search
Back to results

A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Placebo
Placebo
Placebo
Placebo
empagliflozin (low dose qd)
Placebo
Placebo
Placebo
Placebo
Placebo
Placebo
Placebo
Placebo
Placebo
Placebo
Empagliflozin (high dose qd)
empagliflozin (high dose bid)
Placebo
empagliflozin (low dose bid)
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. confirmed diagnosis of T2DM
  2. Glycated hemoglobin (HbA1c) >=7.0 and <=10/0% at Visit 1
  3. Metformin therapy (at least 1500 mg/day, BID)
  4. age>=18 at Visit 1
  5. body mass index <=45 kg/m2

Exclusion criteria:

  1. estimated creatinine clearance rate (eCCr) <60 ml/min (Cockcroft-Gault formula) screening and/or run-in
  2. a confirmed glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in

Sites / Locations

  • 1276.10.11036 Boehringer Ingelheim Investigational Site
  • 1276.10.11049 Boehringer Ingelheim Investigational Site
  • 1276.10.11040 Boehringer Ingelheim Investigational Site
  • 1276.10.11033 Boehringer Ingelheim Investigational Site
  • 1276.10.11002 Boehringer Ingelheim Investigational Site
  • 1276.10.11050 Boehringer Ingelheim Investigational Site
  • 1276.10.11015 Boehringer Ingelheim Investigational Site
  • 1276.10.11012 Boehringer Ingelheim Investigational Site
  • 1276.10.11047 Boehringer Ingelheim Investigational Site
  • 1276.10.11010 Boehringer Ingelheim Investigational Site
  • 1276.10.11005 Boehringer Ingelheim Investigational Site
  • 1276.10.11004 Boehringer Ingelheim Investigational Site
  • 1276.10.11051 Boehringer Ingelheim Investigational Site
  • 1276.10.11009 Boehringer Ingelheim Investigational Site
  • 1276.10.11044 Boehringer Ingelheim Investigational Site
  • 1276.10.11030 Boehringer Ingelheim Investigational Site
  • 1276.10.11027 Boehringer Ingelheim Investigational Site
  • 1276.10.11020 Boehringer Ingelheim Investigational Site
  • 1276.10.11001 Boehringer Ingelheim Investigational Site
  • 1276.10.11048 Boehringer Ingelheim Investigational Site
  • 1276.10.11058 Boehringer Ingelheim Investigational Site
  • 1276.10.11055 Boehringer Ingelheim Investigational Site
  • 1276.10.11011 Boehringer Ingelheim Investigational Site
  • 1276.10.11035 Boehringer Ingelheim Investigational Site
  • 1276.10.11041 Boehringer Ingelheim Investigational Site
  • 1276.10.11018 Boehringer Ingelheim Investigational Site
  • 1276.10.11043 Boehringer Ingelheim Investigational Site
  • 1276.10.11017 Boehringer Ingelheim Investigational Site
  • 1276.10.11022 Boehringer Ingelheim Investigational Site
  • 1276.10.11003 Boehringer Ingelheim Investigational Site
  • 1276.10.11042 Boehringer Ingelheim Investigational Site
  • 1276.10.11013 Boehringer Ingelheim Investigational Site
  • 1276.10.11026 Boehringer Ingelheim Investigational Site
  • 1276.10.11031 Boehringer Ingelheim Investigational Site
  • 1276.10.11034 Boehringer Ingelheim Investigational Site
  • 1276.10.11028 Boehringer Ingelheim Investigational Site
  • 1276.10.11029 Boehringer Ingelheim Investigational Site
  • 1276.10.11016 Boehringer Ingelheim Investigational Site
  • 1276.10.11024 Boehringer Ingelheim Investigational Site
  • 1276.10.61002 Boehringer Ingelheim Investigational Site
  • 1276.10.61001 Boehringer Ingelheim Investigational Site
  • 1276.10.20008 Boehringer Ingelheim Investigational Site
  • 1276.10.20005 Boehringer Ingelheim Investigational Site
  • 1276.10.20010 Boehringer Ingelheim Investigational Site
  • 1276.10.20002 Boehringer Ingelheim Investigational Site
  • 1276.10.20001 Boehringer Ingelheim Investigational Site
  • 1276.10.20007 Boehringer Ingelheim Investigational Site
  • 1276.10.20006 Boehringer Ingelheim Investigational Site
  • 1276.10.20004 Boehringer Ingelheim Investigational Site
  • 1276.10.20003 Boehringer Ingelheim Investigational Site
  • 1276.10.20009 Boehringer Ingelheim Investigational Site
  • 1276.10.37203 Boehringer Ingelheim Investigational Site
  • 1276.10.37201 Boehringer Ingelheim Investigational Site
  • 1276.10.37202 Boehringer Ingelheim Investigational Site
  • 1276.10.37204 Boehringer Ingelheim Investigational Site
  • 1276.10.33002 Boehringer Ingelheim Investigational Site
  • 1276.10.33003 Boehringer Ingelheim Investigational Site
  • 1276.10.33009 Boehringer Ingelheim Investigational Site
  • 1276.10.33014 Boehringer Ingelheim Investigational Site
  • 1276.10.33007 Boehringer Ingelheim Investigational Site
  • 1276.10.33001 Boehringer Ingelheim Investigational Site
  • 1276.10.33008 Boehringer Ingelheim Investigational Site
  • 1276.10.33006 Boehringer Ingelheim Investigational Site
