Clinical trial NCT01167881: Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2010-07-22
Enrollment: 1549
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment.
timeFrame: Baseline and 104 weeks
Secondary outcomes:
measure: The Change in Body Weight From Baseline After 104 Weeks of Treatment.
timeFrame: baseline and 104 weeks
measure: The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment.
timeFrame: baseline and 104 weeks
measure: The Change in Systolic Blood Pressure (SBP) From Baseline After 104 Weeks of Treatment.
timeFrame: baseline and 104 weeks
measure: The Change in Diastolic Blood Pressure (DBP) From Baseline After 104 Weeks of Treatment.
timeFrame: baseline and 104 weeks
measure: The Change From Baseline in HbA1c After 52 Weeks of Treatment.
timeFrame: baseline and 52 weeks
measure: The Change in Body Weight From Baseline After 52 Weeks of Treatment.
timeFrame: baseline and 52 weeks
measure: The Occurrence of Confirmed Hypoglycaemic Events During 52 Weeks of Treatment.
timeFrame: baseline and 52 weeks
measure: The Change in Systolic Blood Pressure (SBP) From Baseline After 52 Weeks of Treatment.
timeFrame: baseline and 52 weeks
measure: The Change in Diastolic Blood Pressure (DBP) From Baseline After 52 Weeks of Treatment.
timeFrame: baseline and 52 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: 1245.28.10005 Boehringer Ingelheim Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: 1245.28.10012 Boehringer Ingelheim Investigational Site
state: Arizona
city: Hot Springs
country: United States
facility: 1245.28.10016 Boehringer Ingelheim Investigational Site
state: Arkansas
city: Sacramento
country: United States
facility: 1245.28.10003 Boehringer Ingelheim Investigational Site
state: California
city: West Hills
country: United States
facility: 1245.28.10021 Boehringer Ingelheim Investigational Site
state: California
city: Bradednton
country: United States
facility: 1245.28.10009 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 1245.28.10015 Boehringer Ingelheim Investigational Site
state: Florida
city: Blue Ridge
country: United States
facility: 1245.28.10033 Boehringer Ingelheim Investigational Site
state: Georgia
city: Boise
country: United States
facility: 1245.28.10026 Boehringer Ingelheim Investigational Site
state: Idaho
city: Omaha
country: United States
facility: 1245.28.10007 Boehringer Ingelheim Investigational Site
state: Nebraska
city: Henderson
country: United States
facility: 1245.28.10027 Boehringer Ingelheim Investigational Site
state: Nevada
city: Rochester
country: United States
facility: 1245.28.10014 Boehringer Ingelheim Investigational Site
state: New York
city: Shelby
country: United States
facility: 1245.28.10006 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: 1245.28.10011 Boehringer Ingelheim Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: 1245.28.10019 Boehringer Ingelheim Investigational Site
state: Ohio
city: Columbus
country: United States
facility: 1245.28.10004 Boehringer Ingelheim Investigational Site
state: Ohio
city: Perrysburg
country: United States
facility: 1245.28.10008 Boehringer Ingelheim Investigational Site
state: Ohio
city: Medford
country: United States
facility: 1245.28.10020 Boehringer Ingelheim Investigational Site
state: Oregon
city: Portland
country: United States
facility: 1245.28.10017 Boehringer Ingelheim Investigational Site
state: Oregon
city: Dallas
country: United States
facility: 1245.28.10031 Boehringer Ingelheim Investigational Site
state: Texas
city: Longview
country: United States
facility: 1245.28.10032 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 1245.28.10022 Boehringer Ingelheim Investigational Site
state: Texas
city: Draper
country: United States
facility: 1245.28.10030 Boehringer Ingelheim Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: 1245.28.10023 Boehringer Ingelheim Investigational Site
state: Utah
city: Kenosha
country: United States
facility: 1245.28.10013 Boehringer Ingelheim Investigational Site
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: 1245.28.54010 Boehringer Ingelheim Investigational Site
city: Capital Federal
country: Argentina
facility: 1245.28.54001 Boehringer Ingelheim Investigational Site
