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NCT01370005 Clinical Trial

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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01370005
Other study ID # 1245.48
Secondary ID 2011-000347-25
Status Completed
Phase Phase 3
First received June 8, 2011
Last updated January 22, 2016
Start date June 2011
Est. completion date July 2012

Study information
Verified date January 2016
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Canada: Health CanadaCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyEstonia: The State Agency of MedicineFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesLebanon:Netherlands:Norway: Norwegian Medicines AgencySweden: Medical Products AgencyUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 825
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
Placebo matching BI 10773 low dose
• BI 10773
BI 10773 high dose once daily
• Placebo
Placebo matching BI 10773 low dose
• BI 10773
BI 10773 low dose once daily
• Placebo
Placebo matching BI 10773 high dose
• Placebo
Placebo matching BI 10773 high dose

Locations
Country Name City State
Canada 1245.48.20004 Boehringer Ingelheim Investigational Site Brampton Ontario
Canada 1245.48.20006 Boehringer Ingelheim Investigational Site Etobicoke Ontario
Canada 1245.48.20001 Boehringer Ingelheim Investigational Site Halifax Nova Scotia
Canada 1245.48.20007 Boehringer Ingelheim Investigational Site Oakville Ontario
Canada 1245.48.20005 Boehringer Ingelheim Investigational Site Thornhill Ontario
Canada 1245.48.20003 Boehringer Ingelheim Investigational Site Toronto Ontario
Canada 1245.48.20002 Boehringer Ingelheim Investigational Site Winnipeg Manitoba
Czech Republic 1245.48.42003 Boehringer Ingelheim Investigational Site Benesov
Czech Republic 1245.48.42005 Boehringer Ingelheim Investigational Site Brno
Czech Republic 1245.48.42002 Boehringer Ingelheim Investigational Site Mlada Boleslav
Czech Republic 1245.48.42006 Boehringer Ingelheim Investigational Site Neratovice
Czech Republic 1245.48.42008 Boehringer Ingelheim Investigational Site Olomouc
Czech Republic 1245.48.42004 Boehringer Ingelheim Investigational Site Opocno
Czech Republic 1245.48.42007 Boehringer Ingelheim Investigational Site Pribram
Czech Republic 1245.48.42001 Boehringer Ingelheim Investigational Site Slany
Denmark 1245.48.45006 Boehringer Ingelheim Investigational Site Aalborg
Denmark 1245.48.45009 Boehringer Ingelheim Investigational Site Aarhus C
Denmark 1245.48.45008 Boehringer Ingelheim Investigational Site Hellerup
Denmark 1245.48.45002 Boehringer Ingelheim Investigational Site Helsingør
Denmark 1245.48.45010 Boehringer Ingelheim Investigational Site Hillerød
Denmark 1245.48.45003 Boehringer Ingelheim Investigational Site København NV
Denmark 1245.48.45001 Boehringer Ingelheim Investigational Site Rødovre
Denmark 1245.48.45004 Boehringer Ingelheim Investigational Site Rødovre
Denmark 1245.48.45005 Boehringer Ingelheim Investigational Site Vaerløse
Denmark 1245.48.45007 Boehringer Ingelheim Investigational Site Vojens
Estonia 1245.48.37203 Boehringer Ingelheim Investigational Site Pärnu
Estonia 1245.48.37201 Boehringer Ingelheim Investigational Site Tallinn
Estonia 1245.48.37202 Boehringer Ingelheim Investigational Site Tallinn
Estonia 1245.48.37204 Boehringer Ingelheim Investigational Site Tallinn
Finland 1245.48.35802 Boehringer Ingelheim Investigational Site Helsinki
Finland 1245.48.35805 Boehringer Ingelheim Investigational Site Joensuu
Finland 1245.48.35806 Boehringer Ingelheim Investigational Site Kouvola
Finland 1245.48.35803 Boehringer Ingelheim Investigational Site Oulu
Finland 1245.48.35804 Boehringer Ingelheim Investigational Site Pori
Finland 1245.48.35801 Boehringer Ingelheim Investigational Site Turku
Finland 1245.48.35807 Boehringer Ingelheim Investigational Site Turku
France 1245.48.33004 Boehringer Ingelheim Investigational Site Angers
France 1245.48.33008 Boehringer Ingelheim Investigational Site Bourges
France 1245.48.33005 Boehringer Ingelheim Investigational Site Mont de Marsan
France 1245.48.33001 Boehringer Ingelheim Investigational Site Nantes Cedex 1
France 1245.48.33006 Boehringer Ingelheim Investigational Site Orthez
France 1245.48.33003 Boehringer Ingelheim Investigational Site Tierce
France 1245.48.33007 Boehringer Ingelheim Investigational Site Tours
Germany 1245.48.49001 Boehringer Ingelheim Investigational Site Berlin
Germany 1245.48.49008 Boehringer Ingelheim Investigational Site Berlin