  • 1276.10.33011 Boehringer Ingelheim Investigational Site
  • 1276.10.33004 Boehringer Ingelheim Investigational Site
  • 1276.10.99501 Boehringer Ingelheim Investigational Site
  • 1276.10.99502 Boehringer Ingelheim Investigational Site
  • 1276.10.99503 Boehringer Ingelheim Investigational Site
  • 1276.10.99504 Boehringer Ingelheim Investigational Site
  • 1276.10.99505 Boehringer Ingelheim Investigational Site
  • 1276.10.99506 Boehringer Ingelheim Investigational Site
  • 1276.10.49001 Boehringer Ingelheim Investigational Site
  • 1276.10.49006 Boehringer Ingelheim Investigational Site
  • 1276.10.49007 Boehringer Ingelheim Investigational Site
  • 1276.10.49005 Boehringer Ingelheim Investigational Site
  • 1276.10.49004 Boehringer Ingelheim Investigational Site
  • 1276.10.49002 Boehringer Ingelheim Investigational Site
  • 1276.10.49003 Boehringer Ingelheim Investigational Site
  • 1276.10.50201 Boehringer Ingelheim Investigational Site
  • 1276.10.50203 Boehringer Ingelheim Investigational Site
  • 1276.10.50204 Boehringer Ingelheim Investigational Site
  • 1276.10.50205 Boehringer Ingelheim Investigational Site
  • 1276.10.50202 Boehringer Ingelheim Investigational Site
  • 1276.10.39004 Boehringer Ingelheim Investigational Site
  • 1276.10.39003 Boehringer Ingelheim Investigational Site
  • 1276.10.39007 Boehringer Ingelheim Investigational Site
  • 1276.10.39009 Boehringer Ingelheim Investigational Site
  • 1276.10.39002 Boehringer Ingelheim Investigational Site
  • 1276.10.39006 Boehringer Ingelheim Investigational Site
  • 1276.10.39001 Boehringer Ingelheim Investigational Site
  • 1276.10.39008 Boehringer Ingelheim Investigational Site
  • 1276.10.39005 Boehringer Ingelheim Investigational Site
  • 1276.10.37102 Boehringer Ingelheim Investigational Site
  • 1276.10.37104 Boehringer Ingelheim Investigational Site
  • 1276.10.37101 Boehringer Ingelheim Investigational Site
  • 1276.10.37103 Boehringer Ingelheim Investigational Site
  • 1276.10.37003 Boehringer Ingelheim Investigational Site
  • 1276.10.37004 Boehringer Ingelheim Investigational Site
  • 1276.10.37002 Boehringer Ingelheim Investigational Site
  • 1276.10.37001 Boehringer Ingelheim Investigational Site
  • 1276.10.52001 Boehringer Ingelheim Investigational Site
  • 1276.10.52002 Boehringer Ingelheim Investigational Site
  • 1276.10.52003 Boehringer Ingelheim Investigational Site
  • 1276.10.52005 Boehringer Ingelheim Investigational Site
  • 1276.10.52004 Boehringer Ingelheim Investigational Site
  • 1276.10.64001 Boehringer Ingelheim Investigational Site
  • 1276.10.64002 Boehringer Ingelheim Investigational Site
  • 1276.10.48001 Boehringer Ingelheim Investigational Site
  • 1276.10.48002 Boehringer Ingelheim Investigational Site
  • 1276.10.48008 Boehringer Ingelheim Investigational Site
  • 1276.10.48005 Boehringer Ingelheim Investigational Site
  • 1276.10.48006 Boehringer Ingelheim Investigational Site
  • 1276.10.48004 Boehringer Ingelheim Investigational Site
  • 1276.10.48003 Boehringer Ingelheim Investigational Site
  • 1276.10.70001 Boehringer Ingelheim Investigational Site
  • 1276.10.70002 Boehringer Ingelheim Investigational Site
  • 1276.10.70003 Boehringer Ingelheim Investigational Site
  • 1276.10.70004 Boehringer Ingelheim Investigational Site
  • 1276.10.70005 Boehringer Ingelheim Investigational Site
  • 1276.10.70007 Boehringer Ingelheim Investigational Site
  • 1276.10.70008 Boehringer Ingelheim Investigational Site
  • 1276.10.70009 Boehringer Ingelheim Investigational Site
  • 1276.10.27004 Boehringer Ingelheim Investigational Site
  • 1276.10.27003 Boehringer Ingelheim Investigational Site
  • 1276.10.27006 Boehringer Ingelheim Investigational Site
  • 1276.10.27001 Boehringer Ingelheim Investigational Site
  • 1276.10.27005 Boehringer Ingelheim Investigational Site
  • 1276.10.27002 Boehringer Ingelheim Investigational Site
  • 1276.10.34005 Boehringer Ingelheim Investigational Site
  • 1276.10.34001 Boehringer Ingelheim Investigational Site
  • 1276.10.34003 Boehringer Ingelheim Investigational Site
  • 1276.10.34002 Boehringer Ingelheim Investigational Site
  • 1276.10.34004 Boehringer Ingelheim Investigational Site
  • 1276.10.34006 Boehringer Ingelheim Investigational Site
  • 1276.10.38002 Boehringer Ingelheim Investigational Site
  • 1276.10.38007 Boehringer Ingelheim Investigational Site
  • 1276.10.38001 Boehringer Ingelheim Investigational Site
  • 1276.10.38004 Boehringer Ingelheim Investigational Site
  • 1276.10.38005 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

