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

May 16, 2014 updated by: Boehringer Ingelheim

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

741

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • 1245.36.20052 Boehringer Ingelheim Investigational Site
      • Calgary, Alberta, Canada
        • 1245.36.20054 Boehringer Ingelheim Investigational Site
      • Edmonton, Alberta, Canada
        • 1245.36.20023 Boehringer Ingelheim Investigational Site
      • Edmonton, Alberta, Canada
        • 1245.36.20055 Boehringer Ingelheim Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • 1245.36.20048 Boehringer Ingelheim Investigational Site
    • Ontario
      • Mississauga, Ontario, Canada
        • 1245.36.20051 Boehringer Ingelheim Investigational Site
      • Thornhill, Ontario, Canada
        • 1245.36.20086 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada
        • 1245.36.20053 Boehringer Ingelheim Investigational Site
    • Quebec
      • Montreal, Quebec, Canada
        • 1245.36.20056 Boehringer Ingelheim Investigational Site
  • France
      • Corbeil Essonnes, France
        • 1245.36.33001 Boehringer Ingelheim Investigational Site
      • Nanterre Cedex, France
        • 1245.36.33042 Boehringer Ingelheim Investigational Site
      • Nice, France
        • 1245.36.33041 Boehringer Ingelheim Investigational Site
      • Paris, France
        • 1245.36.33036 Boehringer Ingelheim Investigational Site
      • Poitiers, France
        • 1245.36.33040 Boehringer Ingelheim Investigational Site
      • Reims, France
        • 1245.36.33037 Boehringer Ingelheim Investigational Site
      • Reims Cedex, France
        • 1245.36.33038 Boehringer Ingelheim Investigational Site
      • Rennes, France
        • 1245.36.33043 Boehringer Ingelheim Investigational Site
      • Saint Mandé, France
        • 1245.36.33044 Boehringer Ingelheim Investigational Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • 1245.36.85201 Boehringer Ingelheim Investigational Site
      • Hong Kong, Hong Kong
        • 1245.36.85204 Boehringer Ingelheim Investigational Site
      • Hong Kong, Hong Kong
        • 1245.36.85205 Boehringer Ingelheim Investigational Site
      • Hong Kong, Hong Kong
        • 1245.36.85206 Boehringer Ingelheim Investigational Site
      • Kowloon, Hong Kong
        • 1245.36.85202 Boehringer Ingelheim Investigational Site
  • India
      • Aligarh, Uttar Pradesh, India
        • 1245.36.91209 Boehringer Ingelheim Investigational Site
      • Bangalore, India
        • 1245.36.91202 Boehringer Ingelheim Investigational Site
      • Bangalore, India
        • 1245.36.91204 Boehringer Ingelheim Investigational Site
      • Bangalore, India
        • 1245.36.91205 Boehringer Ingelheim Investigational Site
      • Bangalore, India
        • 1245.36.91208 Boehringer Ingelheim Investigational Site
      • Chennai, India
        • 1245.36.91201 Boehringer Ingelheim Investigational Site
      • Chennai, India
        • 1245.36.91214 Boehringer Ingelheim Investigational Site
      • Gurgaon, India
        • 1245.36.91213 Boehringer Ingelheim Investigational Site
      • Hyderabad, India
        • 1245.36.91203 Boehringer Ingelheim Investigational Site
      • Kolkata, India
        • 1245.36.91211 Boehringer Ingelheim Investigational Site
      • Mangalore, India
        • 1245.36.91210 Boehringer Ingelheim Investigational Site
      • Mumbai, Maharastra, India
        • 1245.36.91215 Boehringer Ingelheim Investigational Site
      • Nasik, India
        • 1245.36.91216 Boehringer Ingelheim Investigational Site
      • New Delhi, India
        • 1245.36.91212 Boehringer Ingelheim Investigational Site
      • Pune, India
        • 1245.36.91207 Boehringer Ingelheim Investigational Site
  • Malaysia
      • Johor Baru, Malaysia
        • 1245.36.60003 Boehringer Ingelheim Investigational Site
      • Kelantan Kota Bahru, Malaysia
        • 1245.36.60006 Boehringer Ingelheim Investigational Site
      • Kuala Lumpur, Malaysia
        • 1245.36.60005 Boehringer Ingelheim Investigational Site
      • Kuala Lumpur, Malaysia
        • 1245.36.60009 Boehringer Ingelheim Investigational Site
      • Pahang, Malaysia
        • 1245.36.60004 Boehringer Ingelheim Investigational Site
      • Perak, Malaysia
        • 1245.36.60007 Boehringer Ingelheim Investigational Site
      • Perak, Malaysia
        • 1245.36.60011 Boehringer Ingelheim Investigational Site
      • Pulau Piang, Malaysia
        • 1245.36.60010 Boehringer Ingelheim Investigational Site
      • Sabah, Malaysia
        • 1245.36.60008 Boehringer Ingelheim Investigational Site
      • Selangor Darul Ehsan, Malaysia
