Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01167881

Recruitment Status : Completed

First Posted : July 22, 2010

Results First Posted : August 8, 2014

Last Update Posted : September 2, 2016

Sponsor:

Collaborator:

Eli Lilly and Company

Information provided by (Responsible Party):

Boehringer Ingelheim

Study Description

Brief Summary:

This is a pivotal phase III study, mandatory to seek approval by regulatory authorities for BI 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2 diabetes mellitus and insufficient glycaemic control.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 2	Drug: BI 10773 Drug: Glimepiride Drug: Placebo	Phase 3

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1549 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	A Phase III Randomised, Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 10773 Compared to Glimepiride Administered Orally During 104 Weeks With a 104 Week Extension Period in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Metformin Treatment
Study Start Date :	August 2010
Actual Primary Completion Date :	August 2013
Actual Study Completion Date :	August 2015

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Type 2 diabetes

Drug Information available for: Metformin Metformin hydrochloride Glimepiride Empagliflozin

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: BI 10773 dose plus metformin Patients receive one BI10773 tablet and one placebo Glimepiride capsule once daily	Drug: BI 10773 Medium dose once daily Drug: Placebo Placebo matching Glimepiride
Active Comparator: Glimepiride 1-4 mg plus metformin Patients receive one glimepiride capsule and one placebo tablet Bi 10773 once daily.	Drug: Glimepiride 1-4 mg once daily Drug: Placebo Placebo matching BI 10773

Outcome Measures

Primary Outcome Measures :

The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment. [ Time Frame: Baseline and 104 weeks ]

Secondary Outcome Measures :

The Change in Body Weight From Baseline After 104 Weeks of Treatment. [ Time Frame: baseline and 104 weeks ]
The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment. [ Time Frame: baseline and 104 weeks ]
The Change in Systolic Blood Pressure (SBP) From Baseline After 104 Weeks of Treatment. [ Time Frame: baseline and 104 weeks ]
The Change in Diastolic Blood Pressure (DBP) From Baseline After 104 Weeks of Treatment. [ Time Frame: baseline and 104 weeks ]
The Change From Baseline in HbA1c After 52 Weeks of Treatment. [ Time Frame: baseline and 52 weeks ]
The Change in Body Weight From Baseline After 52 Weeks of Treatment. [ Time Frame: baseline and 52 weeks ]
The Occurrence of Confirmed Hypoglycaemic Events During 52 Weeks of Treatment. [ Time Frame: baseline and 52 weeks ]
The Change in Systolic Blood Pressure (SBP) From Baseline After 52 Weeks of Treatment. [ Time Frame: baseline and 52 weeks ]
The Change in Diastolic Blood Pressure (DBP) From Baseline After 52 Weeks of Treatment. [ Time Frame: baseline and 52 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Diagnosis typ 2 diabetes mellitus
Male and female on diet and exercise regimen, pre-treated with metformin 12 weeks prior to randomisation
HbA1c equal or greater than 7.0% and less than or equal to 10% at visit 1
18 years or more
BMI equal or less than 45Kg/m2

Exclusion criteria:

Uncontrolled hyperglycemia defined as glucose more that 13.3 mmol/L after overnight fast during placebo run-in
Any other antidiabetic drug within 12 weeks prior to randomisation except metformin
Acute coronary syndrome (non-STEMI, STEMI unstable angina pectoris), stroke or transient ischemic attack within 12 weeks of informed consent
Indication of liver disease
Moderate to severe renal impairment
Bariatric surgery within past 2 years
Medical history of cancer or treatment for cancer within last 5 years
Blood dyscrasias or any disorders causing haemolysis or unstable red blood cell
Contraindications hypersensitivity to concomitant drugs
Treatment with anti-obesity drugs

