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

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:

MedlinePlus related topics: Diabetes Diabetes Type 2 High Blood Pressure

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

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:

Patients >=18 years with type 2 diabetes
HbA1c of >= 7.0% (53 mmol/mol) and =< 10% (86 mmol/mol)
Mean seated systolic blood pressure 130-159 mmHg and diastolic blood pressure 80-99 mmHg

Exclusion criteria:

Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast before randomization
Known or suspected secondary hypertension
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 Pharmaceuticals

Eli Lilly and Company

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim Pharmaceuticals
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 May 16, 2013