search
Back to results

Efficacy and Safety of Empagliflozin (BI 10773) Versus Placebo and Sitagliptin 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 BI10773 high dose
BI 10773
BI 10773 open label
Placebo identical to BI10773 low dose
Placebo identical to BI10773 low dose
Placebo identical to BI10773 high dose
Placebo identical to Sitagliptin 100mg
Placebo identical to Sitagliptin 100mg
BI10773
Sitagliptin
Placebo identical to Sitagliptin 100mg
Placebo identical to BI10773 low dose
Placebo identical to BI10773 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 diet and exercise regimen who are drug-naïve;
  3. HbA1c >= 7.0% and <= 10.0% at Visit 1 (screening) for randomised treatment; HbA1c > 10.0% at visit 1 (screening) for the open-label BI 10773 arm;
  4. Age >= 20 (Japan); Age >= 18 (countries other than Japan);
  5. BMI <= 45 kg/m2 at Visit 1 (screening);
  6. Signed and dated written informed consent by date of Visit 1

Exclusion criteria:

  1. Uncontrolled hyperglycaemia;
  2. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent;
  3. Indication of liver disease, either ALT, AST, or alkaline phosphatase above 3 x ULN;
  4. Impaired renal function (eGFR<50 ml/min);
  5. Bariatric surgery within the past two years or other GI surgeries;
  6. Medical history of cancer;
  7. Contraindications to sitagliptin;
  8. Blood dyscrasias or any disorders causing haemolysis or unstable red blood cell;
  9. Treatment with any anti-diabetes drug within 12 weeks prior to randomisation;
  10. Treatment with anti-obesity drugs or any other treatment leading to unstable body weight;
  11. Current treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM;
  12. Pre-menopausal women who are nursing or pregnant or are of child-bearing potential and not practicing an acceptable method of birth control;
  13. Alcohol or drug abuse;
  14. Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial;
  15. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial

