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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01164501
First received: July 15, 2010
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Renal Insufficiency
Drug: BI 10773
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • HbA1c Change From Baseline in Patients With Mild or Moderate Renal Impairment [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]

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

    Note adjusted means are provided.


  • HbA1c Change From Baseline in Patients With Mild Renal Impairment [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]

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

    Note adjusted means are provided.


  • HbA1c Change From Baseline in Patients With Moderate Renal Impairment [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]

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

    Note adjusted means are provided.



Other Outcome Measures:
  • Hypoglycaemic Events [ Time Frame: From first drug administration until 7 days after last trial medication intake, up to 458 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 741
Study Start Date: July 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 10773 low dose
BI 10773 tablets once daily
Drug: BI 10773
BI 10773 tablets once daily
Drug: Placebo
Placebo tablets identical to BI 10773 high dose
Experimental: BI 10773 high dose
BI 10773 tablets once daily
Drug: Placebo
Placebo tablets identical to BI 10773 low dose
Drug: BI 10773
BI 10773 tablets once daily
Placebo Comparator: Placebo
Placebo tablets matching BI 10773
Drug: Placebo
Placebo tablets identical to BI 10773 high dose
Drug: Placebo
Placebo tablets identical to BI 10773 low dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Diagnosis of type 2 diabetes mellitus prior to informed consent and an estimated glomerular filtration rate of <90 ml/min.
  2. 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.
  3. HbA1c greater than or equal to 7.0% and less than or equal to 10.0% .
  4. Aged 18 years or above.
  5. Body Mass Index less than or equal to 45 kg/m2

Exclusion criteria:

  1. Uncontrolled hyperglycaemia defined as >13.3 mmol/L after an overnight fast during placebo run-in.
  2. Impaired renal function, defined as an estimated glomerular filtration rate <15 ml/min.
  3. Renal impairment requiring any form of chronic dialysis.
  4. Requiring acute dialysis within three months prior to informed consent.
  5. Renal transplant recipient.
  6. Myocardial infarction, stroke or Transient Ischemic Attack within three months prior to informed consent.
  7. Indication of liver disease.
  8. Bariatric surgery within the past two years.
  9. Medical history of cancer.
  10. Blood dyscrasias or any disorders causing hemolysis or unstable red blood cell.
  11. Contraindications to pre-existing background antidiabetic therapy.
  12. Treatment with anti-obesity drugs.
  13. 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.
  14. Pre-menopausal women who are nursing or pregnant or are of child-bearing potential and are not practising an acceptable method of birth control.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01164501

  Show 127 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01164501     History of Changes
Other Study ID Numbers: 1245.36, 2009-016179-31
Study First Received: July 15, 2010
Results First Received: May 16, 2014
Last Updated: May 16, 2014
Health Authority: Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hong Kong: Department of Health
India: Drugs Controller General of India
Malaysia: Ministry of Health
Netherlands: Central Committee Research Involving Human Subjects
Philippines: Bureau of Food and Drugs
Poland: Registration Medicinal Product Medical Device Biocidal Product
Portugal: National Pharmacy and Medicines Institute
Russia: Pharmacological Committee, Ministry of Health
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Endocrine System Diseases
Glucose Metabolism Disorders
Kidney Diseases
Metabolic Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on November 20, 2014