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Efficacy and Safety Study With Empagliflozin (BI 10773) vs. Placebo as add-on to Metformin or Metformin Plus Sulfonylurea Over 24 Weeks in Patients With Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo identical to BI 10773 high dose
Placebo identical to BI 10773 low dose
BI 10773
BI 10773
Placebo identical to BI 10773 low dose
BI 10773
Placebo identical to BI 10773 high dose
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

  2. Male and female patients on a diet and exercise regimen who are pre-treated with immediate release metformin or immediate release metformin plus sulfonylurea (see below for minimum doses). The treatment regimen has to be unchanged for 12 weeks prior to randomisation.

    Minimum dose for metformin: > or = 1500 mg/day or maximum tolerated dose or maximum dose according to local label Minimum dose for sulfonylurea: > or = half of the maximal recommended dose or maximum tolerated dose or maximum dose according to local label

  3. HbA1c of > or = 7.0% and < or = 11% at Visit 1 (screening) in order to be eligible for randomised treatment HbA1c of > 11% at Visit 1 (screening) in order to be eligible for the open-label treatment arm (25 mg BI 10773)
  4. Age> or = 18
  5. Body Mass Index (BM)I < or = 45 kg/m2 (Body Mass Index) at Visit 1 (Screening)
  6. Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion criteria:

  1. Uncontrolled hyperglycaemia with a glucose level > 240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day)
  2. Any other antidiabetic drug within 12 weeks prior to randomisation except those mentioned in inclusion criterion 2
  3. Myocardial infarction, stroke or transient ischemic attack (TIA) within 3 months prior to informed consent
  4. Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening and/or run-in phase
  5. Impaired renal function, defined as eGFR<30 ml/min (severe renal impairment) as determined during screening and/or run-in phase
  6. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
  7. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
  8. Contraindications to metformin and/or sulfonylurea according to the local label for those patients that enter the study with the respective background therapy
  9. Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anaemia)
  10. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight
  11. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except Typ 2 Diabetes

  12. Pre-menopausal women (last menstruation ¿ 1 year prior to informed consent) who:

    • are nursing or pregnant or
    • are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner
  13. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
  14. Participation in another trial with an investigational drug within 30 days prior to informed consent
  15. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial

Sites / Locations

  • 1245.23.10145 Boehringer Ingelheim Investigational Site
  • 1245.23.10046 Boehringer Ingelheim Investigational Site
  • 1245.23.10095 Boehringer Ingelheim Investigational Site
  • 1245.23.10109 Boehringer Ingelheim Investigational Site
  • 1245.23.10074 Boehringer Ingelheim Investigational Site
  • 1245.23.10149 Boehringer Ingelheim Investigational Site
  • 1245.23.10127 Boehringer Ingelheim Investigational Site
  • 1245.23.10042 Boehringer Ingelheim Investigational Site
  • 1245.23.10133 Boehringer Ingelheim Investigational Site
  • 1245.23.10080 Boehringer Ingelheim Investigational Site
  • 1245.23.10001 Boehringer Ingelheim Investigational Site
  • 1245.23.10159 Boehringer Ingelheim Investigational Site
  • 1245.23.10117 Boehringer Ingelheim Investigational Site
  • 1245.23.10157 Boehringer Ingelheim Investigational Site
  • 1245.23.10148 Boehringer Ingelheim Investigational Site
  • 1245.23.10034 Boehringer Ingelheim Investigational Site
  • 1245.23.10123 Boehringer Ingelheim Investigational Site
  • 1245.23.10120 Boehringer Ingelheim Investigational Site
  • 1245.23.10031 Boehringer Ingelheim Investigational Site
  • 1245.23.10158 Boehringer Ingelheim Investigational Site
  • 1245.23.10015 Boehringer Ingelheim Investigational Site
  • 1245.23.10156 Boehringer Ingelheim Investigational Site
  • 1245.23.10153 Boehringer Ingelheim Investigational Site
  • 1245.23.10143 Boehringer Ingelheim Investigational Site
  • 1245.23.10106 Boehringer Ingelheim Investigational Site
  • 1245.23.20032 Boehringer Ingelheim Investigational Site
  • 1245.23.20023 Boehringer Ingelheim Investigational Site
  • 1245.23.20028 Boehringer Ingelheim Investigational Site
  • 1245.23.20033 Boehringer Ingelheim Investigational Site
  • 1245.23.20024 Boehringer Ingelheim Investigational Site
  • 1245.23.20031 Boehringer Ingelheim Investigational Site
  • 1245.23.20026 Boehringer Ingelheim Investigational Site
  • 1245.23.20001 Boehringer Ingelheim Investigational Site
  • 1245.23.20022 Boehringer Ingelheim Investigational Site
  • 1245.23.20035 Boehringer Ingelheim Investigational Site
  • 1245.23.20030 Boehringer Ingelheim Investigational Site
  • 1245.23.20037 Boehringer Ingelheim Investigational Site
  • 1245.23.20029 Boehringer Ingelheim Investigational Site
  • 1245.23.20003 Boehringer Ingelheim Investigational Site
  • 1245.23.20040 Boehringer Ingelheim Investigational Site
  • 1245.23.20034 Boehringer Ingelheim Investigational Site
  • 1245.23.20039 Boehringer Ingelheim Investigational Site
  • 1245.23.20027 Boehringer Ingelheim Investigational Site
  • 1245.23.20025 Boehringer Ingelheim Investigational Site
  • 1245.23.20036 Boehringer Ingelheim Investigational Site
  • 1245.23.20038 Boehringer Ingelheim Investigational Site
  • 1245.23.86031 Boehringer Ingelheim Investigational Site
  • 1245.23.86032 Boehringer Ingelheim Investigational Site
  • 1245.23.86033 Boehringer Ingelheim Investigational Site
  • 1245.23.86034 Boehringer Ingelheim Investigational Site
  • 1245.23.86035 Boehringer Ingelheim Investigational Site
  • 1245.23.86048 Boehringer Ingelheim Investigational Site
  • 1245.23.86058 Boehringer Ingelheim Investigational Site
  • 1245.23.86038 Boehringer Ingelheim Investigational Site
  • 1245.23.86002 Boehringer Ingelheim Investigational Site
  • 1245.23.86052 Boehringer Ingelheim Investigational Site
  • 1245.23.86037 Boehringer Ingelheim Investigational Site
  • 1245.23.86049 Boehringer Ingelheim Investigational Site
  • 1245.23.86053 Boehringer Ingelheim Investigational Site
  • 1245.23.86055 Boehringer Ingelheim Investigational Site
  • 1245.23.86056 Boehringer Ingelheim Investigational Site
  • 1245.23.86042 Boehringer Ingelheim Investigational Site
  • 1245.23.86043 Boehringer Ingelheim Investigational Site
  • 1245.23.86039 Boehringer Ingelheim Investigational Site
  • 1245.23.86040 Boehringer Ingelheim Investigational Site
  • 1245.23.86054 Boehringer Ingelheim Investigational Site
  • 1245.23.86057 Boehringer Ingelheim Investigational Site
  • 1245.23.86045 Boehringer Ingelheim Investigational Site
  • 1245.23.86013 Boehringer Ingelheim Investigational Site
  • 1245.23.86036 Boehringer Ingelheim Investigational Site
  • 1245.23.86041 Boehringer Ingelheim Investigational Site
  • 1245.23.86051 Boehringer Ingelheim Investigational Site
  • 1245.23.33015 Boehringer Ingelheim Investigational Site
  • 1245.23.33008 Boehringer Ingelheim Investigational Site