empagliflozin (high dose qd)

empagliflozin (high dose bid)

empagliflozin (low dose qd)

empagliflozin (low dose bid)

Placebo

Arm Description

Patients receive Empagliflozin high dose once daily

Patients receive Empagliflozin high dose split twice daily

Patients receive Empagliflozin low dose once daily

Patients receive Empagliflozin low dose split twice daily

Patients receive placebo matching Empagliflozin

Outcomes

Primary Outcome Measures

HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16
Change from baseline in HbA1c (%) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication. Means provided are the adjusted means.

Secondary Outcome Measures

Fasting Plasma Glucose (FPG) Change From Baseline at Week 16
Change from baseline in FPG (mg/dL) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication. Means provided are the adjusted means.

Full Information

First Posted
July 23, 2012
Last Updated
June 26, 2015
Sponsor
Boehringer Ingelheim
Collaborators
Eli Lilly and Company
search

1. Study Identification

Unique Protocol Identification Number
NCT01649297
Brief Title
A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy
Official Title
A Randomised, Double Blind, Placebo Controlled, Parallel Group Efficacy and Safety Study of Oral Administration of Empagliflozin Twice Daily Versus Once Daily in Two Different Daily Doses Over 16 Weeks as add-on Therapy to a Twice Daily Dosing Regimen of Metformin in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (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
The aim of this study is to investigate the efficacy and safety of two doses (high and low) of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose once daily or split vs. low dose once daily or split). This is done to evaluate whether a twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once daily dosing when given on top of metformin background therapy.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
983 (Actual)

