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Efficacy and Safety of Empagliflozin (BI 10773) in Type 2 Diabetes Patients on a Background of Pioglitazone Alone or With Metformin

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
BI 10773
Placebo
Placebo
Placebo
BI 10773
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 pre-treated with pioglitazone alone or in combination with metformin. The treatment regimen should be unchanged for 12 weeks prior to randomisation.
  3. HbA1c of >/= 7.0% and </= 10.0% at Visit 1 (screening).
  4. Age >/= 18.
  5. BMI </= 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 medication within 12 weeks prior to randomisation, except those defined as the permitted background therapy via inclusion criteria no. 2.
  3. Myocardial infarction, stroke or transient ischaemic attack (TIA) within 3 months prior to informed consent.
  4. Indication of liver disease, defined by serum levels of either alanine transaminase (ALT/SGPT), aspartate transaminase (AST/SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening or during the placebo run-in period (i.e. at a visit prior to the randomisation visit, Visit 3).
  5. Impaired renal function, defined as eGFR (estimated Glomerular Filtration Rate) < 30 ml/min (severe renal impairment, MDRD [Modification of Diet in Renal Disease] formula) as determined during screening or during the placebo run-in period (i.e. at a visit prior to the randomisation visit, Visit 3).
  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. Blood dyscrasias or any disorders causing haemolysis or unstable red blood cells (e.g. malaria, babesiosis, haemolytic anaemia).
  9. Contraindications to pioglitazone according to the local label.
  10. Contraindication to pioglitazone and/or metformin (relevant only for those patients who enter the study with both these background therapies) according to the local labels.
  11. 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.
  12. 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 T2D.

  13. 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 trial 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 to local authorities), double barrier method and vasectomised partner.
  14. 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.
  15. Participation in another trial with an investigational drug within 30 days prior to informed consent.
  16. Any other clinical condition that would jeopardise patient safety while participating in this clinical trial.