Germany 1245.48.49003 Boehringer Ingelheim Investigational Site Dresden
Germany 1245.48.49004 Boehringer Ingelheim Investigational Site Hannover
Germany 1245.48.49005 Boehringer Ingelheim Investigational Site Lüneburg
Germany 1245.48.49002 Boehringer Ingelheim Investigational Site Mainz
Germany 1245.48.49010 Boehringer Ingelheim Investigational Site Nürnberg
Germany 1245.48.49009 Boehringer Ingelheim Investigational Site Pirna
Germany 1245.48.49007 Boehringer Ingelheim Investigational Site Schkeuditz
Germany 1245.48.49006 Boehringer Ingelheim Investigational Site Teuchern
Lebanon 1245.48.96003 Boehringer Ingelheim Investigational Site Baabda
Lebanon 1245.48.96001 Boehringer Ingelheim Investigational Site Beirut
Lebanon 1245.48.96002 Boehringer Ingelheim Investigational Site Lebanon
Netherlands 1245.48.31011 Boehringer Ingelheim Investigational Site Breda
Netherlands 1245.48.31012 Boehringer Ingelheim Investigational Site Eindhoven
Netherlands 1245.48.31009 Boehringer Ingelheim Investigational Site Etten Leur
Netherlands 1245.48.31014 Boehringer Ingelheim Investigational Site Groningen
Netherlands 1245.48.31013 Boehringer Ingelheim Investigational Site Leiderdorp
Netherlands 1245.48.31003 Boehringer Ingelheim Investigational Site Oude Pekela
Netherlands 1245.48.31016 Boehringer Ingelheim Investigational Site Rotterdam
Netherlands 1245.48.31006 Boehringer Ingelheim Investigational Site Soerendonk
Netherlands 1245.48.31008 Boehringer Ingelheim Investigational Site Spijkenisse
Netherlands 1245.48.31002 Boehringer Ingelheim Investigational Site Swifterbant
Netherlands 1245.48.31015 Boehringer Ingelheim Investigational Site Velp
Netherlands 1245.48.31010 Boehringer Ingelheim Investigational Site Woerden
Netherlands 1245.48.31019 Boehringer Ingelheim Investigational Site Zijndrecht
Netherlands 1245.48.31017 Boehringer Ingelheim Investigational Site Zoetermeer
Norway 1245.48.47009 Boehringer Ingelheim Investigational Site Ålesund
Norway 1245.48.47008 Boehringer Ingelheim Investigational Site Elverum
Norway 1245.48.47007 Boehringer Ingelheim Investigational Site Hamar
Norway 1245.48.47002 Boehringer Ingelheim Investigational Site Kløfta
Norway 1245.48.47001 Boehringer Ingelheim Investigational Site Oslo
Norway 1245.48.47003 Boehringer Ingelheim Investigational Site Oslo
Norway 1245.48.47004 Boehringer Ingelheim Investigational Site Oslo
Norway 1245.48.47005 Boehringer Ingelheim Investigational Site Oslo
Norway 1245.48.47006 Boehringer Ingelheim Investigational Site Sørumsand
Sweden 1245.48.46002 Boehringer Ingelheim Investigational Site Härnösand
Sweden 1245.48.46004 Boehringer Ingelheim Investigational Site Järfälla
Sweden 1245.48.46003 Boehringer Ingelheim Investigational Site Lund
Sweden 1245.48.46007 Boehringer Ingelheim Investigational Site Malmö
Sweden 1245.48.46006 Boehringer Ingelheim Investigational Site Skene
Sweden 1245.48.46001 Boehringer Ingelheim Investigational Site Stockholm
United States 1245.48.10011 Boehringer Ingelheim Investigational Site Addison Illinois
United States 1245.48.10005 Boehringer Ingelheim Investigational Site Akron Ohio
United States 1245.48.10010 Boehringer Ingelheim Investigational Site Albuquerque New Mexico
United States 1245.48.10019 Boehringer Ingelheim Investigational Site Arlington Heights Illinois
United States 1245.48.10036 Boehringer Ingelheim Investigational Site Charlotte North Carolina
United States 1245.48.10022 Boehringer Ingelheim Investigational Site Chicago Illinois
United States 1245.48.10034 Boehringer Ingelheim Investigational Site Dallas Texas
United States 1245.48.10008 Boehringer Ingelheim Investigational Site Davie Florida
United States 1245.48.10025 Boehringer Ingelheim Investigational Site Edgewater Florida
United States 1245.48.10013 Boehringer Ingelheim Investigational Site Erie Pennsylvania
United States 1245.48.10007 Boehringer Ingelheim Investigational Site Houston Texas
United States 1245.48.10009 Boehringer Ingelheim Investigational Site Houston Texas
United States 1245.48.10042 Boehringer Ingelheim Investigational Site Houston Texas
United States 1245.48.10024 Boehringer Ingelheim Investigational Site Huntsville Alabama
United States 1245.48.10001 Boehringer Ingelheim Investigational Site Jacksonville Florida
United States 1245.48.10004 Boehringer Ingelheim Investigational Site Kettering Ohio
United States 1245.48.10029 Boehringer Ingelheim Investigational Site Knoxville Tennessee
United States 1245.48.10014 Boehringer Ingelheim Investigational Site Lincoln California
