NCT02182830|CompletedPhase 3Results

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

A Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of Empagliflozin (10mg, 25mg) Administered Orally, Once Daily Over 24 Weeks in Hypertensive Black/African American Patients With Type 2 Diabetes Mellitus

Boehringer Ingelheim ClinicalTrials.gov

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1 other identifier

1245.29

Study Type

interventional

Target

166

Locations

1 country

Sites

Timeline

RegisteredJul 2014

StartedJul 2014

CompletionMay 2017

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

166

participants targeted

Target at below P25 for phase_3 diabetes-mellitus-type-2

Timeline

Completed

Started Jul 2014

Longer than P75 for phase_3 diabetes-mellitus-type-2

Geographic Reach

1 country

92 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.8 years study duration

First Submitted

Initial submission to the registry

July 3, 2014

Completed

5 days until next milestone

First Posted

Study publicly available on registry

July 8, 2014

Completed

17 days until next milestone

Study Start

First participant enrolled

July 25, 2014

Completed

2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2017

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

July 31, 2018

Completed

Last Updated

July 31, 2018

Status Verified

June 1, 2018

Enrollment Period

2.8 years

First QC Date

July 3, 2014

Results QC Date

May 16, 2018

Last Update Submit

July 4, 2018

Conditions

Diabetes Mellitus, Type 2 Hypertension

Outcome Measures

Primary Outcomes (1)

Change From Baseline in Glycated Haemoglobin (HbA1c) (%) at 24 Weeks
Change from baseline in HbA1c (%) at 24 weeks is presented. The term "baseline" refers to the last observation prior to randomisation of the patient. Means presented are the adjusted means. Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) model is used in the statistical analysis.
baseline and 24 weeks

Secondary Outcomes (10)

Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure (SBP) at Week 12
baseline and 12 weeks
Changes From Baseline in Trough Mean Ambulatory SBP at Week 12
baseline and 12 weeks
Change From Baseline in Body Weight at Week 24
baseline and 24 weeks
Change From Baseline in Trough Seated SBP at Week 12
baseline and 12 weeks
Change From Baseline in Mean 24-hour Ambulatory SBP (mmHg) at Week 24
baseline and 24 weeks
+5 more secondary outcomes