  • 1245.23.33020 Boehringer Ingelheim Investigational Site
  • 1245.23.33002 Boehringer Ingelheim Investigational Site
  • 1245.23.33016 Boehringer Ingelheim Investigational Site
  • 1245.23.33001 Boehringer Ingelheim Investigational Site
  • 1245.23.33010 Boehringer Ingelheim Investigational Site
  • 1245.23.33009 Boehringer Ingelheim Investigational Site
  • 1245.23.33003 Boehringer Ingelheim Investigational Site
  • 1245.23.33045 Boehringer Ingelheim Investigational Site
  • 1245.23.33014 Boehringer Ingelheim Investigational Site
  • 1245.23.33004 Boehringer Ingelheim Investigational Site
  • 1245.23.33012 Boehringer Ingelheim Investigational Site
  • 1245.23.33013 Boehringer Ingelheim Investigational Site
  • 1245.23.33019 Boehringer Ingelheim Investigational Site
  • 1245.23.33007 Boehringer Ingelheim Investigational Site
  • 1245.23.33018 Boehringer Ingelheim Investigational Site
  • 1245.23.49001 Boehringer Ingelheim Investigational Site
  • 1245.23.49009 Boehringer Ingelheim Investigational Site
  • 1245.23.49004 Boehringer Ingelheim Investigational Site
  • 1245.23.49007 Boehringer Ingelheim Investigational Site
  • 1245.23.49002 Boehringer Ingelheim Investigational Site
  • 1245.23.49008 Boehringer Ingelheim Investigational Site
  • 1245.23.49010 Boehringer Ingelheim Investigational Site
  • 1245.23.49006 Boehringer Ingelheim Investigational Site
  • 1245.23.49011 Boehringer Ingelheim Investigational Site
  • 1245.23.49005 Boehringer Ingelheim Investigational Site
  • 1245.23.49003 Boehringer Ingelheim Investigational Site
  • 1245.23.91101 Boehringer Ingelheim Investigational Site
  • 1245.23.91104 Boehringer Ingelheim Investigational Site
  • 1245.23.91103 Boehringer Ingelheim Investigational Site
  • 1245.23.91102 Boehringer Ingelheim Investigational Site
  • 1245.23.91105 Boehringer Ingelheim Investigational Site
  • 1245.23.82012 Boehringer Ingelheim Investigational Site
  • 1245.23.82004 Boehringer Ingelheim Investigational Site
  • 1245.23.82011 Boehringer Ingelheim Investigational Site
  • 1245.23.82009 Boehringer Ingelheim Investigational Site
  • 1245.23.82001 Boehringer Ingelheim Investigational Site
  • 1245.23.82006 Boehringer Ingelheim Investigational Site
  • 1245.23.82005 Boehringer Ingelheim Investigational Site
  • 1245.23.82007 Boehringer Ingelheim Investigational Site
  • 1245.23.82008 Boehringer Ingelheim Investigational Site
  • 1245.23.82010 Boehringer Ingelheim Investigational Site
  • 1245.23.82014 Boehringer Ingelheim Investigational Site
  • 1245.23.82002 Boehringer Ingelheim Investigational Site
  • 1245.23.82003 Boehringer Ingelheim Investigational Site
  • 1245.23.52003 Boehringer Ingelheim Investigational Site
  • 1245.23.52004 Boehringer Ingelheim Investigational Site
  • 1245.23.52001 Boehringer Ingelheim Investigational Site
  • 1245.23.52002 Boehringer Ingelheim Investigational Site
  • 1245.23.74005 Boehringer Ingelheim Investigational Site
  • 1245.23.74002 Boehringer Ingelheim Investigational Site
  • 1245.23.74006 Boehringer Ingelheim Investigational Site
  • 1245.23.74014 Boehringer Ingelheim Investigational Site
  • 1245.23.74001 Boehringer Ingelheim Investigational Site
  • 1245.23.74004 Boehringer Ingelheim Investigational Site
  • 1245.23.74003 Boehringer Ingelheim Investigational Site
  • 1245.23.38003 Boehringer Ingelheim Investigational Site
  • 1245.23.38002 Boehringer Ingelheim Investigational Site
  • 1245.23.38001 Boehringer Ingelheim Investigational Site
  • 1245.23.88010 Boehringer Ingelheim Investigational Site
  • 1245.23.88011 Boehringer Ingelheim Investigational Site
  • 1245.23.88012 Boehringer Ingelheim Investigational Site
  • 1245.23.88013 Boehringer Ingelheim Investigational Site
  • 1245.23.88009 Boehringer Ingelheim Investigational Site
  • 1245.23.88014 Boehringer Ingelheim Investigational Site
  • 1245.23.88006 Boehringer Ingelheim Investigational Site
  • 1245.23.88007 Boehringer Ingelheim Investigational Site
  • 1245.23.88021 Boehringer Ingelheim Investigational Site
  • 1245.23.88008 Boehringer Ingelheim Investigational Site
  • 1245.23.90003 Boehringer Ingelheim Investigational Site
  • 1245.23.90001 Boehringer Ingelheim Investigational Site
  • 1245.23.90002 Boehringer Ingelheim Investigational Site
  • 1245.23.90006 Boehringer Ingelheim Investigational Site
  • 1245.23.90007 Boehringer Ingelheim Investigational Site
  • 1245.23.90004 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

