Efficacy and Safety of Empagliflozin (BI 10773) in Patients With Type 2 Diabetes and Renal Impairment

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2, Renal Insufficiency

In brief

This study will investigate the efficacy and safety of the BI 10773 in type 2 diabetic patients with renal impairment in order to provide these data for approval for BI 10773 as an antidiabetic agent by regulatory authorities.

Key facts

Study ID

NCT01164501

Run by

Boehringer Ingelheim

People needed

741

Starts

2010-07-01

Expected to finish

2012-07-01

Last updated by the study team

2014-06-16

Who can join

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

You may qualify if…

• Diagnosis of type 2 diabetes mellitus prior to informed consent and an estimated glomerular filtration rate of <90 ml/min.
• Male and female patients on diet and exercise regimen who are pre-treated with any antidiabetic therapy and are on the maximum tolerated dose which has been unchanged for 12 weeks prior to randomisation.
• HbA1c greater than or equal to 7.0% and less than or equal to 10.0% .
• Aged 18 years or above.
• Body Mass Index less than or equal to 45 kg/m2

You may not qualify if…

• Uncontrolled hyperglycaemia defined as >13.3 mmol/L after an overnight fast during placebo run-in.
• Impaired renal function, defined as an estimated glomerular filtration rate <15 ml/min.
• Renal impairment requiring any form of chronic dialysis.
• Requiring acute dialysis within three months prior to informed consent.
• Renal transplant recipient.
• Myocardial infarction, stroke or Transient Ischemic Attack within three months prior to informed consent.
• Indication of liver disease.
• Bariatric surgery within the past two years.
• Medical history of cancer.
• Blood dyscrasias or any disorders causing hemolysis or unstable red blood cell.
• Contraindications to pre-existing background antidiabetic therapy.
• Treatment with anti-obesity drugs.
• Current treatment with systemic steroids or change in dosage of thyroid hormones within six weeks prior to informed consent or any other uncontrolled endocrine disorder except Type 2 Diabetes.
• Pre-menopausal women who are nursing or pregnant or are of child-bearing potential and are not practising an acceptable method of birth control.

Where it is running

• 1245.36.10019 Boehringer Ingelheim Investigational Site — Lomita, California, United States
• 1245.36.10017 Boehringer Ingelheim Investigational Site — Plantation, Florida, United States
• 1245.36.10009 Boehringer Ingelheim Investigational Site — West Palm Beach, Florida, United States
• 1245.36.10018 Boehringer Ingelheim Investigational Site — Honolulu, Hawaii, United States
• 1245.36.10015 Boehringer Ingelheim Investigational Site — Shreveport, Louisiana, United States
• 1245.36.10021 Boehringer Ingelheim Investigational Site — Endwell, New York, United States
• 1245.36.10008 Boehringer Ingelheim Investigational Site — Greenville, North Carolina, United States
• 1245.36.10005 Boehringer Ingelheim Investigational Site — Bethlehem, Pennsylvania, United States
• 1245.36.10003 Boehringer Ingelheim Investigational Site — Melrose Park, Pennsylvania, United States
• 1245.36.10004 Boehringer Ingelheim Investigational Site — Greer, South Carolina, United States
• 1245.36.10012 Boehringer Ingelheim Investigational Site — Corpus Christi, Texas, United States
• 1245.36.10013 Boehringer Ingelheim Investigational Site — Dallas, Texas, United States
• 1245.36.10002 Boehringer Ingelheim Investigational Site — Houston, Texas, United States
• 1245.36.10007 Boehringer Ingelheim Investigational Site — San Antonio, Texas, United States
• 1245.36.10023 Boehringer Ingelheim Investigational Site — Renton, Washington, United States
• 1245.36.10011 Boehringer Ingelheim Investigational Site — Spokane, Washington, United States
• 1245.36.10006 Boehringer Ingelheim Investigational Site — Tacoma, Washington, United States
• 1245.36.20052 Boehringer Ingelheim Investigational Site — Calgary, Alberta, Canada
• 1245.36.20054 Boehringer Ingelheim Investigational Site — Calgary, Alberta, Canada
• 1245.36.20023 Boehringer Ingelheim Investigational Site — Edmonton, Alberta, Canada
• 1245.36.20055 Boehringer Ingelheim Investigational Site — Edmonton, Alberta, Canada
• 1245.36.20048 Boehringer Ingelheim Investigational Site — Winnipeg, Manitoba, Canada
• 1245.36.20051 Boehringer Ingelheim Investigational Site — Mississauga, Ontario, Canada
• 1245.36.20086 Boehringer Ingelheim Investigational Site — Thornhill, Ontario, Canada
• 1245.36.10014 Boehringer Ingelheim Investigational Site — Anaheim, California, United States

Full record on ClinicalTrials.gov

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