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01167881

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Locations


United States, Arizona
1245.28.10005 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
1245.28.10012 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
United States, Arkansas
1245.28.10016 Boehringer Ingelheim Investigational Site
Hot Springs, Arkansas, United States
United States, California
1245.28.10003 Boehringer Ingelheim Investigational Site
Sacramento, California, United States
1245.28.10021 Boehringer Ingelheim Investigational Site
West Hills, California, United States
United States, Florida
1245.28.10009 Boehringer Ingelheim Investigational Site
Bradednton, Florida, United States
1245.28.10015 Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
United States, Georgia
1245.28.10033 Boehringer Ingelheim Investigational Site
Blue Ridge, Georgia, United States
United States, Idaho
1245.28.10026 Boehringer Ingelheim Investigational Site
Boise, Idaho, United States
United States, Nebraska
1245.28.10007 Boehringer Ingelheim Investigational Site
Omaha, Nebraska, United States
United States, Nevada
1245.28.10027 Boehringer Ingelheim Investigational Site
Henderson, Nevada, United States
United States, New York
1245.28.10014 Boehringer Ingelheim Investigational Site
Rochester, New York, United States
United States, North Carolina
1245.28.10006 Boehringer Ingelheim Investigational Site
Shelby, North Carolina, United States
United States, Ohio
1245.28.10011 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
1245.28.10019 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
1245.28.10004 Boehringer Ingelheim Investigational Site
Columbus, Ohio, United States
1245.28.10008 Boehringer Ingelheim Investigational Site
Perrysburg, Ohio, United States
United States, Oregon
1245.28.10020 Boehringer Ingelheim Investigational Site
Medford, Oregon, United States
1245.28.10017 Boehringer Ingelheim Investigational Site
Portland, Oregon, United States
United States, Texas
1245.28.10031 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
1245.28.10032 Boehringer Ingelheim Investigational Site
Longview, Texas, United States
1245.28.10022 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
United States, Utah
1245.28.10030 Boehringer Ingelheim Investigational Site
Draper, Utah, United States
1245.28.10023 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah, United States
United States, Wisconsin
1245.28.10013 Boehringer Ingelheim Investigational Site
Kenosha, Wisconsin, United States
Argentina
1245.28.54010 Boehringer Ingelheim Investigational Site
Buenos Aires, Argentina
1245.28.54001 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1245.28.54002 Boehringer Ingelheim Investigational Site
Córdoba, Argentina
1245.28.54003 Boehringer Ingelheim Investigational Site
Córdoba, Argentina
Austria
1245.28.43006 Boehringer Ingelheim Investigational Site
Graz, Austria
1245.28.43005 Boehringer Ingelheim Investigational Site
Salzburg, Austria
1245.28.43001 Boehringer Ingelheim Investigational Site
Wien, Austria
1245.28.43002 Boehringer Ingelheim Investigational Site
Wien, Austria
1245.28.43003 Boehringer Ingelheim Investigational Site
Wien, Austria
1245.28.43004 Boehringer Ingelheim Investigational Site
Wien, Austria
Canada, Alberta
1245.28.20074 Boehringer Ingelheim Investigational Site
Calgary, Alberta, Canada
1245.28.20077 Boehringer Ingelheim Investigational Site
Calgary, Alberta, Canada
1245.28.20075 Boehringer Ingelheim Investigational Site
Edmonton, Alberta, Canada
Canada, British Columbia
1245.28.20084 Boehringer Ingelheim Investigational Site
Langley, British Columbia, Canada
Canada, Newfoundland and Labrador
1245.28.20082 Boehringer Ingelheim Investigational Site
Grand Falls-Windsor, Newfoundland and Labrador, Canada
1245.28.20016 Boehringer Ingelheim Investigational Site
Mount Pearl, Newfoundland and Labrador, Canada
1245.28.20079 Boehringer Ingelheim Investigational Site
St. John's, Newfoundland and Labrador, Canada
Canada, Nova Scotia
1245.28.20071 Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia, Canada
Canada, Ontario
1245.28.20080 Boehringer Ingelheim Investigational Site
Collingwood, Ontario, Canada
1245.28.20078 Boehringer Ingelheim Investigational Site
Stayner, Ontario, Canada
1245.28.20005 Boehringer Ingelheim Investigational Site
Strathroy, Ontario, Canada
1245.28.20083 Boehringer Ingelheim Investigational Site
Sudbury, Ontario, Canada
Canada, Quebec
1245.28.20072 Boehringer Ingelheim Investigational Site
Chicoutimi, Quebec, Canada
1245.28.20081 Boehringer Ingelheim Investigational Site
Chicoutimi, Quebec, Canada
1245.28.20085 Boehringer Ingelheim Investigational Site
Gatineau, Quebec, Canada
1245.28.20043 Boehringer Ingelheim Investigational Site
Longueuil, Quebec, Canada
1245.28.20070 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
1245.28.20073 Boehringer Ingelheim Investigational Site
Sherbrooke, Quebec, Canada
1245.28.20021 Boehringer Ingelheim Investigational Site