Sites / Locations

  • 1245.20.10124 Boehringer Ingelheim Investigational Site
  • 1245.20.10108 Boehringer Ingelheim Investigational Site
  • 1245.20.10150 Boehringer Ingelheim Investigational Site
  • 1245.20.10154 Boehringer Ingelheim Investigational Site
  • 1245.20.10009 Boehringer Ingelheim Investigational Site
  • 1245.20.10131 Boehringer Ingelheim Investigational Site
  • 1245.20.10038 Boehringer Ingelheim Investigational Site
  • 1245.20.10137 Boehringer Ingelheim Investigational Site
  • 1245.20.10006 Boehringer Ingelheim Investigational Site
  • 1245.20.10085 Boehringer Ingelheim Investigational Site
  • 1245.20.10078 Boehringer Ingelheim Investigational Site
  • 1245.20.10080 Boehringer Ingelheim Investigational Site
  • 1245.20.10128 Boehringer Ingelheim Investigational Site
  • 1245.20.10060 Boehringer Ingelheim Investigational Site
  • 1245.20.10065 Boehringer Ingelheim Investigational Site
  • 1245.20.10117 Boehringer Ingelheim Investigational Site
  • 1245.20.10039 Boehringer Ingelheim Investigational Site
  • 1245.20.10146 Boehringer Ingelheim Investigational Site
  • 1245.20.10144 Boehringer Ingelheim Investigational Site
  • 1245.20.10115 Boehringer Ingelheim Investigational Site
  • 1245.20.10129 Boehringer Ingelheim Investigational Site
  • 1245.20.10045 Boehringer Ingelheim Investigational Site
  • 1245.20.10119 Boehringer Ingelheim Investigational Site
  • 1245.20.10130 Boehringer Ingelheim Investigational Site
  • 1245.20.10089 Boehringer Ingelheim Investigational Site
  • 1245.20.10151 Boehringer Ingelheim Investigational Site
  • 1245.20.10155 Boehringer Ingelheim Investigational Site
  • 1245.20.32008 Boehringer Ingelheim Investigational Site
  • 1245.20.32011 Boehringer Ingelheim Investigational Site
  • 1245.20.32023 Boehringer Ingelheim Investigational Site
  • 1245.20.32003 Boehringer Ingelheim Investigational Site
  • 1245.20.32015 Boehringer Ingelheim Investigational Site
  • 1245.20.32016 Boehringer Ingelheim Investigational Site
  • 1245.20.32025 Boehringer Ingelheim Investigational Site
  • 1245.20.32022 Boehringer Ingelheim Investigational Site
  • 1245.20.32019 Boehringer Ingelheim Investigational Site
  • 1245.20.32024 Boehringer Ingelheim Investigational Site
  • 1245.20.32021 Boehringer Ingelheim Investigational Site
  • 1245.20.32027 Boehringer Ingelheim Investigational Site
  • 1245.20.32020 Boehringer Ingelheim Investigational Site
  • 1245.20.32018 Boehringer Ingelheim Investigational Site
  • 1245.20.32026 Boehringer Ingelheim Investigational Site
  • 1245.20.20011 Boehringer Ingelheim Investigational Site
  • 1245.20.20018 Boehringer Ingelheim Investigational Site
  • 1245.20.20015 Boehringer Ingelheim Investigational Site
  • 1245.20.20012 Boehringer Ingelheim Investigational Site
  • 1245.20.20016 Boehringer Ingelheim Investigational Site
  • 1245.20.20008 Boehringer Ingelheim Investigational Site
  • 1245.20.20001 Boehringer Ingelheim Investigational Site
  • 1245.20.20019 Boehringer Ingelheim Investigational Site
  • 1245.20.20010 Boehringer Ingelheim Investigational Site
  • 1245.20.20017 Boehringer Ingelheim Investigational Site
  • 1245.20.20003 Boehringer Ingelheim Investigational Site
  • 1245.20.20009 Boehringer Ingelheim Investigational Site
  • 1245.20.20013 Boehringer Ingelheim Investigational Site
  • 1245.20.20005 Boehringer Ingelheim Investigational Site
  • 1245.20.20002 Boehringer Ingelheim Investigational Site
  • 1245.20.20006 Boehringer Ingelheim Investigational Site
  • 1245.20.20014 Boehringer Ingelheim Investigational Site
  • 1245.20.20007 Boehringer Ingelheim Investigational Site
  • 1245.20.20021 Boehringer Ingelheim Investigational Site
  • 1245.20.86007 Boehringer Ingelheim Investigational Site
