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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: May 16, 2014
Last verified: May 2014
  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:
  • HbA1c Change From Baseline [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in HbA1c after 12 weeks of treatment.

  • Mean 24-hour Systolic Blood Pressure Change From Baseline [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline of mean 24-hour systolic blood pressure (SBP).


Secondary Outcome Measures:
  • Mean 24-hour Diastolic Blood Pressure Change From Baseline [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in mean 24-hour diastolic blood pressure (DBP) after 12 weeks.

  • Proportion of Patients With HbA1c <7% [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Proportion of patients with HbA1c <7% after 12 weeks.

  • Fasting Plasma Glucose (FPG) Change From Baseline [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in FPG after 12 weeks of treatment.

  • Body Weight Change From Baseline [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in body weight after 12 weeks of treatment.

  • Daytime Mean Systolic Blood Pressure (SBP) Change From Baseline [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in daytime mean SBP after 12 weeks of treatment.

  • Daytime Mean Diastolic Blood Pressure (DBP) Change From Baseline [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in daytime mean DBP after 12 weeks of treatment.

  • Nighttime Mean Systolic Blood Pressure (SBP) Change From Baseline [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in nighttime mean SBP after 12 weeks of treatment.

  • Nighttime Mean Diastolic Blood Pressure (DBP) Change From Baseline [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in nighttime mean DBP after 12 weeks of treatment.

  • Trough Mean Seated Systolic Blood Pressure (SBP) Change From Baseline [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in Trough Mean Seated SBP after 12 weeks of treatment.

  • Trough Mean Seated Diastolic Blood Pressure (DBP) Change From Baseline [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in trough mean seated DBP after 12 weeks of treatment.

  • Proportion of Patients Reaching Blood Pressure <130/80 mmHg [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Proportion of patients reaching blood pressure <130/80 mmHg after 12 weeks of treatment

  • Composite Endpoint of Change From Baseline of HbA1c, Systolic Blood Pressure and Body Weight [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    A composite endpoint of the following conditions at week 12 compared to baseline (all 3 fulfilled): reduction of HbA1c from baseline of at least 0.5%, reduction of systolic blood pressure > 3 mmHg from baseline and reduction of weight from baseline > 2%

  • Orthostatic Blood Pressure [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Orthostatic blood pressure (BP) at baseline and after 12 weeks of treatment.


Other Outcome Measures:
  • Confirmed Hypoglycaemic Adverse Events [ Time Frame: From drug administration until last drug administration plus seven days, up to 171 days ] [ Designated as safety issue: No ]
    Number of participants with confirmed hypoglycaemic adverse events


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional 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
Results First Received: May 16, 2014
Last Updated: May 16, 2014
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
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014