SGLT-2i and ARB Combination Therapy in Patients With T2DM and Nocturnal Hypertension (SACRA Study)
Study Details
Study Description
Brief Summary
To explore the beneficial effects of 'empagliflozin + ARB' in comparison with 'placebo + ARB' on the reduction of nocturnal blood pressure in T2DM with hypertension
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
The study consists of a 8-week run-in period and a 12-week treatment period.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Empagliflozin 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. |
Drug: Empagliflozin
Empagliflozin 10mg/day once daily before or after breakfast
Other Names:
|
| Placebo Comparator: Placebo 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. |
Drug: Placebo
Placebo once daily before or after breakfast
|
Outcome Measures
Primary Outcome Measures
- Reduction of nocturnal blood pressure measured by ABPM [12 weeks]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
Patients who meet the following criteria at the start of treatment are eligible for the study:
-
Receiving stable treatment with anti-hypertensive including ARB for at least 8 weeks at baseline (0W).
-
Receiving stable anti-diabetic treatment with/without anti-diabetics for at least 8 weeks at baseline (0W).
-
HbA1c>=6.0%, <10%
-
Seated office SBP 130-159mmHg or DBP 80-99mmHg
-
Nocturnal hypertension (SBP>=115 mmHg) as measured by Home BP during 5days before baseline (0W).
-
Age>=20
Exclusion Criteria:
Patients who meet any of the following criteria are not eligible for the study:
-
History of hypersensitivity to empagliflozin
-
Breast-feeding, pregnant, possibly pregnant, or plan to become pregnant
-
Treated with insulin or SU
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With renal dysfunction (eGFR<45mL/min/1.73m2)
-
With liver dysfunction (AST or ALT is 3 times higher than reference value)
-
Hypotension (systolic blood pressure < 90 mmHg)
-
With pituitary gland dysfunction or adrenal gland dysfunction
-
Heart failure patients whose NYHA class is IV
-
Deemed ineligible for the study due to another reason by investigator
-
History of diabetic ketoacidosis or diabetic come within 3 months before enrollment
-
History of Acute myocardial infarction, unstable angina, cerebrovascular disease, or transient ischemic attack within 3 months before enrollment
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Patients who have undergone percutaneous transluminal coronary angioplasty (PCI) or coronary artery bypass graftin (CABG) within 3 months before enrollment
-
Patients received SGLT2 inhibitor within 8 weeks before enrollment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fukuoka University Chikushi Hospital | Fukuoka | Japan | ||
| 2 | Kotake Hospital | Fukuoka | Japan | ||
| 3 | Onga Hospital | Fukuoka | Japan | ||
| 4 | Ishiguro Clinic | Gifu | Japan | ||
| 5 | Higashiagatsuma-machi National Health Insurance Clinic | Gunma | Japan | ||
| 6 | Katsuya Iin | Hyogo | Japan | ||
| 7 | Minamisanriku Hospital | Miyagi | Japan | ||
| 8 | Shibuya Clinic | Saitama | Japan | ||
| 9 | International University of Health and Welfare Hospital | Tochigi | Japan | ||
| 10 | Jichi Medical University hospital | Tochigi | Japan | ||
| 11 | Utsunomiya higashi hospital | Tochigi | Japan | ||
| 12 | Kato Clinic | Tokyo | Japan |
Sponsors and Collaborators
- Jichi Medical University
- Boehringer Ingelheim
- Eli Lilly and Company
Investigators
- Principal Investigator: Kazuomi Kario, MD, Jichi Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1245-131