1 |
NCT01131676 |
Completed Has Results |
BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME). |
- Diabetes Mellitus, Type 2
|
- Drug: BI 10773 low dose
- Drug: Placebo BI 10773 high dose
- Drug: BI 10773 high dose
- Drug: Placebo BI 10773 low dose
|
Interventional
|
Phase 3 |
- Boehringer Ingelheim
- Eli Lilly and Company
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Time to the First Occurrence of Any of the Following Adjudicated Components of the Primary Composite Endpoint (3-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), and Non-fatal Stroke.
- Percentage of Participants With the Composite of All Events Adjudicated (4-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), Non-fatal Stroke and Hospitalization for Unstable Angina Pectoris
- Percentage of Participants With Silent MI
- (and 4 more...)
|
7064 |
All |
18 Years and older (Adult, Older Adult) |
NCT01131676 |
1245.25 2009-016178-33 |
|
July 2010 |
April 2015 |
April 2015 |
May 27, 2010 |
May 16, 2016 |
May 16, 2016 |
- 1245.25.10043 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States - 1245.25.10121 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States - 1245.25.10037 Boehringer Ingelheim Investigational Site
Huntsville, Alabama, United States - (and 612 more...)
|
|
2 |
NCT01306214 |
Completed Has Results |
Safety and Efficacy of BI 10773 as add-on to Insulin Regimen in Patients With Type 2 Diabetes Mellitus |
- Diabetes Mellitus, Type 2
- Obesity
|
- Drug: Placebo
- Drug: BI 10773
|
Interventional
|
Phase 3 |
- Boehringer Ingelheim
- Eli Lilly and Company
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Change From Baseline in HbA1c After 18 Weeks of Treatment
- Change From Baseline in Insulin Dose After 52 Weeks of Treatment
- Change From Baseline in Body Weight After 52 Weeks of Treatment
- Change From Baseline in HbA1c After 52 Weeks of Treatment
|
566 |
All |
18 Years and older (Adult, Older Adult) |
NCT01306214 |
1245.49 2010-019968-37 |
|
February 2011 |
April 2013 |
April 2013 |
March 1, 2011 |
June 17, 2014 |
June 17, 2014 |
- 1245.49.10005 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States - 1245.49.10011 Boehringer Ingelheim Investigational Site
Chandler, Arizona, United States - 1245.49.10004 Boehringer Ingelheim Investigational Site
Tucson, Arizona, United States - (and 100 more...)
|
|
3 |
NCT03057977 |
Recruiting |
EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced) |
|
- Drug: Empagliflozin
- Drug: Placebo
|
Interventional
|
Phase 3 |
- Boehringer Ingelheim
- Eli Lilly and Company
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Composite primary endpoint - Time to first event of adjudicated CV (Cardiovascular) death or adjudicated HHF (Hospitalisation for Heart Failure) in patients with Heart Failure with reduced Ejection Fraction (HFrEF)
- Occurrence of adjudicated HHF (Hospitalisation for Heart Failure) (first and recurrent)
- eGFR (Estimated Glomerular Filtration Rate) (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation))cr slope of change from baseline
- (and 7 more...)
|
2850 |
All |
18 Years and older (Adult, Older Adult) |
NCT03057977 |
1245.121 2016-002280-34 |
|
March 6, 2017 |
June 1, 2020 |
June 1, 2020 |
February 20, 2017 |
February 5, 2019 |
|
- Long Beach Center for Clinical Research
Long Beach, California, United States - Merced Vein and Vascular Center
Merced, California, United States - University of California Irvine
Orange, California, United States - (and 502 more...)
|
|
4 |
NCT03057951 |
Recruiting |
EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved) |
|
- Drug: Empagliflozin
- Drug: Placebo
|
Interventional
|
Phase 3 |
- Boehringer Ingelheim
- Eli Lilly and Company
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Composite primary endpoint - Time to first event of adjudicated CV (Cardiovascular) death or adjudicated HHF (Hospitalisation for Heart Failure) in patients with Heart Failure with preserved Ejection Fraction (HFpEF)
- Occurrence of adjudicated HHF (Hospitalisation for Heart Failure) (first and recurrent)
- eGFR (Estimated Glomerular Filtration Rate) (CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Equation))cr slope of change from baseline
- (and 7 more...)
