Phase 3
N=741
Efficacy and Safety of Empagliflozin (BI 10773) in Patients With Type 2 Diabetes and Renal Impairment
Diabetes Mellitus, Type 2 · Renal Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT01164501 ↗Enrolled (actual)
741
Serious AEs
12.2%
Results posted
Jun 2014
Primary outcome: Primary: HbA1c Change From Baseline in Patients With Mild or Moderate Renal Impairment — 0.05; -0.46 percentage of HbA1c — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- BI 10773 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c Change From Baseline in Patients With Mild or Moderate Renal Impairment |
0.05; -0.46 | <0.0001 sig |
| PRIMARY HbA1c Change From Baseline in Patients With Mild Renal Impairment |
0.06; -0.46; -0.63 | <0.0001 sig |
| PRIMARY HbA1c Change From Baseline in Patients With Moderate Renal Impairment |
0.05; -0.37 | <0.0001 sig |
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 by regulatory authorities.
Eligibility Criteria
Inclusion criteria
- Diagnosis of type 2 diabetes mellitus prior to informed consent and an estimated glomerular filtration rate of 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.
Data sourced from ClinicalTrials.gov (NCT01164501). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.