Sites / Locations

  • 1245.19.10056 Boehringer Ingelheim Investigational Site
  • 1245.19.10162 Boehringer Ingelheim Investigational Site
  • 1245.19.10161 Boehringer Ingelheim Investigational Site
  • 1245.19.10046 Boehringer Ingelheim Investigational Site
  • 1245.19.10070 Boehringer Ingelheim Investigational Site
  • 1245.19.10047 Boehringer Ingelheim Investigational Site
  • 1245.19.10149 Boehringer Ingelheim Investigational Site
  • 1245.19.10163 Boehringer Ingelheim Investigational Site
  • 1245.19.10131 Boehringer Ingelheim Investigational Site
  • 1245.19.10141 Boehringer Ingelheim Investigational Site
  • 1245.19.10133 Boehringer Ingelheim Investigational Site
  • 1245.19.10085 Boehringer Ingelheim Investigational Site
  • 1245.19.10077 Boehringer Ingelheim Investigational Site
  • 1245.19.10014 Boehringer Ingelheim Investigational Site
  • 1245.19.10160 Boehringer Ingelheim Investigational Site
  • 1245.19.10003 Boehringer Ingelheim Investigational Site
  • 1245.19.10059 Boehringer Ingelheim Investigational Site
  • 1245.19.10123 Boehringer Ingelheim Investigational Site
  • 1245.19.10071 Boehringer Ingelheim Investigational Site
  • 1245.19.10086 Boehringer Ingelheim Investigational Site
  • 1245.19.10008 Boehringer Ingelheim Investigational Site
  • 1245.19.10033 Boehringer Ingelheim Investigational Site
  • 1245.19.10112 Boehringer Ingelheim Investigational Site
  • 1245.19.10002 Boehringer Ingelheim Investigational Site
  • 1245.19.20047 Boehringer Ingelheim Investigational Site
  • 1245.19.20062 Boehringer Ingelheim Investigational Site
  • 1245.19.20012 G.A. Research Associates Ltd.
  • 1245.19.20031 Boehringer Ingelheim Investigational Site
  • 1245.19.20057 Boehringer Ingelheim Investigational Site
  • 1245.19.20059 Boehringer Ingelheim Investigational Site
  • 1245.19.20060 Boehringer Ingelheim Investigational Site
  • 1245.19.20009 Boehringer Ingelheim Investigational Site
  • 1245.19.20034 Boehringer Ingelheim Investigational Site
  • 1245.19.20058 Boehringer Ingelheim Investigational Site
  • 1245.19.20041 Boehringer Ingelheim Investigational Site
  • 1245.19.30002 Boehringer Ingelheim Investigational Site
  • 1245.19.30001 Boehringer Ingelheim Investigational Site
  • 1245.19.30004 Boehringer Ingelheim Investigational Site
  • 1245.19.91005 Boehringer Ingelheim Investigational Site
  • 1245.19.91006 Boehringer Ingelheim Investigational Site
  • 1245.19.91008 Boehringer Ingelheim Investigational Site
  • 1245.19.91003 Boehringer Ingelheim Investigational Site
  • 1245.19.91004 Boehringer Ingelheim Investigational Site
  • 1245.19.91009 Boehringer Ingelheim Investigational Site
  • 1245.19.91001 Boehringer Ingelheim Investigational Site
  • 1245.19.91015 Boehringer Ingelheim Investigational Site
  • 1245.19.91011 Boehringer Ingelheim Investigational Site
  • 1245.19.91007 Boehringer Ingelheim Investigational Site
  • 1245.19.91002 Boehringer Ingelheim Investigational Site
  • 1245.19.91017 Boehringer Ingelheim Investigational Site
  • 1245.19.91010 Boehringer Ingelheim Investigational Site
  • 1245.19.91012 Boehringer Ingelheim Investigational Site
  • 1245.19.91013 Boehringer Ingelheim Investigational Site
  • 1245.19.91014 Boehringer Ingelheim Investigational Site
  • 1245.19.91016 Boehringer Ingelheim Investigational Site
  • 1245.19.63002 Boehringer Ingelheim Investigational Site
  • 1245.19.63003 Boehringer Ingelheim Investigational Site
  • 1245.19.63004 Boehringer Ingelheim Investigational Site
  • 1245.19.63005 Boehringer Ingelheim Investigational Site
  • 1245.19.63001 Boehringer Ingelheim Investigational Site
  • 1245.19.66003 Boehringer Ingelheim Investigational Site
  • 1245.19.66004 Boehringer Ingelheim Investigational Site
  • 1245.19.75002 Boehringer Ingelheim Investigational Site
  • 1245.19.75001 Boehringer Ingelheim Investigational Site
  • 1245.19.75005 Boehringer Ingelheim Investigational Site
  • 1245.19.75006 Boehringer Ingelheim Investigational Site
  • 1245.19.75004 Boehringer Ingelheim Investigational Site
  • 1245.19.75003 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

BI 10773 low dose

BI 10773 high dose

Placebo

Arm Description

BI 10773 tablets once daily

BI 10773 tablets once daily

Placebo tablets matching BI 10773

Outcomes

Primary Outcome Measures

HbA1c Change From Baseline
Change From Baseline in HbA1c after 24 weeks. Note that adjusted means are provided.
HbA1c Change From Baseline for Pio and Met Background Medication Patients
Change From Baseline in HbA1c after 24 weeks for patients with pioglitazone (pio) and metformin (met) background medication only. Note that adjusted means are provided.

Secondary Outcome Measures

Fasting Plasma Glucose (FPG) Change From Baseline
Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment. Note that adjusted means are provided.
Body Weight Change From Baseline
Change from baseline in body weight after 24 weeks. Note that adjusted means are provided.

Full Information

First Posted
September 27, 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
NCT01210001
Brief Title
Efficacy and Safety of Empagliflozin (BI 10773) in Type 2 Diabetes Patients on a Background of Pioglitazone Alone or With Metformin
Official Title
A Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Trial of BI 10773 (10 and 25 mg Administered Orally Once Daily) Over 24 Weeks in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite a Background Therapy of Pioglitazone Alone or in Combination With Metformin
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
April 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
This study will investigate the efficacy and safety of BI 10773 in type 2 diabetic patients in order to provide these data for approval for BI 10773 by regulatory authorities as an antidiabetic agent as add-on therapy to pioglitazone alone or in combination with metformin.