Trois Rivieres, Quebec, Canada
Canada
1245.28.20076 Boehringer Ingelheim Investigational Site
Quebec, Canada
Colombia
1245.28.57007 Boehringer Ingelheim Investigational Site
Barranquilla, Colombia
1245.28.57005 Boehringer Ingelheim Investigational Site
Bogota, Colombia
1245.28.57003 Boehringer Ingelheim Investigational Site
Bogotá, Colombia
1245.28.57006 Boehringer Ingelheim Investigational Site
Floridablanca, Colombia
Czech Republic
1245.28.42003 Boehringer Ingelheim Investigational Site
Brno, Czech Republic
1245.28.42005 Boehringer Ingelheim Investigational Site
Holice, Czech Republic
1245.28.42002 Boehringer Ingelheim Investigational Site
Mlada Boleslav, Czech Republic
1245.28.42008 Boehringer Ingelheim Investigational Site
Praha 1, Czech Republic
1245.28.42001 Boehringer Ingelheim Investigational Site
Slany, Czech Republic
1245.28.42007 Boehringer Ingelheim Investigational Site
Slany, Czech Republic
1245.28.42004 Boehringer Ingelheim Investigational Site
Uherske Hradiste, Czech Republic
1245.28.42006 Boehringer Ingelheim Investigational Site
Zlin, Czech Republic
Finland
1245.28.72001 Boehringer Ingelheim Investigational Site
Helsinki, Finland
1245.28.72004 Boehringer Ingelheim Investigational Site
Joensuu, Finland
1245.28.72003 Boehringer Ingelheim Investigational Site
Oulu, Finland
1245.28.72002 Boehringer Ingelheim Investigational Site
Pori, Finland
Hong Kong
1245.28.85201 Boehringer Ingelheim Investigational Site
Hong Kong, Hong Kong
1245.28.85207 Boehringer Ingelheim Investigational Site
Hong Kong, Hong Kong
1245.28.85202 Boehringer Ingelheim Investigational Site
Kowloon, Hong Kong
India
1245.28.91206 Boehringer Ingelheim Investigational Site
Ahmedabad, India
1245.28.91202 Boehringer Ingelheim Investigational Site
Bangalore, India
1245.28.91204 Boehringer Ingelheim Investigational Site
Bangalore, India
1245.28.91205 Boehringer Ingelheim Investigational Site
Bangalore, India
1245.28.91208 Boehringer Ingelheim Investigational Site
Bangalore, India
1245.28.91201 Boehringer Ingelheim Investigational Site
Chennai, India
1245.28.91213 Boehringer Ingelheim Investigational Site
Chennai, India
1245.28.91203 Boehringer Ingelheim Investigational Site
Hyderabad, India
1245.28.91211 Boehringer Ingelheim Investigational Site
Kolkata, India
1245.28.91210 Boehringer Ingelheim Investigational Site
Mangalore, India
1245.28.91212 Boehringer Ingelheim Investigational Site
New Delhi, India
1245.28.91207 Boehringer Ingelheim Investigational Site
Pune, India
1245.28.91209 Boehringer Ingelheim Investigational Site
Uttar Pradesh, India
Italy
1245.28.39021 Boehringer Ingelheim Investigational Site
Cagliari, Italy
1245.28.39022 Boehringer Ingelheim Investigational Site
Chieri (to), Italy
1245.28.39016 Boehringer Ingelheim Investigational Site
Lucca, Italy
1245.28.39018 Boehringer Ingelheim Investigational Site
Milano, Italy
1245.28.39019 Boehringer Ingelheim Investigational Site
Milano, Italy
1245.28.39017 Boehringer Ingelheim Investigational Site
Monserrato (ca), Italy
1245.28.39023 Boehringer Ingelheim Investigational Site
Rimini, Italy
1245.28.39020 Boehringer Ingelheim Investigational Site
Salerno, Italy
Malaysia
1245.28.60003 Boehringer Ingelheim Investigational Site
Johor Bahru, Malaysia
1245.28.60006 Boehringer Ingelheim Investigational Site
Kelantan, Malaysia
1245.28.60005 Boehringer Ingelheim Investigational Site
Kuala Lumpur, Malaysia
1245.28.60009 Boehringer Ingelheim Investigational Site
Kuala Lumpur, Malaysia
1245.28.60004 Boehringer Ingelheim Investigational Site
Pahang, Malaysia
1245.28.60007 Boehringer Ingelheim Investigational Site
Perak, Malaysia
1245.28.60010 Boehringer Ingelheim Investigational Site
Pulau Pinang, Malaysia
1245.28.60001 Boehringer Ingelheim Investigational Site
Selangor Darul Ehsan, Malaysia
Mexico
1245.28.52006 Boehringer Ingelheim Investigational Site
Aguascalientes, Mexico
1245.28.52008 Boehringer Ingelheim Investigational Site
Cuautla, Mexico
1245.28.52009 Boehringer Ingelheim Investigational Site
Guadalajara, Mexico
1245.28.52007 Boehringer Ingelheim Investigational Site
Mexico, Mexico
Netherlands
1245.28.31008 Boehringer Ingelheim Investigational Site
's HERTOGENBOSCH, Netherlands
1245.28.31020 Boehringer Ingelheim Investigational Site
Losser, Netherlands
1245.28.31014 Boehringer Ingelheim Investigational Site
Rotterdam, Netherlands
Norway
1245.28.47002 Boehringer Ingelheim Investigational Site
Hønefoss, Norway
1245.28.47001 Boehringer Ingelheim Investigational Site
Oslo, Norway
1245.28.47003 Boehringer Ingelheim Investigational Site
Sandefjord, Norway
Philippines
1245.28.63016 Boehringer Ingelheim Investigational Site
Cavite City, Philippines
1245.28.63013 Boehringer Ingelheim Investigational Site
Cebu City, Philippines
1245.28.63020 Boehringer Ingelheim Investigational Site
Jaro Iloilo City, Philippines
1245.28.63004 Boehringer Ingelheim Investigational Site
Manila, Philippines
1245.28.63015 Boehringer Ingelheim Investigational Site
Manila, Philippines
