A Phase III, Multicentre, International, Randomised, Parallel Group, Double Blind Cardiovascular Safety Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) Compared to Usual Care in Type 2 Diabetes Mellitus Patients With Increased Cardiovascular Risk
A Phase III, Multicentre, International, Randomised, Parallel Group, Double Blind Cardiovascular Safety Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) Compared to Usual Care in Type 2 Diabetes Mellitus Patients With Increased Cardiovascular Risk
The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk.
Inclusion criteria:
Exclusion criteria:
Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day)
Indication of liver disease, defined by serum levels of either alanine aminotransferase (ALT), aspartate aminotransferase ALT or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at screening and/or run in.
Planned cardiac surgery or angioplasty within 3 months
Impaired renal function, defined as Glomerular Filtration Rate <30 ml/min (severe renal impairment, Modification of Diet in Renal Disease formula) during screening or run in.
Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia)
Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
Contraindications to background therapy according to the local label
Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight
Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except type 2 diabetes mellitus
Pre-menopausal women (last menstruation <+ 1 year prior to informed consent) who:
Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
Participation in another trial with an investigational drug within 30 days prior to informed consent
Any other clinical condition that would jeopardize patients safety while participating in this clinical trial
Acute coronary syndrome, stroke or TIA within 2 months prior to informed consent
Little Rock, Alaska, United States
Washington D.C., District of Columbia, United States
Feasterville-Trevose, Pennsylvania, United States
North Myrtle Beach, South Carolina, United States
South Chesterfield, Virginia, United States
Capital Federal, Argentina
Capital Federal, Argentina
Capital Federal, Argentina
Parque Velez Sarfield, Argentina
Massemen-Wetteren, Belgium
Vila Albuquerque, Brazil
Villa Clementino, Brazil
Bourg Des Cptes, France
Equeurdreville Haineville, France
Saint Priez En Jarez, France
Vijaywada, India
Chuo-ku, Tokyo, Japan
Gifushi, Gifu, Japan
Kamigyo-ku, Kyotoshi, Kyoto, Japan
Kishiwadashi. Osaka, Japan
Kita-ku, Nagoyashi, Aichi, Japan
Kumamoto-shi, Kumamoto, Japan
Mitoshi, Ibaraki, Japan
Nishi-ku, Sapporoshi, Hokkaido, Japan
Toyamashi, Toyama, Japan
Kedah, Malaysia
Kelantan, Malaysia
Selangor Darul Ehsan, Malaysia
San Lucas Tepetlcalco, Mexico
Grafton / Auckland, New Zealand
Jaro Iloilo City, Philippines
Baia Mare Maramures, Romania
Chatsworth Unit 10, South Africa
Daejoen, South Korea
Badía Del Vallès - Barcelona, Spain
Mahadahonda (Madrid), Spain
Muang District, Thailand
Nakhonratchasima, Thailand
Pathum Tani, Thailand