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

Sponsor
Jichi Medical University
Study ID
NCT03050229
Phase
PHASE4
Status
Completed

Conditions

  • Nocturnal Hypertension
  • T2DM (Type 2 Diabetes Mellitus)

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin — DRUG
    Empagliflozin 10mg/day once daily before or after breakfast
  • Placebo — DRUG
    Placebo once daily before or after breakfast

Study Details

To explore the beneficial effects of 'empagliflozin + ARB' in comparison with 'placebo + ARB' on the reduction of nocturnal blood pressure in T2DM with hypertension

Key Dates

Start date
Jan 31, 2017
Status verified
Mar 2018
Primary completion
Oct 31, 2017
Completion
Mar 31, 2018

Study Design

Enrollment
174 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Reduction of nocturnal blood pressure measured by ABPM [ Time Frame: 12 weeks ]

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