BI 10773 Arm 2

Placebo

BI 10773 open-label

BI 10773 Arm 1

Arm Description

BI 10773 once daily high dose

Placebo matching BI 10773

BI 10773 once daily high dose open label

BI 10773 once daily low dose

Outcomes

Primary Outcome Measures

HbA1c Change From Baseline
Change from baseline in HbA1c after 24 weeks. For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication.

Secondary Outcome Measures

Body Weight Change From Baseline
Body weight change from baseline after 24 weeks. For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication.
Mean Daily Plasma Glucose (MDG) Change From Baseline
Change from baseline in mean daily glucose (MDG) using the 8-point blood glucose profile, after 24 weeks of treatment. For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication.

Full Information

First Posted
July 8, 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
NCT01159600
Brief Title
Efficacy and Safety Study With Empagliflozin (BI 10773) vs. Placebo as add-on to Metformin or Metformin Plus Sulfonylurea Over 24 Weeks in Patients With Type 2 Diabetes
Official Title
A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg, 25 mg) Administered Orally, Once Daily Over 24 Weeks in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite Treatment With Metformin Alone or Metformin in Combination With a Sulfonylurea
Study Type
Interventional

2. Study Status

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

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 objective of the current study is to investigate the efficacy, safety and tolerability of two doses of BI 10773 compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with Typ 2 Diabetes Mellitus with insufficient glycaemic control.