city: Córdoba
country: Argentina
facility: 1245.28.54002 Boehringer Ingelheim Investigational Site
city: Córdoba
country: Argentina
facility: 1245.28.54003 Boehringer Ingelheim Investigational Site
city: Graz
country: Austria
facility: 1245.28.43006 Boehringer Ingelheim Investigational Site
city: Salzburg
country: Austria
facility: 1245.28.43005 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1245.28.43001 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1245.28.43002 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1245.28.43003 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1245.28.43004 Boehringer Ingelheim Investigational Site
city: Calgary
country: Canada
facility: 1245.28.20074 Boehringer Ingelheim Investigational Site
state: Alberta
city: Calgary
country: Canada
facility: 1245.28.20077 Boehringer Ingelheim Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: 1245.28.20075 Boehringer Ingelheim Investigational Site
state: Alberta
city: Langley
country: Canada
facility: 1245.28.20084 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Grand Falls-Windsor
country: Canada
facility: 1245.28.20082 Boehringer Ingelheim Investigational Site
state: Newfoundland and Labrador
city: Mount Pearl
country: Canada
facility: 1245.28.20016 Boehringer Ingelheim Investigational Site
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: 1245.28.20079 Boehringer Ingelheim Investigational Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: 1245.28.20071 Boehringer Ingelheim Investigational Site
state: Nova Scotia
city: Collingwood
country: Canada
facility: 1245.28.20080 Boehringer Ingelheim Investigational Site
state: Ontario
city: Stayner
country: Canada
facility: 1245.28.20078 Boehringer Ingelheim Investigational Site
state: Ontario
city: Strathroy
country: Canada
facility: 1245.28.20005 Boehringer Ingelheim Investigational Site
state: Ontario
city: Sudbury
country: Canada
facility: 1245.28.20083 Boehringer Ingelheim Investigational Site
state: Ontario
city: Chicoutimi
country: Canada
facility: 1245.28.20072 Boehringer Ingelheim Investigational Site
state: Quebec
city: Chicoutimi
country: Canada
facility: 1245.28.20081 Boehringer Ingelheim Investigational Site
state: Quebec
city: Gatineau
country: Canada
facility: 1245.28.20085 Boehringer Ingelheim Investigational Site
state: Quebec
city: Longueuil
country: Canada
facility: 1245.28.20043 Boehringer Ingelheim Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: 1245.28.20070 Boehringer Ingelheim Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: 1245.28.20073 Boehringer Ingelheim Investigational Site
state: Quebec
city: Trois Rivieres
country: Canada
facility: 1245.28.20021 Boehringer Ingelheim Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: 1245.28.20076 Boehringer Ingelheim Investigational Site
city: Barranquilla
country: Colombia
facility: 1245.28.57007 Boehringer Ingelheim Investigational Site
city: Bogota
country: Colombia
facility: 1245.28.57005 Boehringer Ingelheim Investigational Site
city: Bogotá
country: Colombia
facility: 1245.28.57003 Boehringer Ingelheim Investigational Site
city: Floridablanca
country: Colombia
facility: 1245.28.57006 Boehringer Ingelheim Investigational Site
city: Brno
country: Czech Republic
facility: 1245.28.42003 Boehringer Ingelheim Investigational Site
city: Holice
country: Czech Republic
facility: 1245.28.42005 Boehringer Ingelheim Investigational Site
city: Mlada Boleslav
country: Czech Republic
facility: 1245.28.42002 Boehringer Ingelheim Investigational Site
city: Praha 1
country: Czech Republic
facility: 1245.28.42008 Boehringer Ingelheim Investigational Site
city: Slany
country: Czech Republic
facility: 1245.28.42001 Boehringer Ingelheim Investigational Site
city: Slany
country: Czech Republic
facility: 1245.28.42007 Boehringer Ingelheim Investigational Site
city: Uherske Hradiste
country: Czech Republic
facility: 1245.28.42004 Boehringer Ingelheim Investigational Site
city: Zlin
country: Czech Republic
facility: 1245.28.42006 Boehringer Ingelheim Investigational Site
city: Helsinki
country: Finland
facility: 1245.28.72001 Boehringer Ingelheim Investigational Site
city: Joensuu
country: Finland