|
6000 |
All |
18 Years and older (Adult, Older Adult) |
NCT03057951 |
1245.110 2016-002278-11 |
|
March 2, 2017 |
June 1, 2021 |
June 1, 2021 |
February 20, 2017 |
February 5, 2019 |
|
- Pinnacle Research Group, LLC
Anniston, Alabama, United States - Heart Center Research, LLC
Huntsville, Alabama, United States - University of California San Francisco
Fresno, California, United States - (and 570 more...)
|
|
5 |
NCT01167881 |
Completed Has Results |
Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes |
- Diabetes Mellitus, Type 2
|
- Drug: BI 10773
- Drug: Glimepiride
- Drug: Placebo
|
Interventional
|
Phase 3 |
- Boehringer Ingelheim
- Eli Lilly and Company
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment.
- The Change in Body Weight From Baseline After 104 Weeks of Treatment.
- The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment.
- (and 7 more...)
|
1549 |
All |
18 Years and older (Adult, Older Adult) |
NCT01167881 |
1245.28 2009-016244-39 |
|
August 2010 |
August 2013 |
August 2015 |
July 22, 2010 |
September 2, 2016 |
August 8, 2014 |
- 1245.28.10005 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States - 1245.28.10012 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States - 1245.28.10016 Boehringer Ingelheim Investigational Site
Hot Springs, Arkansas, United States - (and 179 more...)
|
|
6 |
NCT03429543 |
Recruiting |
Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents (DINAMO)TM |
- Diabetes Mellitus, Type 2
|
- Drug: Linagliptin
- Drug: Empagliflozin
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change from baseline in HbA1c (%)
- Change from baseline in fasting plasma glucose (mg/dl)
- Change from baseline in body weight (kg)
- (and 2 more...)
|
138 |
All |
10 Years to 17 Years (Child) |
NCT03429543 |
1218-0091 2016-000669-21 |
|
March 20, 2018 |
July 5, 2021 |
January 31, 2022 |
February 12, 2018 |
February 5, 2019 |
|
- Providence Alaska Medical Center
Anchorage, Alaska, United States - Phoenix Children's Hospital
Phoenix, Arizona, United States - University of Arizona
Tucson, Arizona, United States - (and 62 more...)
|
|
7 |
NCT01159600 |
Completed Has Results |
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 |
- Diabetes Mellitus, Type 2
|
- Drug: Placebo identical to BI 10773 high dose
- Drug: Placebo identical to BI 10773 low dose
- Drug: BI 10773
|
Interventional
|
Phase 3 |
- Boehringer Ingelheim
- Eli Lilly and Company
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- HbA1c Change From Baseline
- Body Weight Change From Baseline
- Mean Daily Plasma Glucose (MDG) Change From Baseline
|
1504 |
All |
18 Years and older (Adult, Older Adult) |
NCT01159600 |
1245.23 2009-016258-41 |
|
July 2010 |
February 2012 |
|
July 9, 2010 |
June 17, 2014 |
June 17, 2014 |
- 1245.23.10145 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States - 1245.23.10046 Boehringer Ingelheim Investigational Site
Tempe, Arizona, United States - 1245.23.10095 Boehringer Ingelheim Investigational Site
Huntington Park, California, United States - (and 145 more...)
|
|
8 |
NCT01422876 |
Completed Has Results |
Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients |
- Diabetes Mellitus, Type 2
|
- Drug: high dose FDC
- Drug: BI 10773 high dose
- Drug: high dose FDC placebo
- (and 8 more...)
|
Interventional
|
Phase 3 |
- Boehringer Ingelheim
- Eli Lilly and Company
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Metformin Background Patients
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Treatment Naive Patients
- Change From Baseline in Fasting Plasma Glucose at Week 24 for Metformin Background Patients
- (and 5 more...)
|
1405 |
All |
18 Years and older (Adult, Older Adult) |
NCT01422876 |
1275.1 2011-000383-10 |
|
August 2011 |
September 2013 |
September 2013 |
August 25, 2011 |
April 2, 2015 |
April 2, 2015 |
- 1275.1.01103 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States - 1275.1.01107 Boehringer Ingelheim Investigational Site
Foley, Alabama, United States - 1275.1.01043 Boehringer Ingelheim Investigational Site
Mobile, Alabama, United States - (and 208 more...)