8. Arms, Groups, and Interventions

Arm Title
empagliflozin (high dose qd)
Arm Type
Experimental
Arm Description
Patients receive Empagliflozin high dose once daily
Arm Title
empagliflozin (high dose bid)
Arm Type
Experimental
Arm Description
Patients receive Empagliflozin high dose split twice daily
Arm Title
empagliflozin (low dose qd)
Arm Type
Experimental
Arm Description
Patients receive Empagliflozin low dose once daily
Arm Title
empagliflozin (low dose bid)
Arm Type
Experimental
Arm Description
Patients receive Empagliflozin low dose split twice daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients receive placebo matching Empagliflozin
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients receive placebo matching empagliflozin (low dose qd)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients receive placebo matching empagliflozin (low dose bid)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients receive placebo matching Empagliflozin (high dose qd)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients receive placebo matching Empagliflozin (high dose qd)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients receive placebo matching Empagliflozin (high dose qd)
Intervention Type
Drug
Intervention Name(s)
empagliflozin (low dose qd)
Intervention Description
Patients receive Empagliflozin low dose once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients receive placebo matching empagliflozin (low dose qd)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients receive placebo matching empagliflozin (low dose bid)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients receive placebo matching Empagliflozin (high dose bid)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients receive placebo matching Empagliflozin (high dose bid)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients receive placebo matching empagliflozin (low dose qd)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients receive placebo matching empagliflozin (low dose bid)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients receive placebo matching Empagliflozin (high dose bid)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients receive placebo matching empagliflozin (low dose qd)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients receive placebo matching empagliflozin (low dose bid)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients receive placebo matching Empagliflozin (high dose bid)
Intervention Type
Drug
Intervention Name(s)
Empagliflozin (high dose qd)
Intervention Description
Patients receive Empagliflozin high dose once daily
Intervention Type
Drug
Intervention Name(s)
empagliflozin (high dose bid)
Intervention Description
Patients receive Empagliflozin high dose split twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients receive placebo matching Empagliflozin (high dose qd)
Intervention Type
Drug
Intervention Name(s)
empagliflozin (low dose bid)
Intervention Description
Patients receive Empagliflozin low dose split twice daily
Primary Outcome Measure Information:
Title
HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16
Description
Change from baseline in HbA1c (%) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication. Means provided are the adjusted means.
Time Frame
Baseline and 16 weeks
Secondary Outcome Measure Information:
Title
Fasting Plasma Glucose (FPG) Change From Baseline at Week 16
Description
Change from baseline in FPG (mg/dL) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication. Means provided are the adjusted means.
Time Frame
Baseline and 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: confirmed diagnosis of T2DM Glycated hemoglobin (HbA1c) >=7.0 and <=10/0% at Visit 1 Metformin therapy (at least 1500 mg/day, BID) age>=18 at Visit 1 body mass index <=45 kg/m2 Exclusion criteria: estimated creatinine clearance rate (eCCr) <60 ml/min (Cockcroft-Gault formula) screening and/or run-in a confirmed glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in