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 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1504 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BI 10773 Arm 2
Arm Type
Experimental
Arm Description
BI 10773 once daily high dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo matching BI 10773
Arm Title
BI 10773 open-label
Arm Type
Experimental
Arm Description
BI 10773 once daily high dose open label
Arm Title
BI 10773 Arm 1
Arm Type
Experimental
Arm Description
BI 10773 once daily low dose
Intervention Type
Drug
Intervention Name(s)
Placebo identical to BI 10773 high dose
Intervention Description
Placebo tablets matching BI 10773 high dose
Intervention Type
Drug
Intervention Name(s)
Placebo identical to BI 10773 low dose
Intervention Description
Placebo tablets matching BI 10773 low dose
Intervention Type
Drug
Intervention Name(s)
BI 10773
Intervention Description
BI 10773 tablets once daily high dose open label
Intervention Type
Drug
Intervention Name(s)
BI 10773
Intervention Description
BI 10773 tablets once daily high dose
Intervention Type
Drug
Intervention Name(s)
Placebo identical to BI 10773 low dose
Intervention Description
Placebo tablets matching BI 10773 low dose
Intervention Type
Drug
Intervention Name(s)
BI 10773
Intervention Description
BI 10773 tablets once daily low dose
Intervention Type
Drug
Intervention Name(s)
Placebo identical to BI 10773 high dose
Intervention Description
Placebo tablets matching BI 10773 high dose
Primary Outcome Measure Information:
Title
HbA1c Change From Baseline
Description
Change from baseline in HbA1c after 24 weeks. For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication.
Time Frame
Baseline and 24 weeks
Secondary Outcome Measure Information:
Title
Body Weight Change From Baseline
Description
Body weight change from baseline after 24 weeks. For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication.
Time Frame
Baseline and 24 weeks
Title
Mean Daily Plasma Glucose (MDG) Change From Baseline
Description
Change from baseline in mean daily glucose (MDG) using the 8-point blood glucose profile, after 24 weeks of treatment. For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication.
Time Frame
Baseline and 24 weeks
Other Pre-specified Outcome Measures:
Title
Confirmed Hypoglycaemic Adverse Events
Description
Number of patients with confirmed hypoglycaemic events, as reported as adverse events.
Time Frame
From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 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 Male and female patients on a diet and exercise regimen who are pre-treated with immediate release metformin or immediate release metformin plus sulfonylurea (see below for minimum doses). The treatment regimen has to be unchanged for 12 weeks prior to randomisation. Minimum dose for metformin: > or = 1500 mg/day or maximum tolerated dose or maximum dose according to local label Minimum dose for sulfonylurea: > or = half of the maximal recommended dose or maximum tolerated dose or maximum dose according to local label HbA1c of > or = 7.0% and < or = 11% at Visit 1 (screening) in order to be eligible for randomised treatment HbA1c of > 11% at Visit 1 (screening) in order to be eligible for the open-label treatment arm (25 mg BI 10773) Age> or = 18 Body Mass Index (BM)I < or = 45 kg/m2 (Body Mass Index) at Visit 1 (Screening) Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation Exclusion criteria: Uncontrolled hyperglycaemia with a glucose level > 240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day) Any other antidiabetic drug within 12 weeks prior to randomisation except those mentioned in inclusion criterion 2 Myocardial infarction, stroke or transient ischemic attack (TIA) within 3 months prior to informed consent Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening and/or run-in phase Impaired renal function, defined as eGFR<30 ml/min (severe renal impairment) as determined during screening and/or run-in phase Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years Contraindications to metformin and/or sulfonylurea according to the local label for those patients that enter the study with the respective background therapy Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anaemia) Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except Typ 2 Diabetes Pre-menopausal women (last menstruation ¿ 1 year prior to informed consent) who: are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake Participation in another trial with an investigational drug within 30 days prior to informed consent Any other clinical condition that would jeopardize patients safety while participating in this clinical trial
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
1245.23.10145 Boehringer Ingelheim Investigational Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
1245.23.10046 Boehringer Ingelheim Investigational Site
City
Tempe
State/Province
Arizona
Country
United States
Facility Name
1245.23.10095 Boehringer Ingelheim Investigational Site
City
Huntington Park
State/Province
California
Country
United States
Facility Name
1245.23.10109 Boehringer Ingelheim Investigational Site
City
Huntington Park
State/Province
California
Country
United States
Facility Name
1245.23.10074 Boehringer Ingelheim Investigational Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