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
499 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BI 10773 low dose
Arm Type
Experimental
Arm Description
BI 10773 tablets once daily
Arm Title
BI 10773 high dose
Arm Type
Experimental
Arm Description
BI 10773 tablets once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets matching BI 10773
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets matching BI 10773 low dose
Intervention Type
Drug
Intervention Name(s)
BI 10773
Intervention Description
BI 10773 tablets once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets matching BI 10773 high dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets matching BI 10773 high dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets matching BI 10773 high dose
Intervention Type
Drug
Intervention Name(s)
BI 10773
Intervention Description
BI 10773 tablets once daily
Primary Outcome Measure Information:
Title
HbA1c Change From Baseline
Description
Change From Baseline in HbA1c after 24 weeks. Note that adjusted means are provided.
Time Frame
Baseline and 24 weeks
Title
HbA1c Change From Baseline for Pio and Met Background Medication Patients
Description
Change From Baseline in HbA1c after 24 weeks for patients with pioglitazone (pio) and metformin (met) background medication only. Note that adjusted means are provided.
Time Frame
Baseline and 24 weeks
Secondary Outcome Measure Information:
Title
Fasting Plasma Glucose (FPG) Change From Baseline
Description
Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment. Note that adjusted means are provided.
Time Frame
Baseline and 24 weeks
Title
Body Weight Change From Baseline
Description
Change from baseline in body weight after 24 weeks. Note that adjusted means are provided.
Time Frame
Baseline and 24 weeks
Other Pre-specified Outcome Measures:
Title
Hypoglycaemic Events
Description
Number of patients with hypoglycaemic events, as reported as adverse events.
Time Frame
From first drug administration until 7 days after last intake of study drug, up to 256 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 pre-treated with pioglitazone alone or in combination with metformin. The treatment regimen should be unchanged for 12 weeks prior to randomisation. HbA1c of >/= 7.0% and </= 10.0% at Visit 1 (screening). Age >/= 18. BMI </= 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 medication within 12 weeks prior to randomisation, except those defined as the permitted background therapy via inclusion criteria no. 2. Myocardial infarction, stroke or transient ischaemic attack (TIA) within 3 months prior to informed consent. Indication of liver disease, defined by serum levels of either alanine transaminase (ALT/SGPT), aspartate transaminase (AST/SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening or during the placebo run-in period (i.e. at a visit prior to the randomisation visit, Visit 3). Impaired renal function, defined as eGFR (estimated Glomerular Filtration Rate) < 30 ml/min (severe renal impairment, MDRD [Modification of Diet in Renal Disease] formula) as determined during screening or during the placebo run-in period (i.e. at a visit prior to the randomisation visit, Visit 3). 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 . Blood dyscrasias or any disorders causing haemolysis or unstable red blood cells (e.g. malaria, babesiosis, haemolytic anaemia). Contraindications to pioglitazone according to the local label. Contraindication to pioglitazone and/or metformin (relevant only for those patients who enter the study with both these background therapies) according to the local labels. 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 T2D. 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 trial 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 to 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 jeopardise patient 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
1245.19.10056 Boehringer Ingelheim Investigational Site
City
Muscle Shoals
State/Province
Alabama
Country
United States
Facility Name
1245.19.10162 Boehringer Ingelheim Investigational Site
City
Glendale
State/Province