  • 1245.20.86008 Boehringer Ingelheim Investigational Site
  • 1245.20.86001 Boehringer Ingelheim Investigational Site
  • 1245.20.86002 Boehringer Ingelheim Investigational Site
  • 1245.20.86003 Boehringer Ingelheim Investigational Site
  • 1245.20.86012 Boehringer Ingelheim Investigational Site
  • 1245.20.86020 Boehringer Ingelheim Investigational Site
  • 1245.20.86049 Boehringer Ingelheim Investigational Site
  • 1245.20.86018 Boehringer Ingelheim Investigational Site
  • 1245.20.86019 Boehringer Ingelheim Investigational Site
  • 1245.20.86010 Boehringer Ingelheim Investigational Site
  • 1245.20.86043 Boehringer Ingelheim Investigational Site
  • 1245.20.86016 Boehringer Ingelheim Investigational Site
  • 1245.20.86004 Boehringer Ingelheim Investigational Site
  • 1245.20.86005 Boehringer Ingelheim Investigational Site
  • 1245.20.86006 Boehringer Ingelheim Investigational Site
  • 1245.20.86057 Boehringer Ingelheim Investigational Site
  • 1245.20.86017 Boehringer Ingelheim Investigational Site
  • 1245.20.86013 Boehringer Ingelheim Investigational Site
  • 1245.20.86015 Boehringer Ingelheim Investigational Site
  • 1245.20.86009 Boehringer Ingelheim Investigational Site
  • 1245.20.86011 Boehringer Ingelheim Investigational Site
  • 1245.20.86014 Boehringer Ingelheim Investigational Site
  • 1245.20.49013 Boehringer Ingelheim Investigational Site
  • 1245.20.49016 Boehringer Ingelheim Investigational Site
  • 1245.20.49015 Boehringer Ingelheim Investigational Site
  • 1245.20.49019 Boehringer Ingelheim Investigational Site
  • 1245.20.49020 Boehringer Ingelheim Investigational Site
  • 1245.20.49014 Boehringer Ingelheim Investigational Site
  • 1245.20.49002 Boehringer Ingelheim Investigational Site
  • 1245.20.49008 Boehringer Ingelheim Investigational Site
  • 1245.20.49022 Boehringer Ingelheim Investigational Site
  • 1245.20.49017 Boehringer Ingelheim Investigational Site
  • 1245.20.49003 Boehringer Ingelheim Investigational Site
  • 1245.20.91005 Boehringer Ingelheim Investigational Site
  • 1245.20.91006 Boehringer Ingelheim Investigational Site
  • 1245.20.91008 Boehringer Ingelheim Investigational Site
  • 1245.20.91003 Boehringer Ingelheim Investigational Site
  • 1245.20.91004 Boehringer Ingelheim Investigational Site
  • 1245.20.91009 Boehringer Ingelheim Investigational Site
  • 1245.20.91007 Boehringer Ingelheim Investigational Site
  • 1245.20.91002 Boehringer Ingelheim Investigational Site
  • 1245.20.91010 Boehringer Ingelheim Investigational Site
  • 1245.20.91001 Boehringer Ingelheim Investigational Site
  • 1245.20.35302 Boehringer Ingelheim Investigational Site
  • 1245.20.35305 Boehringer Ingelheim Investigational Site
  • 1245.20.35303 Boehringer Ingelheim Investigational Site
  • 1245.20.35304 Boehringer Ingelheim Investigational Site
  • 1245.20.35306 Boehringer Ingelheim Investigational Site
  • 1245.20.81007 Boehringer Ingelheim Investigational Site
  • 1245.20.81001 Boehringer Ingelheim Investigational Site
  • 1245.20.81002 Boehringer Ingelheim Investigational Site
  • 1245.20.81005 Boehringer Ingelheim Investigational Site
  • 1245.20.81004 Boehringer Ingelheim Investigational Site
  • 1245.20.81003 Boehringer Ingelheim Investigational Site
  • 1245.20.81006 Boehringer Ingelheim Investigational Site
  • 1245.20.81008 Boehringer Ingelheim Investigational Site
  • 1245.20.81009 Boehringer Ingelheim Investigational Site
  • 1245.20.81010 Boehringer Ingelheim Investigational Site
  • 1245.20.81012 Boehringer Ingelheim Investigational Site
  • 1245.20.81013 Boehringer Ingelheim Investigational Site
  • 1245.20.41004 Boehringer Ingelheim Investigational Site
  • 1245.20.41003 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Placebo Comparator