        • 1245.36.60001 Boehringer Ingelheim Investigational Site
  • Netherlands
      • Amersfoort, Netherlands
        • 1245.36.31015 Boehringer Ingelheim Investigational Site
      • Den Haag, Netherlands
        • 1245.36.31004 Boehringer Ingelheim Investigational Site
      • Geleen, Netherlands
        • 1245.36.31012 Boehringer Ingelheim Investigational Site
      • Hardenberg, Netherlands
        • 1245.36.31017 Boehringer Ingelheim Investigational Site
      • Maastricht, Netherlands
        • 1245.36.31009 Boehringer Ingelheim Investigational Site
      • Utrecht, Netherlands
        • 1245.36.31002 Boehringer Ingelheim Investigational Site
      • Zaandam, Netherlands
        • 1245.36.31003 Boehringer Ingelheim Investigational Site
  • Philippines
      • Cavite City, Philippines
        • 1245.36.63008 Boehringer Ingelheim Investigational Site
      • Cebu, Philippines
        • 1245.36.63006 Boehringer Ingelheim Investigational Site
      • Manila, Philippines
        • 1245.36.63005 Boehringer Ingelheim Investigational Site
      • Manila, Philippines
        • 1245.36.63007 Boehringer Ingelheim Investigational Site
      • Marikina, Philippines
        • 1245.36.63009 Boehringer Ingelheim Investigational Site
      • Tacloban, Philippines
        • 1245.36.63010 Boehringer Ingelheim Investigational Site
  • Poland
      • Gdansk, Poland
        • 1245.36.48006 Boehringer Ingelheim Investigational Site
      • Lodz, Poland
        • 1245.36.48003 Boehringer Ingelheim Investigational Site
      • Lodz, Poland
        • 1245.36.48004 Boehringer Ingelheim Investigational Site
      • Lublin, Poland
        • 1245.36.48001 Boehringer Ingelheim Investigational Site
      • Poznan, Poland
        • 1245.36.48002 Boehringer Ingelheim Investigational Site
      • Ruda Slaska, Poland
        • 1245.36.48007 Boehringer Ingelheim Investigational Site
      • Torun, Poland
        • 1245.36.48005 Boehringer Ingelheim Investigational Site
  • Portugal
      • Faro, Portugal
        • 1245.36.35003 Boehringer Ingelheim Investigational Site
      • Lisboa, Portugal
        • 1245.36.35002 Boehringer Ingelheim Investigational Site
      • Lisboa, Portugal
        • 1245.36.35004 Boehringer Ingelheim Investigational Site
      • Vila Nova de Gaia, Portugal
        • 1245.36.35001 Boehringer Ingelheim Investigational Site
  • Russian Federation
      • Moscow, Russian Federation
        • 1245.36.70008 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1245.36.70009 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1245.36.70011 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1245.36.70004 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1245.36.70006 Boehringer Ingelheim Investigational Site
      • Vsevolozhsk, Russian Federation
        • 1245.36.70002 Boehringer Ingelheim Investigational Site
  • Slovakia
      • Moldava nad Bodvou, Slovakia
        • 1245.36.74011 Boehringer Ingelheim Investigational Site
      • Nitra, Slovakia
        • 1245.36.74013 Boehringer Ingelheim Investigational Site
      • Nove Mesto Nad Vahom, Slovakia
        • 1245.36.74008 Boehringer Ingelheim Investigational Site
      • Presov, Slovakia
        • 1245.36.74012 Boehringer Ingelheim Investigational Site
      • Trencin, Slovakia
        • 1245.36.74007 Boehringer Ingelheim Investigational Site
      • Zilina, Slovakia
        • 1245.36.74009 Boehringer Ingelheim Investigational Site
  • South Africa
      • Plumstead, South Africa
        • 1245.36.76021 Boehringer Ingelheim Investigational Site
      • Somerset West, South Africa
        • 1245.36.76020 Boehringer Ingelheim Investigational Site
      • Somerset West, South Africa
        • 1245.36.76022 Boehringer Ingelheim Investigational Site
  • Spain
      • Barcelona, Spain
        • 1245.36.34015 Boehringer Ingelheim Investigational Site
      • Granada, Spain
        • 1245.36.34009 Boehringer Ingelheim Investigational Site
      • L'Hospitalet de Llobregat, Spain
        • 1245.36.34014 Boehringer Ingelheim Investigational Site
      • Madrid, Spain
        • 1245.36.34012 Boehringer Ingelheim Investigational Site
      • Madrid, Spain
        • 1245.36.34013 Boehringer Ingelheim Investigational Site
      • Manresa, Spain
        • 1245.36.34020 Boehringer Ingelheim Investigational Site
      • San Sebastian de los Reyes, Spain
        • 1245.36.34021 Boehringer Ingelheim Investigational Site
      • Santiago de Compostela, Spain
        • 1245.36.34016 Boehringer Ingelheim Investigational Site
      • Valencia, Spain
        • 1245.36.34017 Boehringer Ingelheim Investigational Site
      • Valencia, Spain
