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

Condition(s) targeted: Diabetes Mellitus, Type 2; Hypertension

Intervention: BI 10773 (Drug); BI 10773 (Drug); Placebo (Drug); Placebo (Drug); Placebo (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Boehringer Ingelheim Pharmaceuticals

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim Pharmaceuticals

Overall contact:
Boehringer Ingelheim Call Center, Phone: 1-800-243-0127, Email: clintriage.rdg@boehringer-ingelheim.com

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

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

Primary outcome:

change of HbA1c from baseline

change of mean 24-hour systolic blood pressure from baseline

Secondary outcome:

change of mean 24-hour diastolic blood pressure from baseline

Proportion of patients with HbA1c <7%

change of fasting plasma glucose from baseline

change of body weight from baseline

change of daytime systolic blood pressure from baseline

change of daytime diastolic blood pressure from baseline

change of nighttime systolic blood pressure from baseline

change of nighttime diastolic blood pressure from baseline

change of trough mean sitting systolic blood pressure from baseline

change of trough mean sitting diastolic blood pressure from baseline

change of orthostatic blood pressure

proportion of patients reaching blood pressure <130/80 mmHg

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%

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Boehringer Ingelheim Call Center, Phone: 1-800-243-0127, Email: clintriage.rdg@boehringer-ingelheim.com

