Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes
Launched by BOEHRINGER INGELHEIM · Jul 21, 2010
Trial Information
Current as of April 25, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion criteria:
- • Diagnosis typ 2 diabetes mellitus
- • Male and female on diet and exercise regimen, pre-treated with metformin 12 weeks prior to randomisation
- • HbA1c equal or greater than 7.0% and less than or equal to 10% at visit 1
- • 18 years or more
- • BMI equal or less than 45Kg/m2
- Exclusion criteria:
- • Uncontrolled hyperglycemia defined as glucose more that 13.3 mmol/L after overnight fast during placebo run-in
- • Any other antidiabetic drug within 12 weeks prior to randomisation except metformin
- • Acute coronary syndrome (non-STEMI, STEMI unstable angina pectoris), stroke or transient ischemic attack within 12 weeks of informed consent
- • Indication of liver disease
- • Moderate to severe renal impairment
- • Bariatric surgery within past 2 years
- • Medical history of cancer or treatment for cancer within last 5 years
- • Blood dyscrasias or any disorders causing haemolysis or unstable red blood cell
- • Contraindications hypersensitivity to concomitant drugs
- • Treatment with anti-obesity drugs
Trial Officials
Boehringer Ingelheim
Study Chair
Boehringer Ingelheim
About Boehringer Ingelheim
Boehringer Ingelheim is a global, research-driven pharmaceutical company dedicated to improving health and quality of life through innovative therapies. Established in 1885 and headquartered in Ingelheim, Germany, the company focuses on the development of prescription medicines in key therapeutic areas, including respiratory diseases, cardiovascular health, oncology, and immunology. Boehringer Ingelheim is committed to advancing medical science through rigorous clinical trials and collaborative research, striving to bring novel treatments to patients while upholding the highest standards of safety and efficacy. With a strong emphasis on sustainability and corporate responsibility, the company aims to make a meaningful impact on global health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Hot Springs, Arkansas, United States
Sacramento, California, United States
West Hills, California, United States
Bradednton, Florida, United States
Tampa, Florida, United States
Blue Ridge, Georgia, United States
Boise, Idaho, United States
Omaha, Nebraska, United States
Henderson, Nevada, United States
Rochester, New York, United States
Shelby, North Carolina, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Perrysburg, Ohio, United States
Medford, Oregon, United States
Portland, Oregon, United States
Dallas, Texas, United States
Longview, Texas, United States
San Antonio, Texas, United States
Draper, Utah, United States
Salt Lake City, Utah, United States
Kenosha, Wisconsin, United States
Buenos Aires, , Argentina
Capital Federal, , Argentina
Córdoba, , Argentina
Córdoba, , Argentina
Graz, , Austria
Salzburg, , Austria
Wien, , Austria
Wien, , Austria
Wien, , Austria
Wien, , Austria
Calgary, Alberta, Canada
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Langley, British Columbia, Canada
Grand Falls Windsor, Newfoundland And Labrador, Canada
Mount Pearl, Newfoundland And Labrador, Canada
St. John's, Newfoundland And Labrador, Canada
Halifax, Nova Scotia, Canada
Collingwood, Ontario, Canada
Stayner, Ontario, Canada
Strathroy, Ontario, Canada
Sudbury, Ontario, Canada
Chicoutimi, Quebec, Canada
Chicoutimi, Quebec, Canada
Gatineau, Quebec, Canada
Longueuil, Quebec, Canada
Montreal, Quebec, Canada
Sherbrooke, Quebec, Canada
Trois Rivieres, Quebec, Canada
Quebec, , Canada
Barranquilla, , Colombia
Bogota, , Colombia
Bogotá, , Colombia
Floridablanca, , Colombia
Brno, , Czech Republic
Holice, , Czech Republic
Mlada Boleslav, , Czech Republic
Praha 1, , Czech Republic
Slany, , Czech Republic
Slany, , Czech Republic
Uherske Hradiste, , Czech Republic
Zlin, , Czech Republic
Helsinki, , Finland
Joensuu, , Finland
Oulu, , Finland
Pori, , Finland
Hong Kong, , Hong Kong
Hong Kong, , Hong Kong
Kowloon, , Hong Kong
Ahmedabad, , India
Bangalore, , India
Bangalore, , India
Bangalore, , India
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Chennai, , India
Chennai, , India
Hyderabad, , India
Kolkata, , India
Mangalore, , India
New Delhi, , India
Pune, , India
Uttar Pradesh, , India
Cagliari, , Italy
Chieri (To), , Italy
Lucca, , Italy
Milano, , Italy
Milano, , Italy
Monserrato (Ca), , Italy
Rimini, , Italy
Salerno, , Italy
Johor Bahru, , Malaysia
Kelantan, , Malaysia
Kuala Lumpur, , Malaysia
Kuala Lumpur, , Malaysia
Pahang, , Malaysia
Perak, , Malaysia
Pulau Pinang, , Malaysia
Selangor Darul Ehsan, , Malaysia
Aguascalientes, , Mexico
Cuautla, , Mexico
Guadalajara, , Mexico
Mexico, , Mexico
'S Hertogenbosch, , Netherlands
Losser, , Netherlands
Rotterdam, , Netherlands
Hønefoss, , Norway
Oslo, , Norway
Sandefjord, , Norway
Cavite City, , Philippines
Cebu City, , Philippines
Jaro Iloilo City, , Philippines
Manila, , Philippines
Manila, , Philippines
Pasig City, , Philippines
Quezon City, , Philippines
Tacloban, , Philippines
Tagbilaran City, Bohol, , Philippines
Amadora, , Portugal
Lisboa, , Portugal
Porto, , Portugal
Vila Nova De Gaia, , Portugal
Boksburg North, , South Africa
Bryanston, , South Africa
Cape Town, , South Africa
Cape Town, , South Africa
Durban, , South Africa
Durban, , South Africa
Krugersdorp, , South Africa
Lenasia South, , South Africa
Lenasia, , South Africa
Pretoria, , South Africa
Barcelona, , Spain
Barcelona, , Spain
Burjasot, , Spain
Centelles, , Spain
Granada, , Spain
Madrid, , Spain
Madrid, , Spain
Mataró, , Spain
Pineda De Mar, , Spain
San Sebastian De Los Reyes, , Spain
Tarrega Lleida, , Spain
Borås, , Sweden
Lund, , Sweden
Malmö, , Sweden
Stockholm, , Sweden
Stockholm, , Sweden
Stockholm, , Sweden
Uppsala, , Sweden
örebro, , Sweden
Ascona, , Switzerland
Bern, , Switzerland
Changhua, , Taiwan
Taichung, , Taiwan
Tainan Hsien, , Taiwan
Taipei Hsien, , Taiwan
Taipei, , Taiwan
Bangkok, , Thailand
Bangkok, , Thailand
Muang District, , Thailand
Nakhonratchasima, , Thailand
Addlestone, , United Kingdom
Ashford, , United Kingdom
Balham, , United Kingdom
Barnstable, , United Kingdom
Blackpool, , United Kingdom
Bradford On Avon, , United Kingdom
Burbage, , United Kingdom
Chestfield, Whitstable, , United Kingdom
Chippenham, , United Kingdom
Chippenham, , United Kingdom
Coventry, , United Kingdom
Doncaster, , United Kingdom
Ely, , United Kingdom
Midsomer Norton, , United Kingdom
Nantwich, , United Kingdom
Whitstable, , United Kingdom
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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