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
1276.10.11036 Boehringer Ingelheim Investigational Site
City
Florence
State/Province
Alabama
Country
United States
Facility Name
1276.10.11049 Boehringer Ingelheim Investigational Site
City
Jonesboro
State/Province
Arkansas
Country
United States
Facility Name
1276.10.11040 Boehringer Ingelheim Investigational Site
City
Lomita
State/Province
California
Country
United States
Facility Name
1276.10.11033 Boehringer Ingelheim Investigational Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
1276.10.11002 Boehringer Ingelheim Investigational Site
City
Rancho Cucamonga
State/Province
California
Country
United States
Facility Name
1276.10.11050 Boehringer Ingelheim Investigational Site
City
Sacramento
State/Province
California
Country
United States
Facility Name
1276.10.11015 Boehringer Ingelheim Investigational Site
City
West Hills
State/Province
California
Country
United States
Facility Name
1276.10.11012 Boehringer Ingelheim Investigational Site
City
Norwalk
State/Province
Connecticut
Country
United States
Facility Name
1276.10.11047 Boehringer Ingelheim Investigational Site
City
Waterbury
State/Province
Connecticut
Country
United States
Facility Name
1276.10.11010 Boehringer Ingelheim Investigational Site
City
Bradenton
State/Province
Florida
Country
United States
Facility Name
1276.10.11005 Boehringer Ingelheim Investigational Site
City
Davie
State/Province
Florida
Country
United States
Facility Name
1276.10.11004 Boehringer Ingelheim Investigational Site
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
1276.10.11051 Boehringer Ingelheim Investigational Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
1276.10.11009 Boehringer Ingelheim Investigational Site
City
Oakland Park
State/Province
Florida
Country
United States
Facility Name
1276.10.11044 Boehringer Ingelheim Investigational Site
City
Palm Harbor
State/Province
Florida
Country
United States
Facility Name
1276.10.11030 Boehringer Ingelheim Investigational Site
City
Dunwoody
State/Province
Georgia
Country
United States
Facility Name
1276.10.11027 Boehringer Ingelheim Investigational Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
1276.10.11020 Boehringer Ingelheim Investigational Site
City
Elwood
State/Province
Indiana
Country
United States
Facility Name
1276.10.11001 Boehringer Ingelheim Investigational Site
City
Bangor
State/Province
Maine
Country
United States
Facility Name
1276.10.11048 Boehringer Ingelheim Investigational Site
City
Sterling Heights
State/Province
Michigan
Country
United States
Facility Name
1276.10.11058 Boehringer Ingelheim Investigational Site
City
Jackson
State/Province
Mississippi
Country
United States
Facility Name
1276.10.11055 Boehringer Ingelheim Investigational Site
City
Edison
State/Province
New Jersey
Country
United States
Facility Name
1276.10.11011 Boehringer Ingelheim Investigational Site
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
1276.10.11035 Boehringer Ingelheim Investigational Site
City
North Myrtle Beach
State/Province
North Carolina
Country
United States
Facility Name
1276.10.11041 Boehringer Ingelheim Investigational Site
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
1276.10.11018 Boehringer Ingelheim Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
1276.10.11043 Boehringer Ingelheim Investigational Site
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
1276.10.11017 Boehringer Ingelheim Investigational Site
City
Kettering
State/Province
Ohio
Country
United States
Facility Name
1276.10.11022 Boehringer Ingelheim Investigational Site
City
Fleetwood