facility: 1245.28.72004 Boehringer Ingelheim Investigational Site
city: Oulu
country: Finland
facility: 1245.28.72003 Boehringer Ingelheim Investigational Site
city: Pori
country: Finland
facility: 1245.28.72002 Boehringer Ingelheim Investigational Site
city: Hong Kong
country: Hong Kong
facility: 1245.28.85201 Boehringer Ingelheim Investigational Site
city: Hong Kong
country: Hong Kong
facility: 1245.28.85207 Boehringer Ingelheim Investigational Site
city: Kowloon
country: Hong Kong
facility: 1245.28.85202 Boehringer Ingelheim Investigational Site
city: Ahmedabad
country: India
facility: 1245.28.91206 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 1245.28.91202 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 1245.28.91204 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 1245.28.91205 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 1245.28.91208 Boehringer Ingelheim Investigational Site
city: Chennai
country: India
facility: 1245.28.91201 Boehringer Ingelheim Investigational Site
city: Chennai
country: India
facility: 1245.28.91213 Boehringer Ingelheim Investigational Site
city: Hyderabad
country: India
facility: 1245.28.91203 Boehringer Ingelheim Investigational Site
city: Kolkata
country: India
facility: 1245.28.91211 Boehringer Ingelheim Investigational Site
city: Mangalore
country: India
facility: 1245.28.91210 Boehringer Ingelheim Investigational Site
city: New Delhi
country: India
facility: 1245.28.91212 Boehringer Ingelheim Investigational Site
city: Pune
country: India
facility: 1245.28.91207 Boehringer Ingelheim Investigational Site
city: Uttar Pradesh
country: India
facility: 1245.28.91209 Boehringer Ingelheim Investigational Site
city: Cagliari
country: Italy
facility: 1245.28.39021 Boehringer Ingelheim Investigational Site
city: Chieri (to)
country: Italy
facility: 1245.28.39022 Boehringer Ingelheim Investigational Site
city: Lucca
country: Italy
facility: 1245.28.39016 Boehringer Ingelheim Investigational Site
city: Milano
country: Italy
facility: 1245.28.39018 Boehringer Ingelheim Investigational Site
city: Milano
country: Italy
facility: 1245.28.39019 Boehringer Ingelheim Investigational Site
city: Monserrato (ca)
country: Italy
facility: 1245.28.39017 Boehringer Ingelheim Investigational Site
city: Rimini
country: Italy
facility: 1245.28.39023 Boehringer Ingelheim Investigational Site
city: Salerno
country: Italy
facility: 1245.28.39020 Boehringer Ingelheim Investigational Site
city: Johor Bahru
country: Malaysia
facility: 1245.28.60003 Boehringer Ingelheim Investigational Site
city: Kelantan
country: Malaysia
facility: 1245.28.60006 Boehringer Ingelheim Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: 1245.28.60005 Boehringer Ingelheim Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: 1245.28.60009 Boehringer Ingelheim Investigational Site
city: Pahang
country: Malaysia
facility: 1245.28.60004 Boehringer Ingelheim Investigational Site
city: Perak
country: Malaysia
facility: 1245.28.60007 Boehringer Ingelheim Investigational Site
city: Pulau Pinang
country: Malaysia
facility: 1245.28.60010 Boehringer Ingelheim Investigational Site
city: Selangor Darul Ehsan
country: Malaysia
facility: 1245.28.60001 Boehringer Ingelheim Investigational Site
city: Aguascalientes
country: Mexico
facility: 1245.28.52006 Boehringer Ingelheim Investigational Site
city: Cuautla
country: Mexico
facility: 1245.28.52008 Boehringer Ingelheim Investigational Site
city: Guadalajara
country: Mexico
facility: 1245.28.52009 Boehringer Ingelheim Investigational Site
city: Mexico
country: Mexico
facility: 1245.28.52007 Boehringer Ingelheim Investigational Site
city: 's HERTOGENBOSCH
country: Netherlands
facility: 1245.28.31008 Boehringer Ingelheim Investigational Site
city: Losser
country: Netherlands
facility: 1245.28.31020 Boehringer Ingelheim Investigational Site
city: Rotterdam
country: Netherlands
facility: 1245.28.31014 Boehringer Ingelheim Investigational Site
city: Hønefoss
country: Norway
facility: 1245.28.47002 Boehringer Ingelheim Investigational Site
city: Oslo
country: Norway
facility: 1245.28.47001 Boehringer Ingelheim Investigational Site
city: Sandefjord
country: Norway
