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

Primary Purpose

Diabetes Mellitus, Type 2, Renal Insufficiency

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BI 10773
Placebo
Placebo
BI 10773
Placebo
Placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • 1245.36.10014 Boehringer Ingelheim Investigational Site
  • 1245.36.10019 Boehringer Ingelheim Investigational Site
  • 1245.36.10017 Boehringer Ingelheim Investigational Site
  • 1245.36.10009 Boehringer Ingelheim Investigational Site
  • 1245.36.10018 Boehringer Ingelheim Investigational Site
  • 1245.36.10015 Boehringer Ingelheim Investigational Site
  • 1245.36.10021 Boehringer Ingelheim Investigational Site
  • 1245.36.10008 Boehringer Ingelheim Investigational Site
  • 1245.36.10005 Boehringer Ingelheim Investigational Site
  • 1245.36.10003 Boehringer Ingelheim Investigational Site
  • 1245.36.10004 Boehringer Ingelheim Investigational Site
  • 1245.36.10012 Boehringer Ingelheim Investigational Site
  • 1245.36.10013 Boehringer Ingelheim Investigational Site
  • 1245.36.10002 Boehringer Ingelheim Investigational Site
  • 1245.36.10007 Boehringer Ingelheim Investigational Site
  • 1245.36.10023 Boehringer Ingelheim Investigational Site
  • 1245.36.10011 Boehringer Ingelheim Investigational Site
  • 1245.36.10006 Boehringer Ingelheim Investigational Site
  • 1245.36.20052 Boehringer Ingelheim Investigational Site
  • 1245.36.20054 Boehringer Ingelheim Investigational Site
  • 1245.36.20023 Boehringer Ingelheim Investigational Site
  • 1245.36.20055 Boehringer Ingelheim Investigational Site
  • 1245.36.20048 Boehringer Ingelheim Investigational Site
  • 1245.36.20051 Boehringer Ingelheim Investigational Site
  • 1245.36.20086 Boehringer Ingelheim Investigational Site
  • 1245.36.20053 Boehringer Ingelheim Investigational Site
  • 1245.36.20056 Boehringer Ingelheim Investigational Site
  • 1245.36.33001 Boehringer Ingelheim Investigational Site
  • 1245.36.33042 Boehringer Ingelheim Investigational Site
  • 1245.36.33041 Boehringer Ingelheim Investigational Site
  • 1245.36.33036 Boehringer Ingelheim Investigational Site
  • 1245.36.33040 Boehringer Ingelheim Investigational Site
  • 1245.36.33038 Boehringer Ingelheim Investigational Site
  • 1245.36.33037 Boehringer Ingelheim Investigational Site
  • 1245.36.33043 Boehringer Ingelheim Investigational Site
  • 1245.36.33044 Boehringer Ingelheim Investigational Site
  • 1245.36.85201 Boehringer Ingelheim Investigational Site
  • 1245.36.85204 Boehringer Ingelheim Investigational Site
  • 1245.36.85205 Boehringer Ingelheim Investigational Site
  • 1245.36.85206 Boehringer Ingelheim Investigational Site
  • 1245.36.85202 Boehringer Ingelheim Investigational Site
  • 1245.36.91209 Boehringer Ingelheim Investigational Site
  • 1245.36.91202 Boehringer Ingelheim Investigational Site
  • 1245.36.91204 Boehringer Ingelheim Investigational Site
  • 1245.36.91205 Boehringer Ingelheim Investigational Site
  • 1245.36.91208 Boehringer Ingelheim Investigational Site
  • 1245.36.91201 Boehringer Ingelheim Investigational Site
  • 1245.36.91214 Boehringer Ingelheim Investigational Site
  • 1245.36.91213 Boehringer Ingelheim Investigational Site
  • 1245.36.91203 Boehringer Ingelheim Investigational Site
  • 1245.36.91211 Boehringer Ingelheim Investigational Site
  • 1245.36.91210 Boehringer Ingelheim Investigational Site
  • 1245.36.91215 Boehringer Ingelheim Investigational Site
  • 1245.36.91216 Boehringer Ingelheim Investigational Site
  • 1245.36.91212 Boehringer Ingelheim Investigational Site
  • 1245.36.91207 Boehringer Ingelheim Investigational Site
  • 1245.36.60003 Boehringer Ingelheim Investigational Site
  • 1245.36.60006 Boehringer Ingelheim Investigational Site
  • 1245.36.60005 Boehringer Ingelheim Investigational Site
  • 1245.36.60009 Boehringer Ingelheim Investigational Site
  • 1245.36.60004 Boehringer Ingelheim Investigational Site