1245.48.42003 Boehringer Ingelheim Investigational Site, Benesov, Czech Republic; Recruiting

1245.48.42005 Boehringer Ingelheim Investigational Site, Brno, Czech Republic; Recruiting

1245.48.42002 Boehringer Ingelheim Investigational Site, Mlada Boleslav, Czech Republic; Recruiting

1245.48.42006 Boehringer Ingelheim Investigational Site, Neratovice, Czech Republic; Recruiting

1245.48.42008 Boehringer Ingelheim Investigational Site, Olomouc, Czech Republic; Recruiting

1245.48.42004 Boehringer Ingelheim Investigational Site, Opocno, Czech Republic; Recruiting

1245.48.42007 Boehringer Ingelheim Investigational Site, Pribram, Czech Republic; Recruiting

1245.48.42001 Boehringer Ingelheim Investigational Site, Slany, Czech Republic; Recruiting

1245.48.45006 Boehringer Ingelheim Investigational Site, Aalborg, Denmark; Recruiting

1245.48.45009 Boehringer Ingelheim Investigational Site, Aarhus C, Denmark; Recruiting

1245.48.45008 Boehringer Ingelheim Investigational Site, Hellerup, Denmark; Recruiting

1245.48.45002 Boehringer Ingelheim Investigational Site, Helsingør, Denmark; Recruiting

1245.48.45010 Boehringer Ingelheim Investigational Site, Hillerød, Denmark; Recruiting

1245.48.45003 Boehringer Ingelheim Investigational Site, København NV, Denmark; Recruiting

1245.48.45001 Boehringer Ingelheim Investigational Site, Rødovre, Denmark; Recruiting

1245.48.45004 Boehringer Ingelheim Investigational Site, Rødovre, Denmark; Recruiting

1245.48.45005 Boehringer Ingelheim Investigational Site, Vaerløse, Denmark; Recruiting

1245.48.45007 Boehringer Ingelheim Investigational Site, Vojens, Denmark; Recruiting

1245.48.37203 Boehringer Ingelheim Investigational Site, Pärnu, Estonia; Recruiting

1245.48.37204 Boehringer Ingelheim Investigational Site, Tallinn, Estonia; Recruiting

1245.48.37202 Boehringer Ingelheim Investigational Site, Tallinn, Estonia; Recruiting

1245.48.37201 Boehringer Ingelheim Investigational Site, Tallinn, Estonia; Recruiting

1245.48.35802 Boehringer Ingelheim Investigational Site, Helsinki, Finland; Recruiting

1245.48.35805 Boehringer Ingelheim Investigational Site, Joensuu, Finland; Recruiting

1245.48.35806 Boehringer Ingelheim Investigational Site, Kouvola, Finland; Recruiting

1245.48.35803 Boehringer Ingelheim Investigational Site, Oulu, Finland; Recruiting

1245.48.35804 Boehringer Ingelheim Investigational Site, Pori, Finland; Recruiting

1245.48.35801 Boehringer Ingelheim Investigational Site, Turku, Finland; Recruiting

1245.48.35807 Boehringer Ingelheim Investigational Site, Turku, Finland; Recruiting

1245.48.33004 Boehringer Ingelheim Investigational Site, Angers, France; Recruiting

1245.48.33008 Boehringer Ingelheim Investigational Site, Bourges, France; Recruiting

1245.48.33002 Boehringer Ingelheim Investigational Site, Jarny, France; Recruiting

1245.48.33005 Boehringer Ingelheim Investigational Site, Mont de Marsan, France; Recruiting

1245.48.33001 Boehringer Ingelheim Investigational Site, Nantes Cedex 1, France; Recruiting

1245.48.33006 Boehringer Ingelheim Investigational Site, Orthez, France; Recruiting

1245.48.33003 Boehringer Ingelheim Investigational Site, Tierce, France; Recruiting

1245.48.33007 Boehringer Ingelheim Investigational Site, Tours, France; Recruiting

1245.48.49001 Boehringer Ingelheim Investigational Site, Berlin, Germany; Recruiting

1245.48.49008 Boehringer Ingelheim Investigational Site, Berlin, Germany; Recruiting

1245.48.49003 Boehringer Ingelheim Investigational Site, Dresden, Germany; Recruiting

1245.48.49004 Boehringer Ingelheim Investigational Site, Hannover, Germany; Recruiting

1245.48.49005 Boehringer Ingelheim Investigational Site, Lüneburg, Germany; Active, not recruiting

1245.48.49002 Boehringer Ingelheim Investigational Site, Mainz, Germany; Recruiting

1245.48.49010 Boehringer Ingelheim Investigational Site, Nürnberg, Germany; Recruiting

1245.48.49009 Boehringer Ingelheim Investigational Site, Pirna, Germany; Recruiting

1245.48.49007 Boehringer Ingelheim Investigational Site, Schkeuditz, Germany; Recruiting

1245.48.49006 Boehringer Ingelheim Investigational Site, Teuchern, Germany; Recruiting

1245.48.91001 Boehringer Ingelheim Investigational Site, Bangalore, India; Not yet recruiting

1245.48.91002 Boehringer Ingelheim Investigational Site, Bangalore, India; Not yet recruiting

1245.48.91004 Boehringer Ingelheim Investigational Site, Bangalore, India; Not yet recruiting

1245.48.91005 Boehringer Ingelheim Investigational Site, Belgaum, India; Not yet recruiting

1245.48.91011 Boehringer Ingelheim Investigational Site, Coimbatore, India; Not yet recruiting

1245.48.91003 Boehringer Ingelheim Investigational Site, Hyderabad, India; Not yet recruiting

1245.48.91008 Boehringer Ingelheim Investigational Site, Jaipur, India; Not yet recruiting

1245.48.91007 Boehringer Ingelheim Investigational Site, Mangalore, India; Not yet recruiting

1245.48.91009 Boehringer Ingelheim Investigational Site, Nagpur, India; Not yet recruiting

1245.48.91010 Boehringer Ingelheim Investigational Site, Nagpur, India; Not yet recruiting

1245.48.91006 Boehringer Ingelheim Investigational Site, Pune, India; Not yet recruiting

1245.48.96001 Boehringer Ingelheim Investigational Site, Beirut, Lebanon; Recruiting

1245.48.96002 Boehringer Ingelheim Investigational Site, Lebanon, Lebanon; Recruiting

1245.48.31011 Boehringer Ingelheim Investigational Site, Breda, Netherlands; Recruiting

1245.48.31012 Boehringer Ingelheim Investigational Site, Eindhoven, Netherlands; Recruiting

1245.48.31009 Boehringer Ingelheim Investigational Site, Etten Leur, Netherlands; Recruiting

1245.48.31014 Boehringer Ingelheim Investigational Site, Groningen, Netherlands; Recruiting

1245.48.31013 Boehringer Ingelheim Investigational Site, Leiderdorp, Netherlands; Recruiting

1245.48.31004 Boehringer Ingelheim Investigational Site, Lieshout, Netherlands; Recruiting

1245.48.31003 Boehringer Ingelheim Investigational Site, Oude Pekela, Netherlands; Recruiting

1245.48.31016 Boehringer Ingelheim Investigational Site, Rotterdam, Netherlands; Recruiting

1245.48.31006 Boehringer Ingelheim Investigational Site, Soerendonk, Netherlands; Recruiting

1245.48.31008 Boehringer Ingelheim Investigational Site, Spijkenisse, Netherlands; Recruiting

1245.48.31002 Boehringer Ingelheim Investigational Site, Swifterbant, Netherlands; Recruiting

1245.48.31015 Boehringer Ingelheim Investigational Site, Velp, Netherlands; Recruiting

1245.48.31010 Boehringer Ingelheim Investigational Site, Woerden, Netherlands; Recruiting

1245.48.31019 Boehringer Ingelheim Investigational Site, Zijndrecht, Netherlands; Recruiting

1245.48.31017 Boehringer Ingelheim Investigational Site, Zoetermeer, Netherlands; Recruiting

1245.48.47008 Boehringer Ingelheim Investigational Site, Elverum, Norway; Recruiting

1245.48.47007 Boehringer Ingelheim Investigational Site, Hamar, Norway; Recruiting

1245.48.47002 Boehringer Ingelheim Investigational Site, Kløfta, Norway; Recruiting

1245.48.47005 Boehringer Ingelheim Investigational Site, Oslo, Norway; Recruiting

1245.48.47001 Boehringer Ingelheim Investigational Site, Oslo, Norway; Recruiting

1245.48.47003 Boehringer Ingelheim Investigational Site, Oslo, Norway; Recruiting

1245.48.47004 Boehringer Ingelheim Investigational Site, Oslo, Norway; Recruiting

1245.48.47006 Boehringer Ingelheim Investigational Site, Sørumsand, Norway; Recruiting

1245.48.46002 Boehringer Ingelheim Investigational Site, Härnösand, Sweden; Recruiting

1245.48.46004 Boehringer Ingelheim Investigational Site, Järfälla, Sweden; Recruiting

1245.48.46003 Boehringer Ingelheim Investigational Site, Lund, Sweden; Recruiting

1245.48.46007 Boehringer Ingelheim Investigational Site, Malmö, Sweden; Recruiting

1245.48.46006 Boehringer Ingelheim Investigational Site, Skene, Sweden; Recruiting

1245.48.46001 Boehringer Ingelheim Investigational Site, Stockholm, Sweden; Recruiting

1245.48.10024 Boehringer Ingelheim Investigational Site, Huntsville, Alabama, United States; Not yet recruiting

1245.48.10002 Boehringer Ingelheim Investigational Site, Phoenix, Arizona, United States; Recruiting

1245.48.10040 Boehringer Ingelheim Investigational Site, Laguna Hills, California, United States; Not yet recruiting

1245.48.10033 Boehringer Ingelheim Investigational Site, Long Beach, California, United States; Not yet recruiting

1245.48.10030 Boehringer Ingelheim Investigational Site, Long Beach, California, United States; Not yet recruiting

1245.48.10027 Boehringer Ingelheim Investigational Site, Los Angeles, California, United States; Not yet recruiting

