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

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Hypertension; Diabetes Mellitus, Type 2

Treatments: Drug: BI 10773; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01370005

2011-000347-25 (EudraCT Number)

1245.48

Details and patient eligibility

About

This trial will evaluate safety and efficacy of BI 10773 in hypertensive patients with type 2 diabetes. Since hyperglycaemia and hypertension are key risk factors for both micro- and macrovascular complications, assessment of both glucose and blood pressure lowering effects of BI 10773 in hypertensive patients with type 2 diabetes could provide clinically highly relevant, new information for the use of BI 10773

Enrollment: 825 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

825 participants in 3 patient groups, including a placebo group

BI 10773 low dose

Experimental group

Description:

BI 10773 low dose once daily

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: BI 10773

Drug: BI 10773

BI 10773 high dose

Experimental group

Description:

BI 10773 high dose once daily

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: BI 10773

Drug: BI 10773

Placebo

Placebo Comparator group

Description:

Placebo tablets matching BI 10773

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo