| Trial ID: | L2663 |
| Source ID: | NCT03050229
|
| Associated Drug: |
Empagliflozin
|
| Title: |
SGLT-2i and ARB Combination Therapy in Patients With T2DM and Nocturnal Hypertension (SACRA Study)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Nocturnal Hypertension|T2DM (Type 2 Diabetes Mellitus)
|
| Interventions: |
DRUG: Empagliflozin|DRUG: Placebo
|
| Outcome Measures: |
Primary: Reduction of nocturnal blood pressure measured by ABPM, 12 weeks | Secondary: 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, 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
|
| Sponsor/Collaborators: |
Sponsor: Jichi Medical University | Collaborators: Boehringer Ingelheim|Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
174
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2017-01
|
| Completion Date: |
2018-03
|
| Results First Posted: |
|
| Last Update Posted: |
2018-03-27
|
| Locations: |
Fukuoka University Chikushi Hospital, Fukuoka, Japan|Kotake Hospital, Fukuoka, Japan|Onga Hospital, Fukuoka, Japan|Ishiguro Clinic, Gifu, Japan|Higashiagatsuma-machi National Health Insurance Clinic, Gunma, Japan|Katsuya Iin, Hyogo, 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
|
| URL: |
https://clinicaltrials.gov/show/NCT03050229
|