1245.48.10028 Boehringer Ingelheim Investigational Site, Norco, California, United States; Not yet recruiting

1245.48.10014 Boehringer Ingelheim Investigational Site, Roseville, California, United States; Recruiting

1245.48.10041 Boehringer Ingelheim Investigational Site, Tustin, California, United States; Not yet recruiting

1245.48.10039 Boehringer Ingelheim Investigational Site, West Hills, California, United States; Not yet recruiting

1245.48.10008 Boehringer Ingelheim Investigational Site, Davie, Florida, United States; Recruiting

1245.48.10038 Boehringer Ingelheim Investigational Site, Daytona Beach, Florida, United States; Not yet recruiting

1245.48.10025 Boehringer Ingelheim Investigational Site, Edgewater, Florida, United States; Not yet recruiting

1245.48.10001 Boehringer Ingelheim Investigational Site, Jacksonville, Florida, United States; Recruiting

1245.48.10016 Boehringer Ingelheim Investigational Site, Miami, Florida, United States; Not yet recruiting

1245.48.10035 Boehringer Ingelheim Investigational Site, Palm Harbor, Florida, United States; Not yet recruiting

1245.48.10018 Boehringer Ingelheim Investigational Site, Pensacola, Florida, United States; Not yet recruiting

1245.48.10032 Boehringer Ingelheim Investigational Site, Pinellas Park, Florida, United States; Not yet recruiting

1245.48.10012 Boehringer Ingelheim Investigational Site, Marietta, Georgia, United States; Recruiting

1245.48.10011 Boehringer Ingelheim Investigational Site, Addison, Illinois, United States; Not yet recruiting

1245.48.10019 Boehringer Ingelheim Investigational Site, Arlington Heights, Illinois, United States; Not yet recruiting

1245.48.10022 Boehringer Ingelheim Investigational Site, Chicago, Illinois, United States; Not yet recruiting

1245.48.10017 Boehringer Ingelheim Investigational Site, Wichita, Kansas, United States; Recruiting

1245.48.20002 Boehringer Ingelheim Investigational Site, Winnipeg, Manitoba, Canada; Recruiting

1245.48.10037 Boehringer Ingelheim Investigational Site, Kalamazoo, Michigan, United States; Not yet recruiting

1245.48.10010 Boehringer Ingelheim Investigational Site, Albuquerque, New Mexico, United States; Not yet recruiting

1245.48.10036 Boehringer Ingelheim Investigational Site, Charlotte, North Carolina, United States; Not yet recruiting

1245.48.20001 Boehringer Ingelheim Investigational Site, Halifax, Nova Scotia, Canada; Recruiting

1245.48.10005 Boehringer Ingelheim Investigational Site, Akron, Ohio, United States; Not yet recruiting

1245.48.10004 Boehringer Ingelheim Investigational Site, Kettering, Ohio, United States; Recruiting

1245.48.20004 Boehringer Ingelheim Investigational Site, Brampton, Ontario, Canada; Recruiting

1245.48.20006 Boehringer Ingelheim Investigational Site, Etobicoke, Ontario, Canada; Recruiting

1245.48.20007 Boehringer Ingelheim Investigational Site, Oakville, Ontario, Canada; Recruiting

1245.48.20005 Boehringer Ingelheim Investigational Site, Thornhill, Ontario, Canada; Recruiting

1245.48.20003 Boehringer Ingelheim Investigational Site, Toronto, Ontario, Canada; Recruiting

1245.48.10013 Boehringer Ingelheim Investigational Site, Erie, Pennsylvania, United States; Recruiting

1245.48.10020 Boehringer Ingelheim Investigational Site, Pittsburgh, Pennsylvania, United States; Recruiting

1245.48.10029 Boehringer Ingelheim Investigational Site, Knoxville, Tennessee, United States; Not yet recruiting

1245.48.10015 Boehringer Ingelheim Investigational Site, Memphis, Tennessee, United States; Not yet recruiting

1245.48.10034 Boehringer Ingelheim Investigational Site, Dallas, Texas, United States; Not yet recruiting

1245.48.10042 Boehringer Ingelheim Investigational Site, Houston, Texas, United States; Not yet recruiting

1245.48.10007 Boehringer Ingelheim Investigational Site, Houston, Texas, United States; Recruiting

1245.48.10009 Boehringer Ingelheim Investigational Site, Houston, Texas, United States; Recruiting

1245.48.10026 Boehringer Ingelheim Investigational Site, San Antonio, Texas, United States; Not yet recruiting

1245.48.10003 Boehringer Ingelheim Investigational Site, Orem, Utah, United States; Recruiting

1245.48.10023 Boehringer Ingelheim Investigational Site, Port Orchard, Washington, United States; Not yet recruiting

Starting date: June 2011
Last updated: November 17, 2011