1245.23.10149 Boehringer Ingelheim Investigational Site
City
Rancho Cucamonga
State/Province
California
Country
United States
Facility Name
1245.23.10127 Boehringer Ingelheim Investigational Site
City
Waterbury
State/Province
Connecticut
Country
United States
Facility Name
1245.23.10042 Boehringer Ingelheim Investigational Site
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
1245.23.10133 Boehringer Ingelheim Investigational Site
City
Jupiter
State/Province
Florida
Country
United States
Facility Name
1245.23.10080 Boehringer Ingelheim Investigational Site
City
Decatur
State/Province
Georgia
Country
United States
Facility Name
1245.23.10001 Boehringer Ingelheim Investigational Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
1245.23.10159 Boehringer Ingelheim Investigational Site
City
Des Moines
State/Province
Iowa
Country
United States
Facility Name
1245.23.10117 Boehringer Ingelheim Investigational Site
City
Arkansas City
State/Province
Kansas
Country
United States
Facility Name
1245.23.10157 Boehringer Ingelheim Investigational Site
City
Newton
State/Province
Kansas
Country
United States
Facility Name
1245.23.10148 Boehringer Ingelheim Investigational Site
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
1245.23.10034 Boehringer Ingelheim Investigational Site
City
Rochester
State/Province
New York
Country
United States
Facility Name
1245.23.10123 Boehringer Ingelheim Investigational Site
City
Smithtown
State/Province
New York
Country
United States
Facility Name
1245.23.10120 Boehringer Ingelheim Investigational Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
1245.23.10031 Boehringer Ingelheim Investigational Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
1245.23.10158 Boehringer Ingelheim Investigational Site
City
Mount Pleasant
State/Province
South Carolina
Country
United States
Facility Name
1245.23.10015 Boehringer Ingelheim Investigational Site
City
Simpsonville
State/Province
South Carolina
Country
United States
Facility Name
1245.23.10156 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1245.23.10153 Boehringer Ingelheim Investigational Site
City
Hurst
State/Province
Texas
Country
United States
Facility Name
1245.23.10143 Boehringer Ingelheim Investigational Site
City
Killeen
State/Province
Texas
Country
United States
Facility Name
1245.23.10106 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
1245.23.20032 Boehringer Ingelheim Investigational Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
1245.23.20023 Boehringer Ingelheim Investigational Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
1245.23.20028 Boehringer Ingelheim Investigational Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
1245.23.20033 Boehringer Ingelheim Investigational Site
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
1245.23.20024 Boehringer Ingelheim Investigational Site
City
Paradise
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
1245.23.20031 Boehringer Ingelheim Investigational Site
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
1245.23.20026 Boehringer Ingelheim Investigational Site
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
1245.23.20001 Boehringer Ingelheim Investigational Site
City
Barrie
State/Province
Ontario
Country
Canada
Facility Name
1245.23.20022 Boehringer Ingelheim Investigational Site
City
Brampton
State/Province
Ontario
Country
Canada
Facility Name
1245.23.20035 Boehringer Ingelheim Investigational Site
City
Corunna
State/Province
Ontario
Country
Canada
Facility Name
1245.23.20030 Boehringer Ingelheim Investigational Site
City
Etobicoke
State/Province
Ontario
Country
Canada
Facility Name
1245.23.20037 Boehringer Ingelheim Investigational Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
1245.23.20029 Boehringer Ingelheim Investigational Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
1245.23.20003 Boehringer Ingelheim Investigational Site
City
Markham
State/Province
Ontario
Country
Canada
Facility Name
1245.23.20040 Boehringer Ingelheim Investigational Site
City
Oakville
State/Province
Ontario
Country
Canada
Facility Name
1245.23.20034 Boehringer Ingelheim Investigational Site
City
Sarnia
State/Province
Ontario
Country
Canada
Facility Name
1245.23.20039 Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1245.23.20027 Boehringer Ingelheim Investigational Site
City
Laval
State/Province
Quebec
Country
Canada
Facility Name
1245.23.20025 Boehringer Ingelheim Investigational Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
1245.23.20036 Boehringer Ingelheim Investigational Site
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
1245.23.20038 Boehringer Ingelheim Investigational Site
City
Ville Saint-Laurent
State/Province
Quebec
Country
Canada
Facility Name
1245.23.86031 Boehringer Ingelheim Investigational Site
City
Beijing
Country
China
Facility Name
1245.23.86032 Boehringer Ingelheim Investigational Site
City
Beijing
Country
China
Facility Name
1245.23.86033 Boehringer Ingelheim Investigational Site
City
Beijing
Country
China
Facility Name
1245.23.86034 Boehringer Ingelheim Investigational Site
City
Beijing
Country
China
Facility Name
1245.23.86035 Boehringer Ingelheim Investigational Site
City
Beijing
Country
China
Facility Name
1245.23.86048 Boehringer Ingelheim Investigational Site
City
Chengdu
Country
China
Facility Name
1245.23.86058 Boehringer Ingelheim Investigational Site