Active Comparator

Experimental

Arm Label

BI 10773 low dose

BI 10773 high dose

Placebo

Sitagliptin 100 mg

BI 10773 high dose open label

Arm Description

Patients receive BI 10773 low dose tablets once daily

Patients receive BI 10773 high dose tablets once daily

Patients receive tablets identical to those containing BI 10773 low dose and high dose and to Sitagliptin

Patients receive Sitagliptin 100 mg tablets once daily

Patients receive BI 10773 high dose tablets open label once daily

Outcomes

Primary Outcome Measures

Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 24 Weeks
The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm). In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive.

Secondary Outcome Measures

Change From Baseline to Week 24 in Body Weight
The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm). In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive.
Change From Baseline to Week 24 in Systolic and Diastolic Blood Pressure (SBP and DBP)
The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm). In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive. For blood pressure, data following changes in antihypertensive therapy is censored, in the same way that data following initiation of rescue medication is censored.

Full Information

First Posted
July 29, 2010
Last Updated
May 16, 2014
Sponsor
Boehringer Ingelheim
Collaborators
Eli Lilly and Company
search

1. Study Identification

Unique Protocol Identification Number
NCT01177813
Brief Title
Efficacy and Safety of Empagliflozin (BI 10773) Versus Placebo and Sitagliptin 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 and Sitagliptin Administered Orally Over 24 Weeks, in Drug naïve Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Diet and Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
March 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 aim of this study is to investigate the efficacy, safety and tolerability of BI 10773 compared to placebo and sitagliptin given for 24 weeks as monotherapy in patients with T2DM with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 10773 when given for 24 weeks in patients with T2DM with very poor 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
986 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BI 10773 low dose
Arm Type
Experimental
Arm Description
Patients receive BI 10773 low dose tablets once daily
Arm Title
BI 10773 high dose
Arm Type
Experimental
Arm Description
Patients receive BI 10773 high dose tablets once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients receive tablets identical to those containing BI 10773 low dose and high dose and to Sitagliptin
Arm Title
Sitagliptin 100 mg
Arm Type
Active Comparator
Arm Description
Patients receive Sitagliptin 100 mg tablets once daily
Arm Title
BI 10773 high dose open label
Arm Type
Experimental
Arm Description
Patients receive BI 10773 high dose tablets open label once daily
Intervention Type
Drug
Intervention Name(s)
Placebo identical to BI10773 high dose
Intervention Description
placebo tablets once daily
Intervention Type
Drug
Intervention Name(s)
BI 10773
Intervention Description
BI 10773 low dose tablet once daily
Intervention Type
Drug
Intervention Name(s)
BI 10773 open label
Intervention Description
Patients receive BI 10773 high dose tablets open label once daily
Intervention Type
Drug
Intervention Name(s)
Placebo identical to BI10773 low dose
Intervention Description
placebo tablets once daily
Intervention Type
Drug
Intervention Name(s)
Placebo identical to BI10773 low dose
Intervention Description
placebo tablets once daily
Intervention Type
Drug
Intervention Name(s)
Placebo identical to BI10773 high dose
Intervention Description
placebo tablets once daily
Intervention Type
Drug
Intervention Name(s)
Placebo identical to Sitagliptin 100mg
Intervention Description
placebo tablets once daily
Intervention Type
Drug
Intervention Name(s)
Placebo identical to Sitagliptin 100mg
Intervention Description
placebo tablets once daily
Intervention Type
Drug
Intervention Name(s)
BI10773
Intervention Description
BI 10773 high dose tablets once daily
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Intervention Description