1245.28.63012 Boehringer Ingelheim Investigational Site
Pasig City, Philippines
1245.28.63011 Boehringer Ingelheim Investigational Site
Quezon City, Philippines
1245.28.63010 Boehringer Ingelheim Investigational Site
Tacloban, Philippines
1245.28.63014 Boehringer Ingelheim Investigational Site
Tagbilaran City, Bohol, Philippines
Portugal
1245.28.35006 Boehringer Ingelheim Investigational Site
Amadora, Portugal
1245.28.35002 Boehringer Ingelheim Investigational Site
Lisboa, Portugal
1245.28.35012 Boehringer Ingelheim Investigational Site
Porto, Portugal
1245.28.35016 Boehringer Ingelheim Investigational Site
Vila Nova de Gaia, Portugal
South Africa
1245.28.76019 Boehringer Ingelheim Investigational Site
Boksburg North, South Africa
1245.28.76018 Boehringer Ingelheim Investigational Site
Bryanston, South Africa
1245.28.76016 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
1245.28.76017 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
1245.28.76012 Boehringer Ingelheim Investigational Site
Durban, South Africa
1245.28.76015 Boehringer Ingelheim Investigational Site
Durban, South Africa
1245.28.76013 Boehringer Ingelheim Investigational Site
Krugersdorp, South Africa
1245.28.76023 Boehringer Ingelheim Investigational Site
Lenasia South, South Africa
1245.28.76024 Boehringer Ingelheim Investigational Site
Lenasia, South Africa
1245.28.76014 Boehringer Ingelheim Investigational Site
Pretoria, South Africa
Spain
1245.28.34004 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1245.28.34011 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1245.28.34002 Boehringer Ingelheim Investigational Site
Burjasot, Spain
1245.28.34003 Boehringer Ingelheim Investigational Site
Centelles, Spain
1245.28.34009 Boehringer Ingelheim Investigational Site
Granada, Spain
1245.28.34012 Boehringer Ingelheim Investigational Site
Madrid, Spain
1245.28.34013 Boehringer Ingelheim Investigational Site
Madrid, Spain
1245.28.34005 Boehringer Ingelheim Investigational Site
Mataró, Spain
1245.28.34001 Boehringer Ingelheim Investigational Site
Pineda de Mar, Spain
1245.28.34010 Boehringer Ingelheim Investigational Site
San Sebastian de los Reyes, Spain
1245.28.34006 Boehringer Ingelheim Investigational Site
Tarrega - Lleida, Spain
Sweden
1245.28.46009 Boehringer Ingelheim Investigational Site
Borås, Sweden
1245.28.46008 Boehringer Ingelheim Investigational Site
Lund, Sweden
1245.28.46001 Boehringer Ingelheim Investigational Site
Malmö, Sweden
1245.28.46002 Boehringer Ingelheim Investigational Site
Stockholm, Sweden
1245.28.46006 Boehringer Ingelheim Investigational Site
Stockholm, Sweden
1245.28.46007 Boehringer Ingelheim Investigational Site
Stockholm, Sweden
1245.28.46004 Boehringer Ingelheim Investigational Site
Uppsala, Sweden
1245.28.46005 Boehringer Ingelheim Investigational Site
Örebro, Sweden
Switzerland
1245.28.41015 Boehringer Ingelheim Investigational Site
Ascona, Switzerland
1245.28.41017 Inselspital Bern
Bern, Switzerland
Taiwan
1245.28.88004 Boehringer Ingelheim Investigational Site
Changhua, Taiwan
1245.28.88003 Boehringer Ingelheim Investigational Site
Taichung, Taiwan
1245.28.88005 Boehringer Ingelheim Investigational Site
Tainan Hsien, Taiwan
1245.28.88002 Boehringer Ingelheim Investigational Site
Taipei Hsien, Taiwan
1245.28.88001 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
Thailand
1245.28.66006 Boehringer Ingelheim Investigational Site
Bangkok, Thailand
1245.28.66007 Boehringer Ingelheim Investigational Site
Bangkok, Thailand
1245.28.66004 Boehringer Ingelheim Investigational Site
Muang District, Thailand
1245.28.66008 Boehringer Ingelheim Investigational Site
Nakhonratchasima, Thailand
United Kingdom
1245.28.44006 Boehringer Ingelheim Investigational Site
Addlestone, United Kingdom
1245.28.44020 Boehringer Ingelheim Investigational Site
Ashford, United Kingdom
1245.28.44008 Boehringer Ingelheim Investigational Site
Balham, United Kingdom
1245.28.44035 Boehringer Ingelheim Investigational Site
Barnstable, United Kingdom
1245.28.44016 Boehringer Ingelheim Investigational Site
Blackpool, United Kingdom
1245.28.44021 Boehringer Ingelheim Investigational Site
Bradford on Avon, United Kingdom
1245.28.44019 Boehringer Ingelheim Investigational Site
Burbage, United Kingdom
1245.28.44027 Boehringer Ingelheim Investigational Site
Chestfield, Whitstable, United Kingdom
1245.28.44011 Boehringer Ingelheim Investigational Site
Chippenham, United Kingdom
1245.28.44022 Boehringer Ingelheim Investigational Site
Chippenham, United Kingdom
1245.28.44043 Boehringer Ingelheim Investigational Site
Coventry, United Kingdom
1245.28.44025 Boehringer Ingelheim Investigational Site
Doncaster, United Kingdom
1245.28.44030 Boehringer Ingelheim Investigational Site
Ely, United Kingdom
1245.28.44007 Boehringer Ingelheim Investigational Site
Midsomer Norton, United Kingdom
1245.28.44023 Boehringer Ingelheim Investigational Site
Nantwich, United Kingdom
1245.28.44017 Boehringer Ingelheim Investigational Site
Whitstable, United Kingdom