  • 1245.36.60007 Boehringer Ingelheim Investigational Site
  • 1245.36.60011 Boehringer Ingelheim Investigational Site
  • 1245.36.60010 Boehringer Ingelheim Investigational Site
  • 1245.36.60008 Boehringer Ingelheim Investigational Site
  • 1245.36.60001 Boehringer Ingelheim Investigational Site
  • 1245.36.31015 Boehringer Ingelheim Investigational Site
  • 1245.36.31004 Boehringer Ingelheim Investigational Site
  • 1245.36.31012 Boehringer Ingelheim Investigational Site
  • 1245.36.31017 Boehringer Ingelheim Investigational Site
  • 1245.36.31009 Boehringer Ingelheim Investigational Site
  • 1245.36.31002 Boehringer Ingelheim Investigational Site
  • 1245.36.31003 Boehringer Ingelheim Investigational Site
  • 1245.36.63008 Boehringer Ingelheim Investigational Site
  • 1245.36.63006 Boehringer Ingelheim Investigational Site
  • 1245.36.63005 Boehringer Ingelheim Investigational Site
  • 1245.36.63007 Boehringer Ingelheim Investigational Site
  • 1245.36.63009 Boehringer Ingelheim Investigational Site
  • 1245.36.63010 Boehringer Ingelheim Investigational Site
  • 1245.36.48006 Boehringer Ingelheim Investigational Site
  • 1245.36.48003 Boehringer Ingelheim Investigational Site
  • 1245.36.48004 Boehringer Ingelheim Investigational Site
  • 1245.36.48001 Boehringer Ingelheim Investigational Site
  • 1245.36.48002 Boehringer Ingelheim Investigational Site
  • 1245.36.48007 Boehringer Ingelheim Investigational Site
  • 1245.36.48005 Boehringer Ingelheim Investigational Site
  • 1245.36.35003 Boehringer Ingelheim Investigational Site
  • 1245.36.35002 Boehringer Ingelheim Investigational Site
  • 1245.36.35004 Boehringer Ingelheim Investigational Site
  • 1245.36.35001 Boehringer Ingelheim Investigational Site
  • 1245.36.70008 Boehringer Ingelheim Investigational Site
  • 1245.36.70009 Boehringer Ingelheim Investigational Site
  • 1245.36.70011 Boehringer Ingelheim Investigational Site
  • 1245.36.70004 Boehringer Ingelheim Investigational Site
  • 1245.36.70006 Boehringer Ingelheim Investigational Site
  • 1245.36.70002 Boehringer Ingelheim Investigational Site
  • 1245.36.74011 Boehringer Ingelheim Investigational Site
  • 1245.36.74013 Boehringer Ingelheim Investigational Site
  • 1245.36.74008 Boehringer Ingelheim Investigational Site
  • 1245.36.74012 Boehringer Ingelheim Investigational Site
  • 1245.36.74007 Boehringer Ingelheim Investigational Site
  • 1245.36.74009 Boehringer Ingelheim Investigational Site
  • 1245.36.76021 Boehringer Ingelheim Investigational Site
  • 1245.36.76020 Boehringer Ingelheim Investigational Site
  • 1245.36.76022 Boehringer Ingelheim Investigational Site
  • 1245.36.34015 Boehringer Ingelheim Investigational Site
  • 1245.36.34009 Boehringer Ingelheim Investigational Site
  • 1245.36.34014 Boehringer Ingelheim Investigational Site
  • 1245.36.34012 Boehringer Ingelheim Investigational Site
  • 1245.36.34013 Boehringer Ingelheim Investigational Site
  • 1245.36.34020 Boehringer Ingelheim Investigational Site
  • 1245.36.34021 Boehringer Ingelheim Investigational Site
  • 1245.36.34016 Boehringer Ingelheim Investigational Site
  • 1245.36.34017 Boehringer Ingelheim Investigational Site
  • 1245.36.34019 Boehringer Ingelheim Investigational Site
  • 1245.36.44018 Boehringer Ingelheim Investigational Site
  • 1245.36.44010 Boehringer Ingelheim Investigational Site
  • 1245.36.44013 Boehringer Ingelheim Investigational Site
  • 1245.36.44016 Boehringer Ingelheim Investigational Site
  • 1245.36.44012 Boehringer Ingelheim Investigational Site
  • 1245.36.44026 Boehringer Ingelheim Investigational Site
  • 1245.36.44025 Boehringer Ingelheim Investigational Site
  • 1245.36.44036 Boehringer Ingelheim Investigational Site
  • 1245.36.44001 Boehringer Ingelheim Investigational Site
  • 1245.36.44007 Boehringer Ingelheim Investigational Site
  • 1245.36.44023 Boehringer Ingelheim Investigational Site
  • 1245.36.44024 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

