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

Inclusion criteria:

1. Diagnosis of type 2 diabetes mellitus prior to informed consent and an estimatedglomerular filtration rate of <90 ml/min.

2. Male and female patients on diet and exercise regimen who are pre-treated with anyantidiabetic therapy and are on the maximum tolerated dose which has been unchangedfor 12 weeks prior to randomisation.

3. HbA1c greater than or equal to 7.0% and less than or equal to 10.0% .

4. Aged 18 years or above.

5. Body Mass Index less than or equal to 45 kg/m2

Exclusion criteria:

1. Uncontrolled hyperglycaemia defined as >13.3 mmol/L after an overnight fast duringplacebo run-in.

2. Impaired renal function, defined as an estimated glomerular filtration rate <15ml/min.

3. Renal impairment requiring any form of chronic dialysis.

4. Requiring acute dialysis within three months prior to informed consent.

5. Renal transplant recipient.

6. Myocardial infarction, stroke or Transient Ischemic Attack within three months priorto informed consent.

7. Indication of liver disease.

8. Bariatric surgery within the past two years.

9. Medical history of cancer.

10. Blood dyscrasias or any disorders causing hemolysis or unstable red blood cell.

11. Contraindications to pre-existing background antidiabetic therapy.

12. Treatment with anti-obesity drugs.

13. Current treatment with systemic steroids or change in dosage of thyroid hormoneswithin six weeks prior to informed consent or any other uncontrolled endocrinedisorder except Type 2 Diabetes.

14. Pre-menopausal women who are nursing or pregnant or are of child-bearing potential andare not practising an acceptable method of birth control.