        • 1245.36.34019 Boehringer Ingelheim Investigational Site
  • United Kingdom
      • Bath, United Kingdom
        • 1245.36.44018 Boehringer Ingelheim Investigational Site
      • Birmingham, United Kingdom
        • 1245.36.44010 Boehringer Ingelheim Investigational Site
      • Blackpool, United Kingdom
        • 1245.36.44013 Boehringer Ingelheim Investigational Site
      • Blackpool, United Kingdom
        • 1245.36.44016 Boehringer Ingelheim Investigational Site
      • Chester, United Kingdom
        • 1245.36.44026 Boehringer Ingelheim Investigational Site
      • Chesterfield, United Kingdom
        • 1245.36.44012 Boehringer Ingelheim Investigational Site
      • Doncaster, United Kingdom
        • 1245.36.44025 Boehringer Ingelheim Investigational Site
      • Epsom, United Kingdom
        • 1245.36.44036 Boehringer Ingelheim Investigational Site
      • Frome, United Kingdom
        • 1245.36.44001 Boehringer Ingelheim Investigational Site
      • Midsomer Norton, United Kingdom
        • 1245.36.44007 Boehringer Ingelheim Investigational Site
      • Nantwich, United Kingdom
        • 1245.36.44023 Boehringer Ingelheim Investigational Site
      • Welwyn Garden City, United Kingdom
        • 1245.36.44024 Boehringer Ingelheim Investigational Site
  • United States
    • California
      • Anaheim, California, United States
        • 1245.36.10014 Boehringer Ingelheim Investigational Site
      • Lomita, California, United States
        • 1245.36.10019 Boehringer Ingelheim Investigational Site
    • Florida
      • Plantation, Florida, United States
        • 1245.36.10017 Boehringer Ingelheim Investigational Site
      • West Palm Beach, Florida, United States
        • 1245.36.10009 Boehringer Ingelheim Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States
        • 1245.36.10018 Boehringer Ingelheim Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States
        • 1245.36.10015 Boehringer Ingelheim Investigational Site
    • New York
      • Endwell, New York, United States
        • 1245.36.10021 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Greenville, North Carolina, United States
        • 1245.36.10008 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States
        • 1245.36.10005 Boehringer Ingelheim Investigational Site
      • Melrose Park, Pennsylvania, United States
        • 1245.36.10003 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Greer, South Carolina, United States
        • 1245.36.10004 Boehringer Ingelheim Investigational Site
    • Texas
      • Corpus Christi, Texas, United States
        • 1245.36.10012 Boehringer Ingelheim Investigational Site
      • Dallas, Texas, United States
        • 1245.36.10013 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 1245.36.10002 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 1245.36.10007 Boehringer Ingelheim Investigational Site
    • Washington
      • Renton, Washington, United States
        • 1245.36.10023 Boehringer Ingelheim Investigational Site
      • Spokane, Washington, United States
        • 1245.36.10011 Boehringer Ingelheim Investigational Site
      • Tacoma, Washington, United States
        • 1245.36.10006 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo tablets matching BI 10773
Drug: Placebo
Placebo tablets identical to BI 10773 low dose
Drug: Placebo
Placebo tablets identical to BI 10773 high dose
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 low dose
Drug: Placebo
Placebo tablets identical to BI 10773 high dose
Experimental: BI 10773 high dose
BI 10773 tablets once daily
Drug: BI 10773
BI 10773 tablets once daily
Drug: Placebo
Placebo tablets identical to BI 10773 low dose
Drug: Placebo
Placebo tablets identical to BI 10773 high dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 24 weeks
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.
Baseline and 24 weeks
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.
Baseline and 24 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From first drug administration until 7 days after last trial medication intake, up to 458 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Collaborators

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

July 15, 2010

First Submitted That Met QC Criteria

July 15, 2010

First Posted (Estimate)

July 16, 2010

Study Record Updates

Last Update Posted (Estimate)

June 16, 2014

Last Update Submitted That Met QC Criteria

May 16, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1245.36
  • 2009-016179-31 (EudraCT Number: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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