Sitagliptin tablets 100 mg once daily
Intervention Type
Drug
Intervention Name(s)
Placebo identical to Sitagliptin 100mg
Intervention Description
placebo tablets once daily
Intervention Type
Drug
Intervention Name(s)
Placebo identical to BI10773 low dose
Intervention Description
placebo tablets once daily
Intervention Type
Drug
Intervention Name(s)
Placebo identical to BI10773 high dose
Intervention Description
placebo tablets once daily
Primary Outcome Measure Information:
Title
Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 24 Weeks
Description
The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm). In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive.
Time Frame
Baseline and day 169
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 24 in Body Weight
Description
The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm). In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive.
Time Frame
Baseline and day 169
Title
Change From Baseline to Week 24 in Systolic and Diastolic Blood Pressure (SBP and DBP)
Description
The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm). In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive. For blood pressure, data following changes in antihypertensive therapy is censored, in the same way that data following initiation of rescue medication is censored.
Time Frame
Baseline and week 24
Other Pre-specified Outcome Measures:
Title
Confirmed Hypoglycaemic Adverse Events
Description
Confirmed hypoglycaemic events refer to all hypoglycaemic events, that had a glucose value <= 70 ml/dL or where assistance was required. Symptomatic hypoglycaemic events were to be reported as adverse events. Patients can be counted in more than one category.
Time Frame
From first drug intake until 7 days after last medication intake, up to 219 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 diet and exercise regimen who are drug-naïve; HbA1c >= 7.0% and <= 10.0% at Visit 1 (screening) for randomised treatment; HbA1c > 10.0% at visit 1 (screening) for the open-label BI 10773 arm; Age >= 20 (Japan); Age >= 18 (countries other than Japan); BMI <= 45 kg/m2 at Visit 1 (screening); Signed and dated written informed consent by date of Visit 1 Exclusion criteria: Uncontrolled hyperglycaemia; Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent; Indication of liver disease, either ALT, AST, or alkaline phosphatase above 3 x ULN; Impaired renal function (eGFR<50 ml/min); Bariatric surgery within the past two years or other GI surgeries; Medical history of cancer; Contraindications to sitagliptin; Blood dyscrasias or any disorders causing haemolysis or unstable red blood cell; Treatment with any anti-diabetes drug within 12 weeks prior to randomisation; Treatment with anti-obesity drugs or any other treatment leading to unstable body weight; Current treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM; Pre-menopausal women who are nursing or pregnant or are of child-bearing potential and not practicing an acceptable method of birth control; Alcohol or drug abuse; Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial; 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
1245.20.10124 Boehringer Ingelheim Investigational Site
City
Mesa
State/Province
Arizona
Country
United States
Facility Name
1245.20.10108 Boehringer Ingelheim Investigational Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
1245.20.10150 Boehringer Ingelheim Investigational Site
City
Hot Springs
State/Province
Arkansas
Country
United States
Facility Name
1245.20.10154 Boehringer Ingelheim Investigational Site
City
Chino
State/Province
California
Country
United States
Facility Name
1245.20.10009 Boehringer Ingelheim Investigational Site
City
Santa Ana
State/Province
California
Country
United States
Facility Name
1245.20.10131 Boehringer Ingelheim Investigational Site
City
West Hills
State/Province
California
Country
United States
Facility Name
1245.20.10038 Boehringer Ingelheim Investigational Site
City
Northglenn
State/Province
Colorado
Country
United States
Facility Name
1245.20.10137 Boehringer Ingelheim Investigational Site
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
1245.20.10006 Boehringer Ingelheim Investigational Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
