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

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ClinicalTrials.gov Identifier: NCT01370005
Recruitment Status : Completed
First Posted : June 9, 2011
Results First Posted : June 17, 2014
Last Update Posted : February 22, 2016
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Hypertension Drug: Placebo Drug: BI 10773 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 825 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : June 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. HbA1c Change From Baseline [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in HbA1c after 12 weeks of treatment.

  2. Mean 24-hour Systolic Blood Pressure Change From Baseline [ Time Frame: Baseline and 12 weeks ]
    Change from baseline of mean 24-hour systolic blood pressure (SBP).


Secondary Outcome Measures :
  1. Mean 24-hour Diastolic Blood Pressure Change From Baseline [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in mean 24-hour diastolic blood pressure (DBP) after 12 weeks.

  2. Proportion of Patients With HbA1c <7% [ Time Frame: Baseline and 12 weeks ]
    Proportion of patients with HbA1c <7% after 12 weeks.

  3. Fasting Plasma Glucose (FPG) Change From Baseline [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in FPG after 12 weeks of treatment.

  4. Body Weight Change From Baseline [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in body weight after 12 weeks of treatment.

  5. Daytime Mean Systolic Blood Pressure (SBP) Change From Baseline [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in daytime mean SBP after 12 weeks of treatment.

  6. Daytime Mean Diastolic Blood Pressure (DBP) Change From Baseline [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in daytime mean DBP after 12 weeks of treatment.

  7. Nighttime Mean Systolic Blood Pressure (SBP) Change From Baseline [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in nighttime mean SBP after 12 weeks of treatment.

  8. Nighttime Mean Diastolic Blood Pressure (DBP) Change From Baseline [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in nighttime mean DBP after 12 weeks of treatment.

  9. Trough Mean Seated Systolic Blood Pressure (SBP) Change From Baseline [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in Trough Mean Seated SBP after 12 weeks of treatment.

  10. Trough Mean Seated Diastolic Blood Pressure (DBP) Change From Baseline [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in trough mean seated DBP after 12 weeks of treatment.

  11. Proportion of Patients Reaching Blood Pressure <130/80 mmHg [ Time Frame: Baseline and 12 weeks ]
    Proportion of patients reaching blood pressure <130/80 mmHg after 12 weeks of treatment

  12. Composite Endpoint of Change From Baseline of HbA1c, Systolic Blood Pressure and Body Weight [ Time Frame: Baseline and 12 weeks ]
    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%

  13. Orthostatic Blood Pressure [ Time Frame: Baseline and 12 weeks ]
    Orthostatic blood pressure (BP) at baseline and after 12 weeks of treatment.


Other Outcome Measures:
  1. Confirmed Hypoglycaemic Adverse Events [ Time Frame: From drug administration until last drug administration plus seven days, up to 171 days ]
    Number of participants with confirmed hypoglycaemic adverse events


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01370005


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01370005    
Other Study ID Numbers: 1245.48
2011-000347-25 ( EudraCT Number: EudraCT )
First Posted: June 9, 2011    Key Record Dates
Results First Posted: June 17, 2014
Last Update Posted: February 22, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Boehringer Ingelheim Policy on Transparency and Publication http://trials.boehringer-ingelheim.com/transparency_policy.html
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Empagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs