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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01370005
First received: June 8, 2011
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Type 2
Hypertension
Drug: Placebo
Drug: BI 10773
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • change of HbA1c from baseline [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • change of mean 24-hour systolic blood pressure from baseline [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change of mean 24-hour diastolic blood pressure from baseline [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with HbA1c <7% [ Time Frame: 12 week ] [ Designated as safety issue: No ]
  • change of fasting plasma glucose from baseline [ Time Frame: 12 week ] [ Designated as safety issue: No ]
  • change of body weight from baseline [ Time Frame: 12 week ] [ Designated as safety issue: No ]
  • change of daytime systolic blood pressure from baseline [ Time Frame: 12 week ] [ Designated as safety issue: No ]
  • change of daytime diastolic blood pressure from baseline [ Time Frame: 12 week ] [ Designated as safety issue: No ]
  • change of nighttime systolic blood pressure from baseline [ Time Frame: 12 week ] [ Designated as safety issue: No ]
  • change of nighttime diastolic blood pressure from baseline [ Time Frame: 12 week ] [ Designated as safety issue: No ]
  • change of trough mean sitting systolic blood pressure from baseline [ Time Frame: 12 week ] [ Designated as safety issue: No ]
  • change of trough mean sitting diastolic blood pressure from baseline [ Time Frame: 12 week ] [ Designated as safety issue: No ]
  • change of orthostatic blood pressure [ Time Frame: 12 week ] [ Designated as safety issue: No ]
  • proportion of patients reaching blood pressure <130/80 mmHg [ Time Frame: 12 week ] [ Designated as safety issue: No ]
  • composite endpoint of the following: change of HbAg1c from baseline > -0.5%, change of systolic blood pressure > -3 mmHg from baseline and change of weight from baseline > -2% [ Time Frame: 12 week ] [ Designated as safety issue: No ]

Enrollment: 825
Study Start Date: June 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 10773 low dose
BI 10773 low dose once daily
Drug: Placebo
Placebo matching BI 10773 low dose
Drug: BI 10773
BI 10773 low dose once daily
Experimental: BI 10773 high dose
BI 10773 high dose once daily
Drug: BI 10773
BI 10773 high dose once daily
Drug: Placebo
Placebo matching BI 10773 high dose
Placebo Comparator: Placebo
Placebo tablets matching BI 10773
Drug: Placebo
Placebo matching BI 10773 low dose
Drug: Placebo
Placebo matching BI 10773 high dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01370005

  Show 120 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01370005     History of Changes
Other Study ID Numbers: 1245.48, 2011-000347-25
Study First Received: June 8, 2011
Last Updated: December 12, 2012
Health Authority: Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Estonia: The State Agency of Medicine
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Lebanon:
Netherlands:
Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014