BI 10773 low dose

BI 10773 high dose

Placebo

Arm Description

BI 10773 tablets once daily

BI 10773 tablets once daily

Placebo tablets matching BI 10773

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 15, 2010
Last Updated
May 16, 2014
Sponsor
Boehringer Ingelheim
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT01164501
Brief Title
Efficacy and Safety of Empagliflozin (BI 10773) in Patients With Type 2 Diabetes and Renal Impairment
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
Collaborators
Eli Lilly and Company

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Renal Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
741 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BI 10773 low dose
Arm Type
Experimental
Arm Description
BI 10773 tablets once daily
Arm Title
BI 10773 high dose
Arm Type
Experimental
Arm Description
BI 10773 tablets once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets matching BI 10773
Intervention Type
Drug
Intervention Name(s)
BI 10773
Intervention Description
BI 10773 tablets once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets identical to BI 10773 low dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets identical to BI 10773 high dose
Intervention Type
Drug
Intervention Name(s)
BI 10773
Intervention Description
BI 10773 tablets once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets identical to BI 10773 low dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets identical to BI 10773 high dose
Primary Outcome Measure Information:
Title
HbA1c Change From Baseline in Patients With Mild or Moderate Renal Impairment
Description
Change from baseline in HbA1c after 24 weeks, for patients with mild or moderate renal impairment. Note adjusted means are provided.
Time Frame
Baseline and 24 weeks
Title
HbA1c Change From Baseline in Patients With Mild Renal Impairment
Description
Change from baseline in HbA1c after 24 weeks, for patients with mild renal impairment. Note adjusted means are provided.
Time Frame
Baseline and 24 weeks
Title
HbA1c Change From Baseline in Patients With Moderate Renal Impairment
Description
Change from baseline in HbA1c after 24 weeks, for patients with moderate renal impairment. Note adjusted means are provided.
Time Frame
Baseline and 24 weeks
Other Pre-specified Outcome Measures:
Title
Hypoglycaemic Events
Description
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.
Time Frame
From first drug administration until 7 days after last trial medication intake, up to 458 days

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
35472672
Citation
Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.
Results Reference
derived
PubMed Identifier
27316632
Citation
Cherney D, Lund SS, Perkins BA, Groop PH, Cooper ME, Kaspers S, Pfarr E, Woerle HJ, von Eynatten M. The effect of sodium glucose cotransporter 2 inhibition with empagliflozin on microalbuminuria and macroalbuminuria in patients with type 2 diabetes. Diabetologia. 2016 Sep;59(9):1860-70. doi: 10.1007/s00125-016-4008-2. Epub 2016 Jun 17.
Results Reference
derived
PubMed Identifier
24795251
Citation
Barnett AH, Mithal A, Manassie J, Jones R, Rattunde H, Woerle HJ, Broedl UC; EMPA-REG RENAL trial investigators. Efficacy and safety of empagliflozin added to existing antidiabetes treatment in patients with type 2 diabetes and chronic kidney disease: a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2014 May;2(5):369-84. doi: 10.1016/S2213-8587(13)70208-0. Epub 2014 Jan 24.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1245/1245.36_U12-1522-01-DS.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1245/1245.36_Literature.pdf
Description
Related Info

Learn more about this trial

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

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