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SGLT-2i and ARB Combination Therapy in Patients With T2DM and Nocturnal Hypertension (SACRA Study)

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ClinicalTrials.gov Identifier: NCT03050229
Recruitment Status : Completed
First Posted : February 10, 2017
Last Update Posted : March 27, 2018
Sponsor:
Collaborators:
Boehringer Ingelheim
Eli Lilly and Company
Information provided by (Responsible Party):
Kazuomi Kario, Jichi Medical University

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
Nocturnal Hypertension T2DM (Type 2 Diabetes Mellitus) Drug: Empagliflozin Drug: Placebo Phase 4

Detailed Description:
The study consists of a 8-week run-in period and a 12-week treatment period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Actual Study Start Date : January 2017
Actual Primary Completion Date : October 2017
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


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 Name: Jardiance

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




Primary Outcome Measures :
  1. Reduction of nocturnal blood pressure measured by ABPM [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Reduction of Blood pressure measured by ABPM -24h Blood Pressure [ Time Frame: 12 weeks ]
  2. Reduction of Blood pressure measured by ABPM -Daytime Blood Pressure [ Time Frame: 12 weeks ]
  3. Reduction of Blood pressure measured by ABPM -Minimum nocturnal Blood Pressure [ Time Frame: 12 weeks ]
  4. Reduction of Blood pressure measured by ABPM -Nocturnal blood pressure variability [ Time Frame: 12 weeks ]
  5. Reduction of Metabolism-related factors -HbA1c [ Time Frame: 12 weeks ]
  6. Reduction of Metabolism-related factors -body weight [ Time Frame: 12 weeks ]
  7. Reduction of Metabolism-related factors -BMI [ Time Frame: 12 weeks ]
  8. Reduction of Metabolism-related factors -lipids [ Time Frame: 12 weeks ]
  9. Reduction of Metabolism-related factors -uric acid [ Time Frame: 12 weeks ]
  10. Reduction of Metabolism-related factors -HOMA-R [ Time Frame: 12 weeks ]
  11. Reduction of Metabolism-related factors -HOMA-beta [ Time Frame: 12 weeks ]
  12. Change in Sleep efficacy -Sleep scale (Athens insomnia scale) [ Time Frame: 12 weeks ]
  13. Change in Sleep efficacy -Frequency of nocturnal awakening [ Time Frame: 12 weeks ]
  14. Change in Sleep efficacy -Frequency of nocturia [ Time Frame: 12 weeks ]
  15. Changes in the measures of circulating volume -Plasma NT-proBNP [ Time Frame: 12 weeks ]
  16. Changes in the measures of circulating volume -ANP [ Time Frame: 12 weeks ]
  17. Changes in the measures of organ damage -Urinary albumin/creatinine excretion ratio [ Time Frame: 12 weeks ]
  18. Changes in the measures of organ damage -Urinary Na/K [ Time Frame: 12 weeks ]
  19. Changes in the measures of organ damage -eGFR [ Time Frame: 12 weeks ]
  20. Changes in the measures of organ damage -cystatinC [ Time Frame: 12 weeks ]
  21. The correlation between blood pressure and blood glucose control [ Time Frame: 12 weeks ]
  22. The correlation between blood pressure and body weight [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050229


Locations
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Japan
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
Sponsors and Collaborators
Jichi Medical University
Boehringer Ingelheim
Eli Lilly and Company
Investigators
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Principal Investigator: Kazuomi Kario, MD Jichi Medical University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kazuomi Kario, Professor & Chairman, Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University
ClinicalTrials.gov Identifier: NCT03050229    
Other Study ID Numbers: 1245-131
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Empagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs