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

NCT01370005 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 825

Last updated 2016-02-22

Study results available
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Summary

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

Conditions

Interventions

DRUG

Placebo

Placebo matching BI 10773 low dose

DRUG

BI 10773

BI 10773 high dose once daily

DRUG

Placebo

Placebo matching BI 10773 low dose

DRUG

BI 10773

BI 10773 low dose once daily

DRUG

Placebo

Placebo matching BI 10773 high dose

DRUG

Placebo

Placebo matching BI 10773 high dose

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States
  • Canada
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Lebanon
  • Netherlands
  • Norway
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01370005 on ClinicalTrials.gov