United States 1245.48.10030 Boehringer Ingelheim Investigational Site Long Beach California
United States 1245.48.10033 Boehringer Ingelheim Investigational Site Long Beach California
United States 1245.48.10027 Boehringer Ingelheim Investigational Site Los Angeles California
United States 1245.48.10012 Boehringer Ingelheim Investigational Site Marietta Georgia
United States 1245.48.10015 Boehringer Ingelheim Investigational Site Memphis Tennessee
United States 1245.48.10016 Boehringer Ingelheim Investigational Site Miami Florida
United States 1245.48.10003 Boehringer Ingelheim Investigational Site Orem Utah
United States 1245.48.10035 Boehringer Ingelheim Investigational Site Palm Harbor Florida
United States 1245.48.10018 Boehringer Ingelheim Investigational Site Pensacola Florida
United States 1245.48.10002 Boehringer Ingelheim Investigational Site Phoenix Arizona
United States 1245.48.10032 Boehringer Ingelheim Investigational Site Pinellas Park Florida
United States 1245.48.10020 Boehringer Ingelheim Investigational Site Pittsburgh Pennsylvania
United States 1245.48.10023 Boehringer Ingelheim Investigational Site Port Orchard Washington
United States 1245.48.10026 Boehringer Ingelheim Investigational Site San Antonio Texas
United States 1245.48.10041 Boehringer Ingelheim Investigational Site Tustin California
United States 1245.48.10039 Boehringer Ingelheim Investigational Site West Hills California
United States 1245.48.10017 Boehringer Ingelheim Investigational Site Wichita Kansas

Sponsors (2)
Lead Sponsor Collaborator
Boehringer Ingelheim Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Canada,  Czech Republic,  Denmark,  Estonia,  Finland,  France,  Germany,  Lebanon,  Netherlands,  Norway,  Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Other Confirmed Hypoglycaemic Adverse Events Number of participants with confirmed hypoglycaemic adverse events From drug administration until last drug administration plus seven days, up to 171 days No
Primary HbA1c Change From Baseline Change from baseline in HbA1c after 12 weeks of treatment. Baseline and 12 weeks No
Primary Mean 24-hour Systolic Blood Pressure Change From Baseline Change from baseline of mean 24-hour systolic blood pressure (SBP). Baseline and 12 weeks No
Secondary Mean 24-hour Diastolic Blood Pressure Change From Baseline Change from baseline in mean 24-hour diastolic blood pressure (DBP) after 12 weeks. Baseline and 12 weeks No
Secondary Proportion of Patients With HbA1c <7% Proportion of patients with HbA1c <7% after 12 weeks. Baseline and 12 weeks No
Secondary Fasting Plasma Glucose (FPG) Change From Baseline Change from baseline in FPG after 12 weeks of treatment. Baseline and 12 weeks No
Secondary Body Weight Change From Baseline Change from baseline in body weight after 12 weeks of treatment. Baseline and 12 weeks No
Secondary Daytime Mean Systolic Blood Pressure (SBP) Change From Baseline Change from baseline in daytime mean SBP after 12 weeks of treatment. Baseline and 12 weeks No
Secondary Daytime Mean Diastolic Blood Pressure (DBP) Change From Baseline Change from baseline in daytime mean DBP after 12 weeks of treatment. Baseline and 12 weeks No
Secondary Nighttime Mean Systolic Blood Pressure (SBP) Change From Baseline Change from baseline in nighttime mean SBP after 12 weeks of treatment. Baseline and 12 weeks No
Secondary Nighttime Mean Diastolic Blood Pressure (DBP) Change From Baseline Change from baseline in nighttime mean DBP after 12 weeks of treatment. Baseline and 12 weeks No
Secondary Trough Mean Seated Systolic Blood Pressure (SBP) Change From Baseline Change from baseline in Trough Mean Seated SBP after 12 weeks of treatment. Baseline and 12 weeks No
Secondary Trough Mean Seated Diastolic Blood Pressure (DBP) Change From Baseline Change from baseline in trough mean seated DBP after 12 weeks of treatment. Baseline and 12 weeks No
Secondary Proportion of Patients Reaching Blood Pressure <130/80 mmHg Proportion of patients reaching blood pressure <130/80 mmHg after 12 weeks of treatment Baseline and 12 weeks No
Secondary Composite Endpoint of Change From Baseline of HbA1c, Systolic Blood Pressure and Body Weight 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% Baseline and 12 weeks No
Secondary Orthostatic Blood Pressure Orthostatic blood pressure (BP) at baseline and after 12 weeks of treatment. Baseline and 12 weeks No
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