1245.20.10085 Boehringer Ingelheim Investigational Site
City
Plantation
State/Province
Florida
Country
United States
Facility Name
1245.20.10078 Boehringer Ingelheim Investigational Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
1245.20.10080 Boehringer Ingelheim Investigational Site
City
Decatur
State/Province
Georgia
Country
United States
Facility Name
1245.20.10128 Boehringer Ingelheim Investigational Site
City
Avon
State/Province
Indiana
Country
United States
Facility Name
1245.20.10060 Boehringer Ingelheim Investigational Site
City
Fishers
State/Province
Indiana
Country
United States
Facility Name
1245.20.10065 Boehringer Ingelheim Investigational Site
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
1245.20.10117 Boehringer Ingelheim Investigational Site
City
Arkansas City
State/Province
Kansas
Country
United States
Facility Name
1245.20.10039 Boehringer Ingelheim Investigational Site
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
1245.20.10146 Boehringer Ingelheim Investigational Site
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
1245.20.10144 Boehringer Ingelheim Investigational Site
City
Watertown
State/Province
Massachusetts
Country
United States
Facility Name
1245.20.10115 Boehringer Ingelheim Investigational Site
City
Brick
State/Province
New Jersey
Country
United States
Facility Name
1245.20.10129 Boehringer Ingelheim Investigational Site
City
Carlisle
State/Province
Ohio
Country
United States
Facility Name
1245.20.10045 Boehringer Ingelheim Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
1245.20.10119 Boehringer Ingelheim Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
1245.20.10130 Boehringer Ingelheim Investigational Site
City
Gallipolis
State/Province
Ohio
Country
United States
Facility Name
1245.20.10089 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1245.20.10151 Boehringer Ingelheim Investigational Site
City
Hurst
State/Province
Texas
Country
United States
Facility Name
1245.20.10155 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
1245.20.32008 Boehringer Ingelheim Investigational Site
City
Bruxelles
Country
Belgium
Facility Name
1245.20.32011 Boehringer Ingelheim Investigational Site
City
Bruxelles
Country
Belgium
Facility Name
1245.20.32023 Boehringer Ingelheim Investigational Site
City
Bruxelles
Country
Belgium
Facility Name
1245.20.32003 Boehringer Ingelheim Investigational Site
City
De Pinte
Country
Belgium
Facility Name
1245.20.32015 Boehringer Ingelheim Investigational Site
City
Deurne
Country
Belgium
Facility Name
1245.20.32016 Boehringer Ingelheim Investigational Site
City
Deurne
Country
Belgium
Facility Name
1245.20.32025 Boehringer Ingelheim Investigational Site
City
Gozée
Country
Belgium
Facility Name
1245.20.32022 Boehringer Ingelheim Investigational Site
City
Landen
Country
Belgium
Facility Name
1245.20.32019 Boehringer Ingelheim Investigational Site
City
Leopoldsburg
Country
Belgium
Facility Name
1245.20.32024 Boehringer Ingelheim Investigational Site
City
Linkebeek
Country
Belgium
Facility Name
1245.20.32021 Boehringer Ingelheim Investigational Site
City
Mouscron
Country
Belgium
Facility Name
1245.20.32027 Boehringer Ingelheim Investigational Site
City
Retie
Country
Belgium
Facility Name
1245.20.32020 Boehringer Ingelheim Investigational Site
City
Sint-Gillis-Waas
Country
Belgium
Facility Name
1245.20.32018 Boehringer Ingelheim Investigational Site
City
Tielt
Country
Belgium
Facility Name
1245.20.32026 Boehringer Ingelheim Investigational Site
City
Tremelo
Country
Belgium
Facility Name
1245.20.20011 Boehringer Ingelheim Investigational Site
City
Chilliwack
State/Province
British Columbia
Country
Canada
Facility Name
1245.20.20018 Boehringer Ingelheim Investigational Site
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
1245.20.20015 Boehringer Ingelheim Investigational Site
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
1245.20.20012 Boehringer Ingelheim Investigational Site
City
Moncton
State/Province
New Brunswick
Country
Canada
Facility Name
1245.20.20016 Boehringer Ingelheim Investigational Site
City
Mount Pearl
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
1245.20.20008 Boehringer Ingelheim Investigational Site
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