State/Province
Pennsylvania
Country
United States
Facility Name
1276.10.11003 Boehringer Ingelheim Investigational Site
City
Johnson City
State/Province
Tennessee
Country
United States
Facility Name
1276.10.11042 Boehringer Ingelheim Investigational Site
City
Corpus Christi
State/Province
Texas
Country
United States
Facility Name
1276.10.11013 Boehringer Ingelheim Investigational Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
1276.10.11026 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1276.10.11031 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1276.10.11034 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1276.10.11028 Boehringer Ingelheim Investigational Site
City
Pearland
State/Province
Texas
Country
United States
Facility Name
1276.10.11029 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
1276.10.11016 Boehringer Ingelheim Investigational Site
City
Port Orchard
State/Province
Washington
Country
United States
Facility Name
1276.10.11024 Boehringer Ingelheim Investigational Site
City
Spokane
State/Province
Washington
Country
United States
Facility Name
1276.10.61002 Boehringer Ingelheim Investigational Site
City
Wollongong
State/Province
New South Wales
Country
Australia
Facility Name
1276.10.61001 Boehringer Ingelheim Investigational Site
City
Box Hill
State/Province
Victoria
Country
Australia
Facility Name
1276.10.20008 Boehringer Ingelheim Investigational Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
1276.10.20005 Boehringer Ingelheim Investigational Site
City
Surrey
State/Province
British Columbia
Country
Canada
Facility Name
1276.10.20010 Boehringer Ingelheim Investigational Site
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
1276.10.20002 Boehringer Ingelheim Investigational Site
City
Bathurst
State/Province
New Brunswick
Country
Canada
Facility Name
1276.10.20001 Boehringer Ingelheim Investigational Site
City
Brampton
State/Province
Ontario
Country
Canada
Facility Name
1276.10.20007 Boehringer Ingelheim Investigational Site
City
Corunna
State/Province
Ontario
Country
Canada
Facility Name
1276.10.20006 Boehringer Ingelheim Investigational Site
City
Sarnia
State/Province
Ontario
Country
Canada
Facility Name
1276.10.20004 Boehringer Ingelheim Investigational Site
City
Drummondville
State/Province
Quebec
Country
Canada
Facility Name
1276.10.20003 Boehringer Ingelheim Investigational Site
City
Point Claire
State/Province
Quebec
Country
Canada
Facility Name
1276.10.20009 Boehringer Ingelheim Investigational Site
City
Victoriaville
State/Province
Quebec
Country
Canada
Facility Name
1276.10.37203 Boehringer Ingelheim Investigational Site
City
Pärnu
Country
Estonia
Facility Name
1276.10.37201 Boehringer Ingelheim Investigational Site
City
Tallinn
Country
Estonia
Facility Name
1276.10.37202 Boehringer Ingelheim Investigational Site
City
Tallinn
Country
Estonia
Facility Name
1276.10.37204 Boehringer Ingelheim Investigational Site
City
Viljandi County
Country
Estonia
Facility Name
1276.10.33002 Boehringer Ingelheim Investigational Site
City
Aire sur l'Adour
Country
France
Facility Name
1276.10.33003 Boehringer Ingelheim Investigational Site
City
Bischheim
Country
France
Facility Name
1276.10.33009 Boehringer Ingelheim Investigational Site
City
Bourg des Comptes
Country
France
Facility Name
1276.10.33014 Boehringer Ingelheim Investigational Site
City
Bourges
Country
France
Facility Name
1276.10.33007 Boehringer Ingelheim Investigational Site
City
Broglie
Country
France
Facility Name
1276.10.33001 Boehringer Ingelheim Investigational Site
City
Mont de Marsan
Country
France
Facility Name
1276.10.33008 Boehringer Ingelheim Investigational Site
City
Paris
Country
France
Facility Name
1276.10.33006 Boehringer Ingelheim Investigational Site
City
Saint Vinecnt de Tyrosse
Country
France
Facility Name
