-arm study with regard to the efficacy and safety of empagliflozin in patients with refractory diabetes mellitus with insulin resistance
To evaluate the clinical efficacy of a treatment with empagliflozin in refractory diabetes mellitus patients with insulin resistance (insulin resistance syndrome, lipoatrophic diabetes mellitus) by using the HbA1c change at Week 24 of treatment from baseline
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment of empagliflozin | Experimental | Empagliflozin 10 mg is to be continuously administered once daily for 12 weeks. Measure an HbA1c level after 12 weeks and determine the dose (Week 13 to Week 24). In case of <7.0%, 10 mg will be continued: in case of >=7.0%, it will be increased to 25 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin Tablets | Drug | The administration is oral administration with water before or after breakfast. |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c change at Week 24 of the treatment from baseline | With regard to the HbA1c change at Week 24 of the treatment from baseline, changes will be shown by patient, as well as summarizing with the size of sample, mean, standard deviation, minimum, median, and maximum. | at Week 24 of the treatment from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c change rate at Week 24 of the treatment from baseline | With regard to the HbA1c change rate at Week 24 of the treatment from baseline, change rates will be shown by patient, as well as summarizing with the size of sample, mean, standard deviation, minimum, median, and maximum. | at Week 24 of the treatment from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wataru Ogawa | Kobe University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kobe University Hospital | Kobe | Hyōgo | 650-0017 | Japan | ||
| Tohoku University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38216831 | Derived | Hirota Y, Kakei Y, Imai J, Katagiri H, Ebihara K, Wada J, Suzuki J, Urakami T, Omori T, Ogawa W. A Multicenter, Open-Label, Single-Arm Trial of the Efficacy and Safety of Empagliflozin Treatment for Refractory Diabetes Mellitus with Insulin Resistance (EMPIRE-01). Diabetes Ther. 2024 Feb;15(2):533-545. doi: 10.1007/s13300-023-01526-x. Epub 2024 Jan 13. |
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| HbA1c change at Week 12 of the treatment from baseline |
With regard to the HbA1c change at Week 12 of the treatment from baseline, changes will be shown by patient, as well as summarizing with the size of sample, mean, standard deviation, minimum, median, and maximum. |
| at Week 12 of the treatment from baseline |
| HbA1c over time | The HbA1c level at measurement time point is tabulated by patient, as well as plotting the HbA1c level over time by line graph. In addition, the mean, standard deviation, interquartile range, minimum, median, and maximum of HbA1c at each time point will be calculated and tabulated, as well as displaying the mean at each measurement time point with error bar of standard deviation by line graph. | at Week 24 of the treatment from baseline |
| Fasting plasma glucose (FPG) over time | The FPG level at measurement time point is tabulated by patient, as well as plotting the FPG level over time by line graph. In addition, the mean, standard deviation, interquartile range, minimum, median, and maximum of FPG at each time point will be calculated and tabulated, as well as displaying the mean at each measurement time point with error bar of standard deviation by line graph. | at Week 24 of the treatment from baseline |
| FPG change at Week 24 of the treatment from baseline | With regard to the FPG change at Week 24 of the treatment from baseline, changes will be shown by patient, as well as summarizing with the size of sample, mean, standard deviation, minimum, median, and maximum. | at Week 24 of the treatment from baseline |
| Change of insulin dose | The insulin dose of each patient will be tabulated by time point. | at Week 24 of the treatment from baseline |
| Postprandial glucose for 2 hours over time | The postprandial glucose for 2 hours at measurement time point is tabulated by patient, and the glucose level over time is plotted by line graph. In addition, the mean, standard deviation, interquartile range, minimum, median, and maximum of postprandial glucose for 2 hours at each time point will be tabulated, and the mean at each measurement time point with an error bar of standard deviation will be displayed by line graph. | 2 Weeks from Day0 and Day140 |
| Sendai |
| Miyagi |
| 980-8574 |
| Japan |
| Jichi Medical University Hospital | Shimotsuke | Tochigi | 329-0498 | Japan |
| NIhon University Hospital | Chiyoda-ku | Tokyo | 101-8309 | Japan |
| Okayama University Hospital | Okayama | 700-8558 | Japan |
| ID | Term |
|---|---|
| C562710 | Diabetes Mellitus, Insulin-Resistant, with Acanthosis Nigricans |
| D003923 | Diabetes Mellitus, Lipoatrophic |
| D024821 | Metabolic Syndrome |
| D007333 | Insulin Resistance |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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