Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

This study will investigate the efficacy and long term safety and tolerability of BI 10773 in type 2 diabetic patients.

Key facts

Study ID

NCT01289990

Run by

Boehringer Ingelheim

People needed

2705

Starts

2011-02-01

Expected to finish

2013-05-01

Last updated by the study team

2014-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients completing the entire treatment period of the preceding double-blind trial 1245.19, 1245.20 or 1245.23 with or without rescue therapy.
• Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice and local legislation.

You may not qualify if…

• Patient who meet one or more of the withdrawal criteria of the treatment period of the previous trial 1245.19, 1245.20 or 1245.23.
• Indication of liver disease, defined by serum levels of either alanine aminotransferase , aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal as determined during last visit of preceding trial.
• Impaired renal function defined as glomerular filtration rate<30 ml/min (severe renal impairment, Modification of Diet in Renal Disease formula) as determined during last visit of preceding trial.
• Contraindications to sitagliptin, pioglitazone, metformin or sulfonylurea according to local label, which started during trial participation in 1245.19, 1245.20 or 1245.23
• Pre-menopausal women (last menstruation < or = 1 year prior to informed consent) who are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner.
• 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 (except 1245.19, 1245.20 and 1245.23).
• Any other clinical condition that would jeopardize patient's safety while participating in this clinical trial.

Where it is running

• 1245.31.10162 Boehringer Ingelheim Investigational Site — Glendale, Arizona, United States
• 1245.31.10124 Boehringer Ingelheim Investigational Site — Mesa, Arizona, United States
• 1245.31.10108 Boehringer Ingelheim Investigational Site — Phoenix, Arizona, United States
• 1245.31.10046 Boehringer Ingelheim Investigational Site — Tempe, Arizona, United States
• 1245.31.10154 Boehringer Ingelheim Investigational Site — Chino, California, United States
• 1245.31.10149 Boehringer Ingelheim Investigational Site — Rancho Cucamonga, California, United States
• 1245.31.10131 Boehringer Ingelheim Investigational Site — West Hills, California, United States
• 1245.31.10038 Boehringer Ingelheim Investigational Site — Northglenn, Colorado, United States
• 1245.31.10127 Boehringer Ingelheim Investigational Site — Waterbury, Connecticut, United States
• 1245.31.10137 Boehringer Ingelheim Investigational Site — Clearwater, Florida, United States
• 1245.31.10133 Boehringer Ingelheim Investigational Site — Jupiter, Florida, United States
• 1245.31.10006 Boehringer Ingelheim Investigational Site — Miami, Florida, United States
• 1245.31.10085 Boehringer Ingelheim Investigational Site — Plantation, Florida, United States
• 1245.31.10080 Boehringer Ingelheim Investigational Site — Decatur, Georgia, United States
• 1245.31.10077 Boehringer Ingelheim Investigational Site — Perry, Georgia, United States
• 1245.31.10001 Boehringer Ingelheim Investigational Site — Chicago, Illinois, United States
• 1245.31.10159 Boehringer Ingelheim Investigational Site — Des Moines, Iowa, United States
• 1245.31.10014 Boehringer Ingelheim Investigational Site — Dubuque, Iowa, United States
• 1245.31.10117 Boehringer Ingelheim Investigational Site — Arkansas City, Kansas, United States
• 1245.31.10157 Boehringer Ingelheim Investigational Site — Newton, Kansas, United States
• 1245.31.10146 Boehringer Ingelheim Investigational Site — Louisville, Kentucky, United States
• 1245.31.10003 Boehringer Ingelheim Investigational Site — Dearborn, Michigan, United States
• 1245.31.10059 Boehringer Ingelheim Investigational Site — New Hyde Park, New York, United States
• 1245.31.10034 Boehringer Ingelheim Investigational Site — Rochester, New York, United States
• 1245.31.10145 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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