City
Chongqing
Country
China
Facility Name
1245.23.86038 Boehringer Ingelheim Investigational Site
City
Dalian
Country
China
Facility Name
1245.23.86002 Boehringer Ingelheim Investigational Site
City
Guangzhou
Country
China
Facility Name
1245.23.86052 Boehringer Ingelheim Investigational Site
City
Guangzhou
Country
China
Facility Name
1245.23.86037 Boehringer Ingelheim Investigational Site
City
Haerbin
Country
China
Facility Name
1245.23.86049 Boehringer Ingelheim Investigational Site
City
Jinan
Country
China
Facility Name
1245.23.86053 Boehringer Ingelheim Investigational Site
City
Jinan
Country
China
Facility Name
1245.23.86055 Boehringer Ingelheim Investigational Site
City
Nan Ning
Country
China
Facility Name
1245.23.86056 Boehringer Ingelheim Investigational Site
City
Nan Ning
Country
China
Facility Name
1245.23.86042 Boehringer Ingelheim Investigational Site
City
Nanjing
Country
China
Facility Name
1245.23.86043 Boehringer Ingelheim Investigational Site
City
Nanjing
Country
China
Facility Name
1245.23.86039 Boehringer Ingelheim Investigational Site
City
Shanghai
Country
China
Facility Name
1245.23.86040 Boehringer Ingelheim Investigational Site
City
Shanghai
Country
China
Facility Name
1245.23.86054 Boehringer Ingelheim Investigational Site
City
Shantou
Country
China
Facility Name
1245.23.86057 Boehringer Ingelheim Investigational Site
City
Shenyang
Country
China
Facility Name
1245.23.86045 Boehringer Ingelheim Investigational Site
City
Shijiazhuang
Country
China
Facility Name
1245.23.86013 Boehringer Ingelheim Investigational Site
City
Suzhou
Country
China
Facility Name
1245.23.86036 Boehringer Ingelheim Investigational Site
City
Tianjin
Country
China
Facility Name
1245.23.86041 Boehringer Ingelheim Investigational Site
City
Xi'An
Country
China
Facility Name
1245.23.86051 Boehringer Ingelheim Investigational Site
City
Zhenjiang
Country
China
Facility Name
1245.23.33015 Boehringer Ingelheim Investigational Site
City
Arras
Country
France
Facility Name
1245.23.33008 Boehringer Ingelheim Investigational Site
City
Bersée
Country
France
Facility Name
1245.23.33020 Boehringer Ingelheim Investigational Site
City
Bischheim
Country
France
Facility Name
1245.23.33002 Boehringer Ingelheim Investigational Site
City
Bondy Cedex
Country
France
Facility Name
1245.23.33016 Boehringer Ingelheim Investigational Site
City
Bruay La Buissiere
Country
France
Facility Name
1245.23.33001 Boehringer Ingelheim Investigational Site
City
Corbeil Essonnes
Country
France
Facility Name
1245.23.33010 Boehringer Ingelheim Investigational Site
City
Croix
Country
France
Facility Name
1245.23.33009 Boehringer Ingelheim Investigational Site
City
Hautmont
Country
France
Facility Name
1245.23.33003 Boehringer Ingelheim Investigational Site
City
La Rochelle Cedex 1
Country
France
Facility Name
1245.23.33045 Boehringer Ingelheim Investigational Site
City
Marseille
Country
France
Facility Name
1245.23.33014 Boehringer Ingelheim Investigational Site
City
Mundolsheim
Country
France
Facility Name
1245.23.33004 Boehringer Ingelheim Investigational Site
City
Narbonne Cedex
Country
France
Facility Name
1245.23.33012 Boehringer Ingelheim Investigational Site
City
Schiltigheim
Country
France
Facility Name
1245.23.33013 Boehringer Ingelheim Investigational Site
City
Strasbourg
Country
France
Facility Name
1245.23.33019 Boehringer Ingelheim Investigational Site
City
Strasbourg
Country
France
Facility Name
1245.23.33007 Boehringer Ingelheim Investigational Site
City
Vieux Condé
Country
France
Facility Name
1245.23.33018 Boehringer Ingelheim Investigational Site
City
Wattrelos
Country
France
Facility Name
1245.23.49001 Boehringer Ingelheim Investigational Site
City
Dormagen
Country
Germany
Facility Name
1245.23.49009 Boehringer Ingelheim Investigational Site
City
Flörsheim
Country
Germany
Facility Name
1245.23.49004 Boehringer Ingelheim Investigational Site
City
Hatten
Country
Germany
Facility Name
1245.23.49007 Boehringer Ingelheim Investigational Site
City
Künzing
Country
Germany
Facility Name
1245.23.49002 Boehringer Ingelheim Investigational Site
City
Neuwied
Country
Germany
Facility Name
1245.23.49008 Boehringer Ingelheim Investigational Site
City
Nürnberg
Country
Germany
Facility Name
1245.23.49010 Boehringer Ingelheim Investigational Site
City
Rednitzhembach
Country
Germany
Facility Name
1245.23.49006 Boehringer Ingelheim Investigational Site
City
Rehburg-Loccum
Country
Germany
Facility Name
1245.23.49011 Boehringer Ingelheim Investigational Site
City
Rehlingen-Siersburg
Country
Germany
Facility Name
1245.23.49005 Boehringer Ingelheim Investigational Site
City
Saarbrücken
Country
Germany
Facility Name
1245.23.49003 Boehringer Ingelheim Investigational Site
City
Unterschneidheim
Country
Germany
Facility Name
1245.23.91101 Boehringer Ingelheim Investigational Site
City
Coimbatore
Country
India
Facility Name
1245.23.91104 Boehringer Ingelheim Investigational Site
City
Indore
Country
India
Facility Name
1245.23.91103 Boehringer Ingelheim Investigational Site
City
Maharashtra
Country
India
Facility Name
1245.23.91102 Boehringer Ingelheim Investigational Site
City
Nagpur
Country
India
Facility Name
1245.23.91105 Boehringer Ingelheim Investigational Site
City
Pune
Country
India
Facility Name
1245.23.82012 Boehringer Ingelheim Investigational Site
City
Anyang
Country
Korea, Republic of