|
|
9 |
NCT01289990 |
Completed Has Results |
Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes |
- Diabetes Mellitus, Type 2
|
- Drug: BI 10773
- Drug: Placebo
- Drug: Sitagliptin 100mg
|
Interventional
|
Phase 3 |
- Boehringer Ingelheim
- Eli Lilly and Company
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment
- Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment
- HbA1c (%) Changes From Baseline After 76 Weeks of Treatment
- (and 10 more...)
|
2705 |
All |
18 Years and older (Adult, Older Adult) |
NCT01289990 |
1245.31 2010-022718-17 |
|
February 2011 |
May 2013 |
May 2013 |
February 4, 2011 |
July 15, 2014 |
July 15, 2014 |
- 1245.31.10145 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States - 1245.31.10162 Boehringer Ingelheim Investigational Site
Glendale, Arizona, United States - 1245.31.10124 Boehringer Ingelheim Investigational Site
Mesa, Arizona, United States - (and 240 more...)
|
|
10 |
NCT02580591 |
Completed Has Results |
Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With T1DM (EASE-3) |
- Diabetes Mellitus, Type 1
|
- Drug: Empagliflozin
- Drug: Placebo
|
Interventional
|
Phase 3 |
- Boehringer Ingelheim
- Eli Lilly and Company
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Full Analysis Set (FAS) (Observed Cases [OC])
- Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Modified Intention-to-treat Population Set (mITT) (Observed Case (OC) - All Data (AD) (OC-AD))
- Rate Per Patient-year of Investigator-reported Symptomatic Hypoglycemic Adverse Events (AEs) With Confirmed Plasma Glucose (PG)
- (and 3 more...)
|
977 |
All |
18 Years and older (Adult, Older Adult) |
NCT02580591 |
1245.72 2014-005256-26 |
|
December 22, 2015 |
September 12, 2017 |
September 20, 2017 |
October 20, 2015 |
November 2, 2018 |
November 2, 2018 |
- Healthscan Clinical Trials LLC
Montgomery, Alabama, United States - John Muir Physician Network Clinical Research Center
Concord, California, United States - Valley Research
Fresno, California, United States - (and 186 more...)
|
|
11 |
NCT01649297 |
Completed Has Results |
A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy |
- Diabetes Mellitus, Type 2
|
- Drug: Placebo
- Drug: empagliflozin (low dose qd)
- Drug: Empagliflozin (high dose qd)
- (and 2 more...)
|
Interventional
|
Phase 2 |
- Boehringer Ingelheim
- Eli Lilly and Company
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16
- Fasting Plasma Glucose (FPG) Change From Baseline at Week 16
|
983 |
All |
18 Years and older (Adult, Older Adult) |
NCT01649297 |
1276.10 2012-000905-53 |
|
October 2012 |
December 2013 |
December 2013 |
July 25, 2012 |
July 23, 2015 |
July 23, 2015 |
- 1276.10.11036 Boehringer Ingelheim Investigational Site
Florence, Alabama, United States - 1276.10.11049 Boehringer Ingelheim Investigational Site
Jonesboro, Arkansas, United States - 1276.10.11040 Boehringer Ingelheim Investigational Site
Lomita, California, United States - (and 136 more...)
|
|
12 |
NCT03351478 |
Active, not recruiting |
Efficacy and Safety of Sotagliflozin Versus Placebo and Empagliflozin in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking a DPP4 Inhibitor Alone or With Metformin |
|
- Drug: Sotagliflozin (SAR439954)
- Drug: Empagliflozin
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change in HbA1c
- Change in sitting SBP in patients with SBP ≥130 mmHg at Baseline
- Change in 2-hour PPG following a MMTT
- (and 5 more...)
|
700 |
All |
18 Years and older (Adult, Older Adult) |
NCT03351478 |
EFC14867 2016-001803-22 U1111-1190-7607 |
SOTA-EMPA |
November 27, 2017 |
May 2019 |
May 2019 |
November 22, 2017 |
November 12, 2018 |
|
- Investigational Site Number 8408035
Birmingham, Alabama, United States - Investigational Site Number 8408050
Birmingham, Alabama, United States - Investigational Site Number 8408028
Sheffield, Alabama, United States - (and 171 more...)
