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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg and 25 mg Administered Once Daily) as Add on to Pre-existing Antidiabetic Therapy Over 52 Weeks in Patients With Type 2 Diabetes Mellitus and Renal Impairment and Insufficient Glycaemic Control

Conditions
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Diabetes Mellitus, Type 2, Renal Insufficiency

Intervention / Treatment
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* Drug: BI 10773
* Drug: Placebo
* Drug: Placebo
* Drug: BI 10773
* Drug: Placebo
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 10773 low dose<br>BI 10773 tablets once daily | Drug: BI 10773<br>* BI 10773 tablets once daily<br>Drug: Placebo<br>* Placebo tablets identical to BI 10773 high dose<br>|
| Experimental: BI 10773 high dose<br>BI 10773 tablets once daily | Drug: Placebo<br>* Placebo tablets identical to BI 10773 low dose<br>Drug: BI 10773<br>* BI 10773 tablets once daily<br>|
| Placebo Comparator: Placebo<br>Placebo tablets matching BI 10773 | Drug: Placebo<br>* Placebo tablets identical to BI 10773 high dose<br>Drug: Placebo<br>* Placebo tablets identical to BI 10773 low dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c Change From Baseline in Patients With Mild or Moderate Renal Impairment | Change from baseline in HbA1c after 24 weeks, for patients with mild or moderate renal impairment. Note adjusted means are provided. | Baseline and 24 weeks | 
| HbA1c Change From Baseline in Patients With Mild Renal Impairment | Change from baseline in HbA1c after 24 weeks, for patients with mild renal impairment. Note adjusted means are provided. | Baseline and 24 weeks | 
| HbA1c Change From Baseline in Patients With Moderate Renal Impairment | Change from baseline in HbA1c after 24 weeks, for patients with moderate renal impairment. Note adjusted means are provided. | Baseline and 24 weeks |