1276.10.33011 Boehringer Ingelheim Investigational Site
City
Segre
Country
France
Facility Name
1276.10.33004 Boehringer Ingelheim Investigational Site
City
Strasbourg
Country
France
Facility Name
1276.10.99501 Boehringer Ingelheim Investigational Site
City
Tbilisi
Country
Georgia
Facility Name
1276.10.99502 Boehringer Ingelheim Investigational Site
City
Tbilisi
Country
Georgia
Facility Name
1276.10.99503 Boehringer Ingelheim Investigational Site
City
Tbilisi
Country
Georgia
Facility Name
1276.10.99504 Boehringer Ingelheim Investigational Site
City
Tbilisi
Country
Georgia
Facility Name
1276.10.99505 Boehringer Ingelheim Investigational Site
City
Tbilisi
Country
Georgia
Facility Name
1276.10.99506 Boehringer Ingelheim Investigational Site
City
Tbilisi
Country
Georgia
Facility Name
1276.10.49001 Boehringer Ingelheim Investigational Site
City
Aschaffenburg
Country
Germany
Facility Name
1276.10.49006 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1276.10.49007 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1276.10.49005 Boehringer Ingelheim Investigational Site
City
Essen
Country
Germany
Facility Name
1276.10.49004 Boehringer Ingelheim Investigational Site
City
Frankfurt
Country
Germany
Facility Name
1276.10.49002 Boehringer Ingelheim Investigational Site
City
Nürnberg
Country
Germany
Facility Name
1276.10.49003 Boehringer Ingelheim Investigational Site
City
Rehlingen-Siersburg
Country
Germany
Facility Name
1276.10.50201 Boehringer Ingelheim Investigational Site
City
Guatemala Ciudad
Country
Guatemala
Facility Name
1276.10.50203 Boehringer Ingelheim Investigational Site
City
Guatemala Ciudad
Country
Guatemala
Facility Name
1276.10.50204 Boehringer Ingelheim Investigational Site
City
Guatemala Ciudad
Country
Guatemala
Facility Name
1276.10.50205 Boehringer Ingelheim Investigational Site
City
Guatemala Ciudad
Country
Guatemala
Facility Name
1276.10.50202 Boehringer Ingelheim Investigational Site
City
Quetzaltenango Ciudad
Country
Guatemala
Facility Name
1276.10.39004 Boehringer Ingelheim Investigational Site
City
Arenzano (GE)
Country
Italy
Facility Name
1276.10.39003 Boehringer Ingelheim Investigational Site
City
Bologna
Country
Italy
Facility Name
1276.10.39007 Boehringer Ingelheim Investigational Site
City
Catanzaro
Country
Italy
Facility Name
1276.10.39009 Boehringer Ingelheim Investigational Site
City
Catanzaro
Country
Italy
Facility Name
1276.10.39002 Boehringer Ingelheim Investigational Site
City
Napoli
Country
Italy
Facility Name
1276.10.39006 Boehringer Ingelheim Investigational Site
City
Palermo
Country
Italy
Facility Name
1276.10.39001 Boehringer Ingelheim Investigational Site
City
Roma
Country
Italy
Facility Name
1276.10.39008 Boehringer Ingelheim Investigational Site
City
Roma
Country
Italy
Facility Name
1276.10.39005 Boehringer Ingelheim Investigational Site
City
Torino
Country
Italy
Facility Name
1276.10.37102 Boehringer Ingelheim Investigational Site
City
Daugavpils
Country
Latvia
Facility Name
1276.10.37104 Boehringer Ingelheim Investigational Site
City
Ogre
Country
Latvia
Facility Name
1276.10.37101 Boehringer Ingelheim Investigational Site
City
Riga
Country
Latvia
Facility Name
1276.10.37103 Boehringer Ingelheim Investigational Site
City
Tukums
Country
Latvia
Facility Name
1276.10.37003 Boehringer Ingelheim Investigational Site
City
Kaunas
Country
Lithuania
Facility Name
1276.10.37004 Boehringer Ingelheim Investigational Site
City
Kaunas
Country
Lithuania
Facility Name
1276.10.37002 Boehringer Ingelheim Investigational Site
City
Klaipeda
Country
Lithuania
Facility Name
1276.10.37001 Boehringer Ingelheim Investigational Site
City
Vilnius
Country
Lithuania
Facility Name
1276.10.52001 Boehringer Ingelheim Investigational Site
City
Ciudad de Mexico
Country
Mexico
Facility Name
1276.10.52002 Boehringer Ingelheim Investigational Site
City
Ciudad de Mexico