1245.20.20001 Boehringer Ingelheim Investigational Site
City
Barrie
State/Province
Ontario
Country
Canada
Facility Name
1245.20.20019 Boehringer Ingelheim Investigational Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
1245.20.20010 Boehringer Ingelheim Investigational Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
1245.20.20017 Boehringer Ingelheim Investigational Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
1245.20.20003 Boehringer Ingelheim Investigational Site
City
Markham
State/Province
Ontario
Country
Canada
Facility Name
1245.20.20009 Boehringer Ingelheim Investigational Site
City
Newmarket
State/Province
Ontario
Country
Canada
Facility Name
1245.20.20013 Boehringer Ingelheim Investigational Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
1245.20.20005 Boehringer Ingelheim Investigational Site
City
Strathroy
State/Province
Ontario
Country
Canada
Facility Name
1245.20.20002 Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1245.20.20006 Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1245.20.20014 Boehringer Ingelheim Investigational Site
City
Charlottetown
State/Province
Prince Edward Island
Country
Canada
Facility Name
1245.20.20007 Boehringer Ingelheim Investigational Site
City
Montague
State/Province
Prince Edward Island
Country
Canada
Facility Name
1245.20.20021 Boehringer Ingelheim Investigational Site
City
Trois Rivieres
State/Province
Quebec
Country
Canada
Facility Name
1245.20.86007 Boehringer Ingelheim Investigational Site
City
Beijing
Country
China
Facility Name
1245.20.86008 Boehringer Ingelheim Investigational Site
City
Beijing
Country
China
Facility Name
1245.20.86001 Boehringer Ingelheim Investigational Site
City
Guangzhou
Country
China
Facility Name
1245.20.86002 Boehringer Ingelheim Investigational Site
City
Guangzhou
Country
China
Facility Name
1245.20.86003 Boehringer Ingelheim Investigational Site
City
Guangzhou
Country
China
Facility Name
1245.20.86012 Boehringer Ingelheim Investigational Site
City
Guiyang
Country
China
Facility Name
1245.20.86020 Boehringer Ingelheim Investigational Site
City
Hangzhou
Country
China
Facility Name
1245.20.86049 Boehringer Ingelheim Investigational Site
City
Jinan
Country
China
Facility Name
1245.20.86018 Boehringer Ingelheim Investigational Site
City
Jingzhou
Country
China
Facility Name
1245.20.86019 Boehringer Ingelheim Investigational Site
City
Nanchang
Country
China
Facility Name
1245.20.86010 Boehringer Ingelheim Investigational Site
City
Nanjing
Country
China
Facility Name
1245.20.86043 Boehringer Ingelheim Investigational Site
City
Nanjing
Country
China
Facility Name
1245.20.86016 Boehringer Ingelheim Investigational Site
City
QingDao
Country
China
Facility Name
1245.20.86004 Boehringer Ingelheim Investigational Site
City
Shanghai
Country
China
Facility Name
1245.20.86005 Boehringer Ingelheim Investigational Site
City
Shanghai
Country
China
Facility Name
1245.20.86006 Boehringer Ingelheim Investigational Site
City
Shanghai
Country
China
Facility Name
1245.20.86057 Boehringer Ingelheim Investigational Site
City
Shenyang
Country
China
Facility Name
1245.20.86017 Boehringer Ingelheim Investigational Site
City
Shiyan
Country
China
Facility Name
1245.20.86013 Boehringer Ingelheim Investigational Site
City
Suzhou
Country
China
Facility Name
1245.20.86015 Boehringer Ingelheim Investigational Site
City
Taiyuan
Country
China
Facility Name
1245.20.86009 Boehringer Ingelheim Investigational Site
City
Wuhan
Country
China
Facility Name
1245.20.86011 Boehringer Ingelheim Investigational Site
City
Xi'An
Country
China
Facility Name
1245.20.86014 Boehringer Ingelheim Investigational Site
City
Xiamen
Country
China
Facility Name
1245.20.49013 Boehringer Ingelheim Investigational Site
City
Dresden
Country
Germany
Facility Name
1245.20.49016 Boehringer Ingelheim Investigational Site
City
Düsseldorf
Country
Germany
Facility Name
1245.20.49015 Boehringer Ingelheim Investigational Site
City
Frankfurt
Country
Germany
Facility Name
1245.20.49019 Boehringer Ingelheim Investigational Site
City
Haag
Country
Germany
Facility Name
1245.20.49020 Boehringer Ingelheim Investigational Site
City
Hohenmölsen
Country
Germany
Facility Name
1245.20.49014 Boehringer Ingelheim Investigational Site
