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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
| Eli Lilly and Company | INDUSTRY |
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To explore the beneficial effects of 'empagliflozin + ARB' in comparison with 'placebo + ARB' on the reduction of nocturnal blood pressure in T2DM with hypertension
The study consists of a 8-week run-in period and a 12-week treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empagliflozin | Experimental | Empagliflozin 10mg/day is administrated orally before or after breakfast for 12 weeks while continuing the existing treatment for hypertension (include AngiotensinII Receptor Blocker [ARB]) and diabetes. |
|
| Placebo | Placebo Comparator | Placebo is administrated orally before or after breakfast for 12 weeks while continuing the existing treatment for hypertension (include AngiotensinII Receptor Blocker [ARB]) and diabetes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin | Drug | Empagliflozin 10mg/day once daily before or after breakfast |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of nocturnal blood pressure measured by ABPM | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of Blood pressure measured by ABPM -24h Blood Pressure | 12 weeks | |
| Reduction of Blood pressure measured by ABPM -Daytime Blood Pressure | 12 weeks | |
| Reduction of Blood pressure measured by ABPM -Minimum nocturnal Blood Pressure |
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Inclusion Criteria:
Patients who meet the following criteria at the start of treatment are eligible for the study:
Exclusion Criteria:
Patients who meet any of the following criteria are not eligible for the study:
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| Name | Affiliation | Role |
|---|---|---|
| Kazuomi Kario, MD | Jichi Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fukuoka University Chikushi Hospital | Fukuoka | Japan | ||||
| Kotake Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30586745 | Derived | Kario K, Okada K, Kato M, Nishizawa M, Yoshida T, Asano T, Uchiyama K, Niijima Y, Katsuya T, Urata H, Osuga JI, Fujiwara T, Yamazaki S, Tomitani N, Kanegae H. Twenty-Four-Hour Blood Pressure-Lowering Effect of a Sodium-Glucose Cotransporter 2 Inhibitor in Patients With Diabetes and Uncontrolled Nocturnal Hypertension: Results From the Randomized, Placebo-Controlled SACRA Study. Circulation. 2019 Apr 30;139(18):2089-2097. doi: 10.1161/CIRCULATIONAHA.118.037076. Epub 2018 Nov 29. |
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| Placebo | Drug | Placebo once daily before or after breakfast |
|
| 12 weeks |
| Reduction of Blood pressure measured by ABPM -Nocturnal blood pressure variability | 12 weeks |
| Reduction of Metabolism-related factors -HbA1c | 12 weeks |
| Reduction of Metabolism-related factors -body weight | 12 weeks |
| Reduction of Metabolism-related factors -BMI | 12 weeks |
| Reduction of Metabolism-related factors -lipids | 12 weeks |
| Reduction of Metabolism-related factors -uric acid | 12 weeks |
| Reduction of Metabolism-related factors -HOMA-R | 12 weeks |
| Reduction of Metabolism-related factors -HOMA-beta | 12 weeks |
| Change in Sleep efficacy -Sleep scale (Athens insomnia scale) | 12 weeks |
| Change in Sleep efficacy -Frequency of nocturnal awakening | 12 weeks |
| Change in Sleep efficacy -Frequency of nocturia | 12 weeks |
| Changes in the measures of circulating volume -Plasma NT-proBNP | 12 weeks |
| Changes in the measures of circulating volume -ANP | 12 weeks |
| Changes in the measures of organ damage -Urinary albumin/creatinine excretion ratio | 12 weeks |
| Changes in the measures of organ damage -Urinary Na/K | 12 weeks |
| Changes in the measures of organ damage -eGFR | 12 weeks |
| Changes in the measures of organ damage -cystatinC | 12 weeks |
| The correlation between blood pressure and blood glucose control | 12 weeks |
| The correlation between blood pressure and body weight | 12 weeks |
| Fukuoka |
| Japan |
| Onga Hospital | Fukuoka | Japan |
| Ishiguro Clinic | Gifu | Japan |
| Higashiagatsuma-machi National Health Insurance Clinic | Gunma | Japan |
| Katsuya Iin | Hyōgo | Japan |
| Minamisanriku Hospital | Miyagi | Japan |
| Shibuya Clinic | Saitama | Japan |
| International University of Health and Welfare Hospital | Tochigi | Japan |
| Jichi Medical University hospital | Tochigi | Japan |
| Utsunomiya higashi hospital | Tochigi | Japan |
| Kato Clinic | Tokyo | Japan |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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