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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

Tracking Information
First Submitted Date  ICMJE June 8, 2011
First Posted Date  ICMJE June 9, 2011
Results First Submitted Date  ICMJE May 16, 2014
Results First Posted Date  ICMJE June 17, 2014
Last Update Posted Date February 22, 2016
Study Start Date  ICMJE June 2011
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2014)
  • HbA1c Change From Baseline [ Time Frame: Baseline and 12 weeks ]
    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 ]
    Change from baseline of mean 24-hour systolic blood pressure (SBP).
Original Primary Outcome Measures  ICMJE
 (submitted: June 8, 2011)
  • change of HbA1c from baseline [ Time Frame: 12 weeks ]
  • change of mean 24-hour systolic blood pressure from baseline [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2014)
  • 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.
  • Proportion of Patients With HbA1c <7% [ Time Frame: Baseline and 12 weeks ]
    Proportion of patients with HbA1c <7% after 12 weeks.
  • Fasting Plasma Glucose (FPG) Change From Baseline [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in FPG after 12 weeks of treatment.
  • Body Weight Change From Baseline [ Time Frame: Baseline and 12 weeks ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Orthostatic blood pressure (BP) at baseline and after 12 weeks of treatment.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2011)
  • change of mean 24-hour diastolic blood pressure from baseline [ Time Frame: 12 weeks ]
  • Proportion of Patients With HbA1c <7% [ Time Frame: 12 week ]
  • change of fasting plasma glucose from baseline [ Time Frame: 12 week ]
  • change of body weight from baseline [ Time Frame: 12 week ]
  • change of daytime systolic blood pressure from baseline [ Time Frame: 12 week ]
  • change of daytime diastolic blood pressure from baseline [ Time Frame: 12 week ]
  • change of nighttime systolic blood pressure from baseline [ Time Frame: 12 week ]
  • change of nighttime diastolic blood pressure from baseline [ Time Frame: 12 week ]
  • change of trough mean sitting systolic blood pressure from baseline [ Time Frame: 12 week ]
  • change of trough mean sitting diastolic blood pressure from baseline [ Time Frame: 12 week ]
  • change of orthostatic blood pressure [ Time Frame: 12 week ]
  • Proportion of Patients Reaching Blood Pressure <130/80 mmHg [ Time Frame: 12 week ]
  • 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 ]
Current Other Pre-specified Outcome Measures
 (submitted: May 16, 2014)
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
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 12 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Patients With Type 2 Diabetes Mellitus
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus, Type 2
  • Hypertension
Intervention  ICMJE
  • Drug: Placebo
    Placebo matching BI 10773 low dose
  • Drug: BI 10773
    BI 10773 high dose once daily
  • Drug: BI 10773
    BI 10773 low dose once daily
  • Drug: Placebo
    Placebo matching BI 10773 high dose
Study Arms  ICMJE
  • Experimental: BI 10773 low dose
    BI 10773 low dose once daily
    Interventions:
    • Drug: Placebo
    • Drug: BI 10773
  • Experimental: BI 10773 high dose
    BI 10773 high dose once daily
    Interventions:
    • Drug: BI 10773
    • Drug: Placebo
  • Placebo Comparator: Placebo
    Placebo tablets matching BI 10773
    Interventions:
    • Drug: Placebo
    • Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 27, 2012)
825
Original Estimated Enrollment  ICMJE
 (submitted: June 8, 2011)
816
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Czech Republic,   Denmark,   Estonia,   Finland,   France,   Germany,   Lebanon,   Netherlands,   Norway,   Sweden,   United States
Removed Location Countries India
 
Administrative Information
NCT Number  ICMJE NCT01370005
Other Study ID Numbers  ICMJE 1245.48
2011-000347-25 ( EudraCT Number: EudraCT )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Boehringer Ingelheim Policy on Transparency and Publication http://trials.boehringer-ingelheim.com/transparency_policy.html
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP