24 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Black/African American Patients With Type 2 Diabetes Mellitus and Hypertension

Conditions

• Diabetes Mellitus, Type 2
• Hypertension

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Empagliflozin low dose — DRUG
  starting dose 10mg; forced titration after 4 weeks 25mg dose
• placebo — DRUG
  starting dose 10mg; forced titration after 4 weeks 25mg dose
• Empagliflozin high dose — DRUG
  starting dose 10mg; forced titration after 4 weeks 25mg dose

Study Details

This trial is designed to investigate the efficacy and safety of empagliflozin compared with placebo in hypertensive black/African Americans with type 2 Diabetes Mellitus. Since hyperglycaemia and hypertension are key risk factors for both micro- and macrovascular complications, assessment of both glucose and BP lowering effects of empagliflozin in hypertensive African American patients with type 2 Diabetes Mellitus could provide clinically highly relevant, new information for the use of empagliflozin. Essential hypertension is four times more common in African Americans than in Caucasians. One of the risk factors for hypertension is sodium sensitivity and approximately one third of the essential hypertensive population is responsive to sodium intake. There is a higher association of hypertension with sodium sensitivity in African American patients with type 2 Diabetes Mellitus. The treatment duration of this trial (24 weeks) will enable assessment of the clinically relevant endpoint of a decrease in HbA1c, a well accepted measurement of chronic glycaemic control and the key secondary endpoints of decreases in systolic BP (SBP) and diastolic BP (DBP) at 12 and 24 weeks.

Key Dates

Start date

Jul 25, 2014

Status verified

Jun 2018

Primary completion

May 18, 2017

Completion

May 18, 2017

Study Design

Enrollment

166 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Empagliflozin
  starting dose 10mg; forced titration after 4 weeks 25mg dose
• Placebo Comparator: Placebo
  starting dose 10mg; forced titration after 4 weeks 25mg dose

Primary Outcome Measure

Change From Baseline in Glycated Haemoglobin (HbA1c) (%) at 24 Weeks [ Time Frame: baseline and 24 weeks ]

Locations (92)

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