Sponsors and Collaborators

Boehringer Ingelheim

Eli Lilly and Company

Investigators


Study Chair:	Boehringer Ingelheim	Boehringer Ingelheim

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ridderstråle M, Andersen KR, Zeller C, Kim G, Woerle HJ, Broedl UC; EMPA-REG H2H-SU trial investigators. Comparison of empagliflozin and glimepiride as add-on to metformin in patients with type 2 diabetes: a 104-week randomised, active-controlled, double-blind, phase 3 trial. Lancet Diabetes Endocrinol. 2014 Sep;2(9):691-700. doi: 10.1016/S2213-8587(14)70120-2. Epub 2014 Jun 16. Erratum in: Lancet Diabetes Endocrinol. 2015 Sept;3(9):e7.

Ridderstråle M, Svaerd R, Zeller C, Kim G, Woerle HJ, Broedl UC; EMPA-REG H2H-SU trial investigators. Rationale, design and baseline characteristics of a 4-year (208-week) phase III trial of empagliflozin, an SGLT2 inhibitor, versus glimepiride as add-on to metformin in patients with type 2 diabetes mellitus with insufficient glycemic control. Cardiovasc Diabetol. 2013 Sep 5;12:129. doi: 10.1186/1475-2840-12-129.


Responsible Party:	Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT01167881 History of Changes
Other Study ID Numbers:	1245.28 2009-016244-39 ( EudraCT Number: EudraCT )
First Posted:	July 22, 2010 Key Record Dates
Results First Posted:	August 8, 2014
Last Update Posted:	September 2, 2016
Last Verified:	July 2016

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Glimepiride Empagliflozin	Metformin Hypoglycemic Agents Physiological Effects of Drugs Anti-Arrhythmia Agents Immunosuppressive Agents Immunologic Factors

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