Arizona
Country
United States
Facility Name
1245.19.10161 Boehringer Ingelheim Investigational Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
1245.19.10046 Boehringer Ingelheim Investigational Site
City
Tempe
State/Province
Arizona
Country
United States
Facility Name
1245.19.10070 Boehringer Ingelheim Investigational Site
City
Irvine
State/Province
California
Country
United States
Facility Name
1245.19.10047 Boehringer Ingelheim Investigational Site
City
La Mesa
State/Province
California
Country
United States
Facility Name
1245.19.10149 Boehringer Ingelheim Investigational Site
City
Rancho Cucamonga
State/Province
California
Country
United States
Facility Name
1245.19.10163 Boehringer Ingelheim Investigational Site
City
Riverside
State/Province
California
Country
United States
Facility Name
1245.19.10131 Boehringer Ingelheim Investigational Site
City
West Hills
State/Province
California
Country
United States
Facility Name
1245.19.10141 Boehringer Ingelheim Investigational Site
City
Milford
State/Province
Connecticut
Country
United States
Facility Name
1245.19.10133 Boehringer Ingelheim Investigational Site
City
Jupiter
State/Province
Florida
Country
United States
Facility Name
1245.19.10085 Boehringer Ingelheim Investigational Site
City
Plantation
State/Province
Florida
Country
United States
Facility Name
1245.19.10077 Boehringer Ingelheim Investigational Site
City
Perry
State/Province
Georgia
Country
United States
Facility Name
1245.19.10014 Boehringer Ingelheim Investigational Site
City
Dubuque
State/Province
Iowa
Country
United States
Facility Name
1245.19.10160 Boehringer Ingelheim Investigational Site
City
Essex
State/Province
Maryland
Country
United States
Facility Name
1245.19.10003 Boehringer Ingelheim Investigational Site
City
Dearborn
State/Province
Michigan
Country
United States
Facility Name
1245.19.10059 Boehringer Ingelheim Investigational Site
City
New Hyde Park
State/Province
New York
Country
United States
Facility Name
1245.19.10123 Boehringer Ingelheim Investigational Site
City
Smithtown
State/Province
New York
Country
United States
Facility Name
1245.19.10071 Boehringer Ingelheim Investigational Site
City
Asheboro
State/Province
North Carolina
Country
United States
Facility Name
1245.19.10086 Boehringer Ingelheim Investigational Site
City
Salisbury
State/Province
North Carolina
Country
United States
Facility Name
1245.19.10008 Boehringer Ingelheim Investigational Site
City
Marion
State/Province
Ohio
Country
United States
Facility Name
1245.19.10033 Boehringer Ingelheim Investigational Site
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
1245.19.10112 Boehringer Ingelheim Investigational Site
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
1245.19.10002 Boehringer Ingelheim Investigational Site
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
1245.19.20047 Boehringer Ingelheim Investigational Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
1245.19.20062 Boehringer Ingelheim Investigational Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
1245.19.20012 G.A. Research Associates Ltd.
City
Moncton
State/Province
New Brunswick
Country
Canada
Facility Name
1245.19.20031 Boehringer Ingelheim Investigational Site
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
1245.19.20057 Boehringer Ingelheim Investigational Site
City
Brampton
State/Province
Ontario
Country
Canada
Facility Name
1245.19.20059 Boehringer Ingelheim Investigational Site
City
Fort Erie
State/Province
Ontario
Country
Canada
Facility Name
1245.19.20060 Boehringer Ingelheim Investigational Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
1245.19.20009 Boehringer Ingelheim Investigational Site
City
Newmarket
State/Province
Ontario
Country
Canada
Facility Name
1245.19.20034 Boehringer Ingelheim Investigational Site
City
Sarnia
State/Province
Ontario
Country
Canada
Facility Name
1245.19.20058 Boehringer Ingelheim Investigational Site
City
St-Romuald
State/Province
Quebec
Country
Canada
Facility Name
1245.19.20041 Boehringer Ingelheim Investigational Site
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
1245.19.30002 Boehringer Ingelheim Investigational Site
City
