12 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Patients With Type 2 Diabetes Mellitus

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01370005
• Date of registration: 08/06/2011
• Prospective Registration: No
• Primary sponsor: Boehringer Ingelheim
• Public title: 12 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Patients With Type 2 Diabetes Mellitus
• Scientific title: A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg, 25 mg) Administered Orally, Once Daily Over 12 Weeks in Hypertensive Patients With Type 2 Diabetes Mellitus
• Date of first enrolment: June 2011
• Target sample size: 825
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01370005
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, India, Lebanon, Netherlands, Norway, Sweden, United States

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion criteria

Inclusion criteria:

1. Patients >=18 years with type 2 diabetes

2. HbA1c of >= 7.0% (53 mmol/mol) and =< 10% (86 mmol/mol)

3. Mean seated systolic blood pressure 130-159 mmHg and diastolic blood pressure 80-99
mmHg

Exclusion criteria:

1. Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an
overnight fast before randomization

2. Known or suspected secondary hypertension

3. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or
transient ischemic attack within 3 months prior to informed consent



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hypertension

Diabetes Mellitus, Type 2

Intervention(s)

Drug: BI 10773

Drug: Placebo

Primary Outcome(s)

Mean 24-hour Systolic Blood Pressure Change From Baseline [Time Frame: Baseline and 12 weeks]

HbA1c Change From Baseline [Time Frame: Baseline and 12 weeks]

Secondary Outcome(s)

Daytime Mean Systolic Blood Pressure (SBP) Change From Baseline [Time Frame: Baseline and 12 weeks]

Fasting Plasma Glucose (FPG) Change From Baseline [Time Frame: Baseline and 12 weeks]

Mean 24-hour Diastolic Blood Pressure Change From Baseline [Time Frame: Baseline and 12 weeks]

Orthostatic Blood Pressure [Time Frame: Baseline and 12 weeks]

Composite Endpoint of Change From Baseline of HbA1c, Systolic Blood Pressure and Body Weight [Time Frame: Baseline and 12 weeks]

Nighttime Mean Diastolic Blood Pressure (DBP) Change From Baseline [Time Frame: Baseline and 12 weeks]

Nighttime Mean Systolic Blood Pressure (SBP) Change From Baseline [Time Frame: Baseline and 12 weeks]

Daytime Mean Diastolic Blood Pressure (DBP) Change From Baseline [Time Frame: Baseline and 12 weeks]

Proportion of Patients With HbA1c <7% [Time Frame: Baseline and 12 weeks]

Body Weight Change From Baseline [Time Frame: Baseline and 12 weeks]

Trough Mean Seated Systolic Blood Pressure (SBP) Change From Baseline [Time Frame: Baseline and 12 weeks]

Trough Mean Seated Diastolic Blood Pressure (DBP) Change From Baseline [Time Frame: Baseline and 12 weeks]

Proportion of Patients Reaching Blood Pressure <130/80 mmHg [Time Frame: Baseline and 12 weeks]

Secondary ID(s)

1245.48

2011-000347-25

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Eli Lilly and Company

Results

• Results available: Yes
• Date Posted: 17/06/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01370005