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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2; Hypertension
• Interventions: Drug: Empagliflozin low dose; Drug: placebo; Drug: Empagliflozin high dose

• Registration Number: NCT02182830
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-03
• Study First Submitted QC: 2014-07-03
• Study First Posted: 2014-07-08
• Study Start: 2014-07-25
• Primary Completion: 2017-05-18
• Study Completion: 2017-05-18
• Results First Submitted: 2018-05-16
• Status Verified: 2018-06
• Results First Submitted QC: 2018-07-04
• Last Update Submitted: 2018-07-04
• Results First Posted: 2018-07-31
• Last Update Posted: 2018-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Empagliflozin	Empagliflozin low dose	starting dose 10mg; forced titration after 4 weeks 25mg dose
Placebo	placebo	starting dose 10mg; forced titration after 4 weeks 25mg dose
Empagliflozin	Empagliflozin high dose	starting dose 10mg; forced titration after 4 weeks 25mg dose

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Glycated Haemoglobin (HbA1c) (%) at 24 Weeks	baseline and 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.

Secondary Outcome Measures

Name	Time	Method
Changes From Baseline in Trough Mean Ambulatory SBP at Week 12	baseline and 12 weeks	Changes from baseline in trough mean ambulatory SBP at Week 12 is presented. The term "baseline" refers to the last observation prior to randomisation of the patient.; Means presented are the adjusted means. This is a key secondary endpoint
Change From Baseline in Body Weight at Week 24	baseline and 24 weeks	Changes from baseline in body weight at Week 24 is presented. The term "baseline" refers to the last observation prior to randomisation of the patient.; Means presented are the adjusted means. This is a key secondary endpoint
Change From Baseline in Trough Seated SBP at Week 12	baseline and 12 weeks	Change from baseline in trough seated SBP (mmHg) at Week 12 is presented. The term "baseline" refers to the last observation prior to randomisation of the patient.; Means presented are the adjusted means. This is a key secondary endpoint
Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure (SBP) at Week 12	baseline and 12 weeks	Change from baseline in mean 24-hour ambulatory Systolic blood pressure SBP at Week 12 is presented. The term "baseline" refers to the last observation prior to randomisation of the patient.; Means presented are the adjusted means. This is a key secondary endpoint
Change From Baseline in Mean 24-hour Ambulatory SBP (mmHg) at Week 24	baseline and 24 weeks	Change from baseline in mean 24-hour ambulatory SBP (mmHg) at Week 24 is secondary endpoint. The term "baseline" refers to the last observation prior to randomisation of the patient.; Means presented are the adjusted means.
Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (DBP) at Week 12	baseline and 12 weeks	Change from baseline in mean 24-hour ambulatory DBP (mmHg) at Week 12. The term "baseline" refers to the last observation prior to randomisation of the patient.; Means presented are the adjusted means.
Change From Baseline in Mean 24-hour Ambulatory DBP (mmHg) at Week 24	baseline and 24 weeks	Change from baseline in mean 24-hour ambulatory DBP (mmHg) at Week 24 is secondary endpoint. The term "baseline" refers to the last observation prior to randomisation of the patient.; Means presented are the adjusted means.
Change From Baseline in Trough Seated SBP (mmHg) at Week 24	baseline and 24 weeks	Change from baseline in trough seated SBP (mmHg) at Week 24 is secondary endpoint. The term "baseline" refers to the last observation prior to randomisation of the patient.; Means presented are the adjusted means.
Change From Baseline in Trough Seated DBP (mmHg) at Week 12	baseline and 12 weeks	Change from baseline in trough seated DBP (mmHg) at Week 12 is secondary endpoint. The term "baseline" refers to the last observation prior to randomisation of the patient.; Means presented are the adjusted means.
Change From Baseline in Trough Seated DBP (mmHg) at Week 24	baseline and 24 weeks	Change from baseline in trough seated DBP (mmHg) at Week 24 is secondary endpoint. The term "baseline" refers to the last observation prior to randomisation of the patient.; Means presented are the adjusted means.

Trial Locations

Locations (89)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Clinical Research Advantage, Inc./Rita B. Chuang, MD, LLC; 🇺🇸 Marietta, Georgia, United States

Longwood Research; 🇺🇸 Huntsville, Alabama, United States

Internal Medicine Center, LLC; 🇺🇸 Mobile, Alabama, United States

Mobile Medical and Diagnostic Center; 🇺🇸 Mobile, Alabama, United States

University of South Alabama; 🇺🇸 Mobile, Alabama, United States

Cardiology and Medicine Clinic; 🇺🇸 Little Rock, Arkansas, United States

Larry Watkins, M .D.; 🇺🇸 Little Rock, Arkansas, United States

eStudySite; 🇺🇸 Chula Vista, California, United States

Torrance Clinical Research Institute Inc.; 🇺🇸 Lomita, California, United States

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