Country
Mexico
Facility Name
1276.10.52003 Boehringer Ingelheim Investigational Site
City
Durango
Country
Mexico
Facility Name
1276.10.52005 Boehringer Ingelheim Investigational Site
City
Pachuca
Country
Mexico
Facility Name
1276.10.52004 Boehringer Ingelheim Investigational Site
City
Tijuana
Country
Mexico
Facility Name
1276.10.64001 Boehringer Ingelheim Investigational Site
City
Christchurch
Country
New Zealand
Facility Name
1276.10.64002 Boehringer Ingelheim Investigational Site
City
Greenlane East Auckland NZ
Country
New Zealand
Facility Name
1276.10.48001 Boehringer Ingelheim Investigational Site
City
Bialystok
Country
Poland
Facility Name
1276.10.48002 Boehringer Ingelheim Investigational Site
City
Bialystok
Country
Poland
Facility Name
1276.10.48008 Boehringer Ingelheim Investigational Site
City
Gizycko
Country
Poland
Facility Name
1276.10.48005 Boehringer Ingelheim Investigational Site
City
Katowice
Country
Poland
Facility Name
1276.10.48006 Boehringer Ingelheim Investigational Site
City
Katowice
Country
Poland
Facility Name
1276.10.48004 Boehringer Ingelheim Investigational Site
City
Krakow
Country
Poland
Facility Name
1276.10.48003 Boehringer Ingelheim Investigational Site
City
Warszawa
Country
Poland
Facility Name
1276.10.70001 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
1276.10.70002 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
1276.10.70003 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
1276.10.70004 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
1276.10.70005 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
1276.10.70007 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
1276.10.70008 Boehringer Ingelheim Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
1276.10.70009 Boehringer Ingelheim Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
1276.10.27004 Boehringer Ingelheim Investigational Site
City
Paarl
Country
South Africa
Facility Name
1276.10.27003 Boehringer Ingelheim Investigational Site
City
Parow
Country
South Africa
Facility Name
1276.10.27006 Boehringer Ingelheim Investigational Site
City
Plumstead, Cape Town
Country
South Africa
Facility Name
1276.10.27001 Boehringer Ingelheim Investigational Site
City
Pretoria
Country
South Africa
Facility Name
1276.10.27005 Boehringer Ingelheim Investigational Site
City
Pretoria
Country
South Africa
Facility Name
1276.10.27002 Boehringer Ingelheim Investigational Site
City
Somerset West
Country
South Africa
Facility Name
1276.10.34005 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1276.10.34001 Boehringer Ingelheim Investigational Site
City
L'Hospitalet de Llobregat
Country
Spain
Facility Name
1276.10.34003 Boehringer Ingelheim Investigational Site
City
L'Hospitalet de Llobregat
Country
Spain
Facility Name
1276.10.34002 Boehringer Ingelheim Investigational Site
City
Les Borges del Camp
Country
Spain
Facility Name
1276.10.34004 Boehringer Ingelheim Investigational Site
City
Sant Adria del Besos
Country
Spain
Facility Name
1276.10.34006 Boehringer Ingelheim Investigational Site
City
Vic
Country
Spain
Facility Name
1276.10.38002 Boehringer Ingelheim Investigational Site
City
Kharkiv
Country
Ukraine
Facility Name
1276.10.38007 Boehringer Ingelheim Investigational Site
City
Kharkiv
Country
Ukraine
Facility Name
1276.10.38001 Boehringer Ingelheim Investigational Site
City
Kiev
Country
Ukraine
Facility Name
1276.10.38004 Boehringer Ingelheim Investigational Site
City
Kiev
Country
Ukraine
Facility Name
1276.10.38005 Boehringer Ingelheim Investigational Site
City
Kyiv
Country
Ukraine

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
Links:
URL
http://trials.boehringer-ingelheim.com/
Description
Related Info

Learn more about this trial

A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy

We'll reach out to this number within 24 hrs