|
|
13 |
NCT01719003 |
Completed Has Results |
Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes |
- Diabetes Mellitus, Type 2
- Hyperglycemia
|
- Drug: Metformin 500 mg bid
- Drug: Metformin 1000 mg bid
- Drug: Empagliflozin low dose qd
- (and 3 more...)
|
Interventional
|
Phase 3 |
- Boehringer Ingelheim
- Eli Lilly and Company
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24
- FPG (Fasting Plasma Glucose) Change From Baseline at Week 24
- Body Weight Change From Baseline at Week 24
|
1413 |
All |
18 Years and older (Adult, Older Adult) |
NCT01719003 |
1276.1 2010-021375-92 |
|
October 2012 |
November 2014 |
December 2014 |
November 1, 2012 |
February 19, 2016 |
February 19, 2016 |
- 1276.1.10014 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States - 1276.1.10019 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States - 1276.1.10044 Boehringer Ingelheim Investigational Site
Hot Springs, Alaska, United States - (and 187 more...)
|
|
14 |
NCT03152552 |
Completed |
A Dose Finding Study to Assess the Effect of LIK066 Compared to Placebo or Empagliflozin in Patients With Type 2 Diabetes Mellitus and Heart Failure |
|
- Drug: LIK066
- Drug: Placebo
- Drug: Empagliflozin
|
Interventional
|
Phase 2 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Change from Baseline in N-terminal pro b-type natriuretic peptide (NT-proBNP) at Week 12
- Change from Baseline in glycated hemoglobin (HbA1c) at Weeks 12 and 36
- Change from Baseline in Fasting Plasma Glucose (FPG) at Weeks 12 and 36
- (and 15 more...)
|
125 |
All |
18 Years and older (Adult, Older Adult) |
NCT03152552 |
CLIK066B2204 2016-003084-19 |
|
July 25, 2017 |
June 6, 2018 |
June 6, 2018 |
May 15, 2017 |
January 18, 2019 |
|
- Novartis Investigative Site
Huntsville, Alabama, United States - Novartis Investigative Site
Carmichael, California, United States - Novartis Investigative Site
Concord, California, United States - (and 103 more...)
|
|
15 |
NCT02121483 |
Completed Has Results |
Pharmacokinetic Single Dose Trial of Empagliflozin in Children and Adolescents With Type 2 Diabetes Mellitus |
- Diabetes Mellitus, Type 2
|
- Drug: empagliflozin medium dose
- Drug: empagliflozin high dose
- Drug: empagliflozin low dose
|
Interventional
|
Phase 1 |
- Boehringer Ingelheim
- Eli Lilly and Company
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- AUC0-inf
- AUC0-tz
- Cmax
- (and 5 more...)
|
27 |
All |
10 Years to 17 Years (Child) |
NCT02121483 |
1245.87 2013-002304-14 |
|
June 2014 |
February 2016 |
February 2016 |
April 23, 2014 |
September 19, 2016 |
September 19, 2016 |
- 1245.87.01013 Boehringer Ingelheim Investigational Site
New Haven, Connecticut, United States - 1245.87.01004 Boehringer Ingelheim Investigational Site
Boston, Massachusetts, United States - 1245.87.01002 Boehringer Ingelheim Investigational Site
Toledo, Ohio, United States - (and 8 more...)
|
|
16 |
NCT02597049 |
Completed Has Results |
A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus |
|
- Drug: Dulaglutide
- Drug: Placebo
- Drug: SGLT2 inhibitor
- Drug: Metformin
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change From Baseline in Hemoglobin A1c (HbA1c) at 24 Weeks (Treatment-regimen Estimand)
- Change From Baseline in the HbA1c at 24 Weeks (Efficacy Estimand)
- Percentage of Participants With HbA1c <7%
- (and 8 more...)
|
424 |
All |
18 Years and older (Adult, Older Adult) |
NCT02597049 |
15361 H9X-MC-GBGE 2015-002095-24 |
AWARD-10 |
November 2015 |
February 2017 |
February 2017 |
November 4, 2015 |
April 27, 2018 |
April 27, 2018 |
- Medical Group of Encino
Encino, California, United States - National Research Institute
Huntington Park, California, United States - National Research Institute
Los Angeles, California, United States - (and 38 more...)
|
|