Status:
COMPLETED
Efficacy and Safety of Empagliflozin (BI 10773) in Patients With Type 2 Diabetes and Renal Impairment
Lead Sponsor:
Boehringer Ingelheim
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 2
Renal Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
741 Patients enrolled
Trial Details
Trial ID
NCT01164501
Start Date
July 1 2010
End Date
July 1 2012
Last Update
June 16 2014
Active Locations (127)
Enter a location and click search to find clinical trials sorted by distance.
1
1245.36.10014 Boehringer Ingelheim Investigational Site
Anaheim, California, United States
2
1245.36.10019 Boehringer Ingelheim Investigational Site
Lomita, California, United States
3
1245.36.10017 Boehringer Ingelheim Investigational Site
Plantation, Florida, United States
4
1245.36.10009 Boehringer Ingelheim Investigational Site
West Palm Beach, Florida, United States