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Completed

NCT Number: NCT01164501

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1245.36.20052 Boehringer Ingelheim Investigational Site, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BI 10773

Drug

BI 10773 tablets once daily

Placebo

Drug

Placebo tablets identical to BI 10773 low dose

Primary outcomes

  1. HbA1c Change From Baseline in Patients With Mild or Moderate Renal Impairment

    Time frame: Baseline and 24 weeks

    Change from baseline in HbA1c after 24 weeks, for patients with mild or moderate renal impairment.

    Note adjusted means are provided.

  2. HbA1c Change From Baseline in Patients With Mild Renal Impairment

    Time frame: Baseline and 24 weeks

    Change from baseline in HbA1c after 24 weeks, for patients with mild renal impairment.

    Note adjusted means are provided.

  3. HbA1c Change From Baseline in Patients With Moderate Renal Impairment

    Time frame: Baseline and 24 weeks

    Change from baseline in HbA1c after 24 weeks, for patients with moderate renal impairment.

    Note adjusted means are provided.

Other outcomes

  1. Hypoglycaemic Events

    Time frame: From first drug administration until 7 days after last trial medication intake, up to 458 days

    Percentage of patients who experienced a hypoglycaemic event. A hypoglycaemic event was regarded as confirmed if it was documented as an adverse event with plasma glucose values <= 70 mg/dL (<=3.9mmol/L) measured or with a documentation that the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative action had been required.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 16, 2010
Registry last updated
Jun 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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