City
Köthen
Country
Germany
Facility Name
1245.20.49002 Boehringer Ingelheim Investigational Site
City
Neuwied
Country
Germany
Facility Name
1245.20.49008 Boehringer Ingelheim Investigational Site
City
Nürnberg
Country
Germany
Facility Name
1245.20.49022 Boehringer Ingelheim Investigational Site
City
Schauenburg
Country
Germany
Facility Name
1245.20.49017 Boehringer Ingelheim Investigational Site
City
St. Ingbert/Oberwürzbach
Country
Germany
Facility Name
1245.20.49003 Boehringer Ingelheim Investigational Site
City
Unterschneidheim
Country
Germany
Facility Name
1245.20.91005 Boehringer Ingelheim Investigational Site
City
Bangalore
Country
India
Facility Name
1245.20.91006 Boehringer Ingelheim Investigational Site
City
Bangalore
Country
India
Facility Name
1245.20.91008 Boehringer Ingelheim Investigational Site
City
Bangalore
Country
India
Facility Name
1245.20.91003 Boehringer Ingelheim Investigational Site
City
Belgaum
Country
India
Facility Name
1245.20.91004 Boehringer Ingelheim Investigational Site
City
Chennai
Country
India
Facility Name
1245.20.91009 Boehringer Ingelheim Investigational Site
City
Chennai
Country
India
Facility Name
1245.20.91007 Boehringer Ingelheim Investigational Site
City
Mumbai, Maharastra
Country
India
Facility Name
1245.20.91002 Boehringer Ingelheim Investigational Site
City
Mumbai
Country
India
Facility Name
1245.20.91010 Boehringer Ingelheim Investigational Site
City
Nagpur
Country
India
Facility Name
1245.20.91001 Boehringer Ingelheim Investigational Site
City
Tamil Nadu
Country
India
Facility Name
1245.20.35302 Boehringer Ingelheim Investigational Site
City
Co. Cork
Country
Ireland
Facility Name
1245.20.35305 Boehringer Ingelheim Investigational Site
City
Co. Galway
Country
Ireland
Facility Name
1245.20.35303 Boehringer Ingelheim Investigational Site
City
Co. Wexford
Country
Ireland
Facility Name
1245.20.35304 Boehringer Ingelheim Investigational Site
City
Offaly
Country
Ireland
Facility Name
1245.20.35306 Boehringer Ingelheim Investigational Site
City
Wexford
Country
Ireland
Facility Name
1245.20.81007 Boehringer Ingelheim Investigational Site
City
Chiyoda-ku, Tokyo
Country
Japan
Facility Name
1245.20.81001 Boehringer Ingelheim Investigational Site
City
Chuo-ku, Tokyo
Country
Japan
Facility Name
1245.20.81002 Boehringer Ingelheim Investigational Site
City
Chuo-ku, Tokyo
Country
Japan
Facility Name
1245.20.81005 Boehringer Ingelheim Investigational Site
City
Ebetsu, Hokkaido
Country
Japan
Facility Name
1245.20.81004 Boehringer Ingelheim Investigational Site
City
Kamakura, Kanagawa
Country
Japan
Facility Name
1245.20.81003 Boehringer Ingelheim Investigational Site
City
Minato-ku, Tokyo
Country
Japan
Facility Name
1245.20.81006 Boehringer Ingelheim Investigational Site
City
Shinjuku-ku, Tokyo
Country
Japan
Facility Name
1245.20.81008 Boehringer Ingelheim Investigational Site
City
Shinjuku-ku, Tokyo
Country
Japan
Facility Name
1245.20.81009 Boehringer Ingelheim Investigational Site
City
Suita, Osaka
Country
Japan
Facility Name
1245.20.81010 Boehringer Ingelheim Investigational Site
City
Ube, Yamaguchi
Country
Japan
Facility Name
1245.20.81012 Boehringer Ingelheim Investigational Site
City
Urasoe, Okinawa
Country
Japan
Facility Name
1245.20.81013 Boehringer Ingelheim Investigational Site
City
Urasoe, Okinawa
Country
Japan
Facility Name
1245.20.41004 Boehringer Ingelheim Investigational Site
City
Lugano
Country
Switzerland
Facility Name
1245.20.41003 Boehringer Ingelheim Investigational Site
City
Rorschach
Country
Switzerland

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
24622369
Citation
Roden M, Weng J, Eilbracht J, Delafont B, Kim G, Woerle HJ, Broedl UC; EMPA-REG MONO trial investigators. Empagliflozin monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2013 Nov;1(3):208-19. doi: 10.1016/S2213-8587(13)70084-6. Epub 2013 Sep 9.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1245/1245.20_U12-1517-01-DS.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1245/1245.20_Literature.pdf
Description
Related Info

Learn more about this trial

Efficacy and Safety of Empagliflozin (BI 10773) Versus Placebo and Sitagliptin Over 24 Weeks in Patients With Type 2 Diabetes

We'll reach out to this number within 24 hrs