Facility Name
1245.23.82004 Boehringer Ingelheim Investigational Site
City
Busan
Country
Korea, Republic of
Facility Name
1245.23.82011 Boehringer Ingelheim Investigational Site
City
Goyang
Country
Korea, Republic of
Facility Name
1245.23.82009 Boehringer Ingelheim Investigational Site
City
Ilsan
Country
Korea, Republic of
Facility Name
1245.23.82001 Boehringer Ingelheim Investigational Site
City
Incheon
Country
Korea, Republic of
Facility Name
1245.23.82006 Boehringer Ingelheim Investigational Site
City
Jeonju
Country
Korea, Republic of
Facility Name
1245.23.82005 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1245.23.82007 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1245.23.82008 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1245.23.82010 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1245.23.82014 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1245.23.82002 Boehringer Ingelheim Investigational Site
City
Suwon
Country
Korea, Republic of
Facility Name
1245.23.82003 Boehringer Ingelheim Investigational Site
City
Wonju
Country
Korea, Republic of
Facility Name
1245.23.52003 Boehringer Ingelheim Investigational Site
City
Guadalajara
Country
Mexico
Facility Name
1245.23.52004 Boehringer Ingelheim Investigational Site
City
Guadalajara
Country
Mexico
Facility Name
1245.23.52001 Boehringer Ingelheim Investigational Site
City
Monterrey
Country
Mexico
Facility Name
1245.23.52002 Boehringer Ingelheim Investigational Site
City
Monterrey
Country
Mexico
Facility Name
1245.23.74005 Boehringer Ingelheim Investigational Site
City
Bratislava
Country
Slovakia
Facility Name
1245.23.74002 Boehringer Ingelheim Investigational Site
City
Lucenec
Country
Slovakia
Facility Name
1245.23.74006 Boehringer Ingelheim Investigational Site
City
Nitra
Country
Slovakia
Facility Name
1245.23.74014 Boehringer Ingelheim Investigational Site
City
Nove Zamky
Country
Slovakia
Facility Name
1245.23.74001 Boehringer Ingelheim Investigational Site
City
Povazska Bystrica
Country
Slovakia
Facility Name
1245.23.74004 Boehringer Ingelheim Investigational Site
City
Presov
Country
Slovakia
Facility Name
1245.23.74003 Boehringer Ingelheim Investigational Site
City
Trebisov
Country
Slovakia
Facility Name
1245.23.38003 Boehringer Ingelheim Investigational Site
City
Celje
Country
Slovenia
Facility Name
1245.23.38002 Boehringer Ingelheim Investigational Site
City
Koper
Country
Slovenia
Facility Name
1245.23.38001 Boehringer Ingelheim Investigational Site
City
Maribor
Country
Slovenia
Facility Name
1245.23.88010 Boehringer Ingelheim Investigational Site
City
Kaohsiung
Country
Taiwan
Facility Name
1245.23.88011 Boehringer Ingelheim Investigational Site
City
Kaohsiung
Country
Taiwan
Facility Name
1245.23.88012 Boehringer Ingelheim Investigational Site
City
Kaohsiung
Country
Taiwan
Facility Name
1245.23.88013 Boehringer Ingelheim Investigational Site
City
Kaohsiung
Country
Taiwan
Facility Name
1245.23.88009 Boehringer Ingelheim Investigational Site
City
Taichung
Country
Taiwan
Facility Name
1245.23.88014 Boehringer Ingelheim Investigational Site
City
Tainan
Country
Taiwan
Facility Name
1245.23.88006 Boehringer Ingelheim Investigational Site
City
Taipei
Country
Taiwan
Facility Name
1245.23.88007 Boehringer Ingelheim Investigational Site
City
Taipei
Country
Taiwan
Facility Name
1245.23.88021 Boehringer Ingelheim Investigational Site
City
Taipei
Country
Taiwan
Facility Name
1245.23.88008 Boehringer Ingelheim Investigational Site
City
Taoyuan County
Country
Taiwan
Facility Name
1245.23.90003 Boehringer Ingelheim Investigational Site
City
Erzurum
Country
Turkey
Facility Name
1245.23.90001 Boehringer Ingelheim Investigational Site
City
Gaziantep
Country
Turkey
Facility Name
1245.23.90002 Boehringer Ingelheim Investigational Site
City
Istanbul
Country
Turkey
Facility Name
1245.23.90006 Boehringer Ingelheim Investigational Site
City
Istanbul
Country
Turkey
Facility Name
1245.23.90007 Boehringer Ingelheim Investigational Site
City
Istanbul
Country
Turkey
Facility Name
1245.23.90004 Boehringer Ingelheim Investigational Site
City
Izmir
Country
Turkey

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
33084149
Citation
Inzucchi SE, Davies MJ, Khunti K, Trivedi P, George JT, Zwiener I, Johansen OE, Sattar N. Empagliflozin treatment effects across categories of baseline HbA1c, body weight and blood pressure as an add-on to metformin in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Feb;23(2):425-433. doi: 10.1111/dom.14234. Epub 2020 Nov 20.
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
23963895
Citation
Haring HU, Merker L, Seewaldt-Becker E, Weimer M, Meinicke T, Woerle HJ, Broedl UC; EMPA-REG METSU Trial Investigators. Empagliflozin as add-on to metformin plus sulfonylurea in patients with type 2 diabetes: a 24-week, randomized, double-blind, placebo-controlled trial. Diabetes Care. 2013 Nov;36(11):3396-404. doi: 10.2337/dc12-2673. Epub 2013 Aug 20.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1245/1245.23_U12-1518-01.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1245/1245.23_Literature.pdf
Description
Related Info

Learn more about this trial

Efficacy and Safety Study With Empagliflozin (BI 10773) vs. Placebo as add-on to Metformin or Metformin Plus Sulfonylurea Over 24 Weeks in Patients With Type 2 Diabetes

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