Athens
Country
Greece
Facility Name
1245.19.30001 Boehringer Ingelheim Investigational Site
City
Nikaia
Country
Greece
Facility Name
1245.19.30004 Boehringer Ingelheim Investigational Site
City
Thessaloniki
Country
Greece
Facility Name
1245.19.91005 Boehringer Ingelheim Investigational Site
City
Bangalore
Country
India
Facility Name
1245.19.91006 Boehringer Ingelheim Investigational Site
City
Bangalore
Country
India
Facility Name
1245.19.91008 Boehringer Ingelheim Investigational Site
City
Bangalore
Country
India
Facility Name
1245.19.91003 Boehringer Ingelheim Investigational Site
City
Belgaum
Country
India
Facility Name
1245.19.91004 Boehringer Ingelheim Investigational Site
City
Chennai
Country
India
Facility Name
1245.19.91009 Boehringer Ingelheim Investigational Site
City
Chennai
Country
India
Facility Name
1245.19.91001 Boehringer Ingelheim Investigational Site
City
Coimbatore
Country
India
Facility Name
1245.19.91015 Boehringer Ingelheim Investigational Site
City
Gulbarga
Country
India
Facility Name
1245.19.91011 Boehringer Ingelheim Investigational Site
City
Kartanaka
Country
India
Facility Name
1245.19.91007 Boehringer Ingelheim Investigational Site
City
Mumbai, Maharastra
Country
India
Facility Name
1245.19.91002 Boehringer Ingelheim Investigational Site
City
Mumbai
Country
India
Facility Name
1245.19.91017 Boehringer Ingelheim Investigational Site
City
Mysore
Country
India
Facility Name
1245.19.91010 Boehringer Ingelheim Investigational Site
City
Nagpur
Country
India
Facility Name
1245.19.91012 Boehringer Ingelheim Investigational Site
City
New Delhi
Country
India
Facility Name
1245.19.91013 Boehringer Ingelheim Investigational Site
City
Patna
Country
India
Facility Name
1245.19.91014 Boehringer Ingelheim Investigational Site
City
Pune
Country
India
Facility Name
1245.19.91016 Boehringer Ingelheim Investigational Site
City
Pune
Country
India
Facility Name
1245.19.63002 Boehringer Ingelheim Investigational Site
City
Cebu City, N/A, Philippines
Country
Philippines
Facility Name
1245.19.63003 Boehringer Ingelheim Investigational Site
City
Davao City, N/A, Philippines
Country
Philippines
Facility Name
1245.19.63004 Boehringer Ingelheim Investigational Site
City
Manila, Philippines
Country
Philippines
Facility Name
1245.19.63005 Boehringer Ingelheim Investigational Site
City
Pasig City, Philippines
Country
Philippines
Facility Name
1245.19.63001 Boehringer Ingelheim Investigational Site
City
San Juan City, Philippines
Country
Philippines
Facility Name
1245.19.66003 Boehringer Ingelheim Investigational Site
City
Saimai
Country
Thailand
Facility Name
1245.19.66004 Boehringer Ingelheim Investigational Site
City
Udon Thani, Thailand
Country
Thailand
Facility Name
1245.19.75002 Boehringer Ingelheim Investigational Site
City
Dnepropetrovsk
Country
Ukraine
Facility Name
1245.19.75001 Boehringer Ingelheim Investigational Site
City
Kharkov
Country
Ukraine
Facility Name
1245.19.75005 Boehringer Ingelheim Investigational Site
City
Kiev
Country
Ukraine
Facility Name
1245.19.75006 Boehringer Ingelheim Investigational Site
City
Lviv
Country
Ukraine
Facility Name
1245.19.75004 Boehringer Ingelheim Investigational Site
City
Vinnitsa
Country
Ukraine
Facility Name
1245.19.75003 Boehringer Ingelheim Investigational Site
City
Vinnytsya
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
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
26138864
Citation
Kovacs CS, Seshiah V, Merker L, Christiansen AV, Roux F, Salsali A, Kim G, Stella P, Woerle HJ, Broedl UC; EMPA-REG EXTEND PIO investigators. Empagliflozin as Add-on Therapy to Pioglitazone With or Without Metformin in Patients With Type 2 Diabetes Mellitus. Clin Ther. 2015 Aug;37(8):1773-88.e1. doi: 10.1016/j.clinthera.2015.05.511. Epub 2015 Jun 29.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1245/1245.19_U12-1516-02.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1245/1245.19_Literature.pdf
Description
Related Info

Learn more about this trial

Efficacy and Safety of Empagliflozin (BI 10773) in Type 2 Diabetes Patients on a Background of Pioglitazone Alone or With Metformin

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