BI 1245.36 TRIAL
Efficacy and Safety of BI 10883 in patients with Type 3 Diabetes and Renal Impairment.
Study Phase III
Purpose
The 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 of BI 10773 as an antidiabetic agent by regulatory authorities.
The study population will include those who meet the following inclusion/exclusion criteria, some of which are:
Inclusion criteria
- Men and women > 18 years of age.
- Signed & dated, written informed consent to participate in this study.
- Diagnosis of type 2 diabetes prior to informed consent and an estimated glomerular filtration rate of <90 ml/min.
- HbA1c > 7.0% and < 10.0%.
- BMI < 45 kg/m2.
- Must be on a diet and exercise regimen and are pre-treated with antidiabetic therapy and are on the maximum tolerated dose which has been unchanged for 12 weeks prior to randomization.
Exclusion criteria
- Uncontrolled hyperglycaemia defined as >13.3 mmol/L after an overnight fasting during placebo run-in.
- Impaired renal function, defined as an estimated glomerular filtration rate of <15 ml/min.
- Renal impairment requiring and form of chronic dialysis.
- Requiring acute dialysis within 3 months prior to informed consent.
- Renal transplant recipient.
- MI, Stoke, TIA within 3 months prior to informed consent.
- Indication of liver disease.
- Bariatric surgery within the past 2 years.
- Medical history of Cancer.
- Blood dycrasias or any disorders causing hemolysis or unstable red blood cell.
- Contraindication to pre-existing background antidiabetic therapy.
- Treatment with anti-obesity drugs.
To inquire if you are eligible for this study or to hear more about it, please contact:
Lori Brazee
Clinical Research Coordinator
Office#: 781-505-8710
Email: lbrazee@pchi.partners.org