facility: 1245.28.47003 Boehringer Ingelheim Investigational Site
city: Cavite City
country: Philippines
facility: 1245.28.63016 Boehringer Ingelheim Investigational Site
city: Cebu City
country: Philippines
facility: 1245.28.63013 Boehringer Ingelheim Investigational Site
city: Jaro Iloilo City
country: Philippines
facility: 1245.28.63020 Boehringer Ingelheim Investigational Site
city: Manila
country: Philippines
facility: 1245.28.63004 Boehringer Ingelheim Investigational Site
city: Manila
country: Philippines
facility: 1245.28.63015 Boehringer Ingelheim Investigational Site
city: Pasig City
country: Philippines
facility: 1245.28.63012 Boehringer Ingelheim Investigational Site
city: Quezon City
country: Philippines
facility: 1245.28.63011 Boehringer Ingelheim Investigational Site
city: Tacloban
country: Philippines
facility: 1245.28.63010 Boehringer Ingelheim Investigational Site
city: Tagbilaran City, Bohol
country: Philippines
facility: 1245.28.63014 Boehringer Ingelheim Investigational Site
city: Amadora
country: Portugal
facility: 1245.28.35006 Boehringer Ingelheim Investigational Site
city: Lisboa
country: Portugal
facility: 1245.28.35002 Boehringer Ingelheim Investigational Site
city: Porto
country: Portugal
facility: 1245.28.35012 Boehringer Ingelheim Investigational Site
city: Vila Nova de Gaia
country: Portugal
facility: 1245.28.35016 Boehringer Ingelheim Investigational Site
city: Boksburg North
country: South Africa
facility: 1245.28.76019 Boehringer Ingelheim Investigational Site
city: Bryanston
country: South Africa
facility: 1245.28.76018 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 1245.28.76016 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 1245.28.76017 Boehringer Ingelheim Investigational Site
city: Durban
country: South Africa
facility: 1245.28.76012 Boehringer Ingelheim Investigational Site
city: Durban
country: South Africa
facility: 1245.28.76015 Boehringer Ingelheim Investigational Site
city: Krugersdorp
country: South Africa
facility: 1245.28.76013 Boehringer Ingelheim Investigational Site
city: Lenasia South
country: South Africa
facility: 1245.28.76023 Boehringer Ingelheim Investigational Site
city: Lenasia
country: South Africa
facility: 1245.28.76024 Boehringer Ingelheim Investigational Site
city: Pretoria
country: South Africa
facility: 1245.28.76014 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1245.28.34004 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1245.28.34011 Boehringer Ingelheim Investigational Site
city: Burjasot
country: Spain
facility: 1245.28.34002 Boehringer Ingelheim Investigational Site
city: Centelles
country: Spain
facility: 1245.28.34003 Boehringer Ingelheim Investigational Site
city: Granada
country: Spain
facility: 1245.28.34009 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1245.28.34012 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1245.28.34013 Boehringer Ingelheim Investigational Site
city: Mataró
country: Spain
facility: 1245.28.34005 Boehringer Ingelheim Investigational Site
city: Pineda de Mar
country: Spain
facility: 1245.28.34001 Boehringer Ingelheim Investigational Site
city: San Sebastian de los Reyes
country: Spain
facility: 1245.28.34010 Boehringer Ingelheim Investigational Site
city: Tarrega - Lleida
country: Spain
facility: 1245.28.34006 Boehringer Ingelheim Investigational Site
city: Borås
country: Sweden
facility: 1245.28.46009 Boehringer Ingelheim Investigational Site
city: Lund
country: Sweden
facility: 1245.28.46008 Boehringer Ingelheim Investigational Site
city: Malmö
country: Sweden
facility: 1245.28.46001 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1245.28.46002 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1245.28.46006 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1245.28.46007 Boehringer Ingelheim Investigational Site
city: Uppsala
country: Sweden
facility: 1245.28.46004 Boehringer Ingelheim Investigational Site
city: Örebro
country: Sweden
facility: 1245.28.46005 Boehringer Ingelheim Investigational Site
city: Ascona
country: Switzerland
facility: 1245.28.41015 Boehringer Ingelheim Investigational Site
city: Bern
country: Switzerland
facility: 1245.28.41017 Inselspital Bern
city: Changhua
country: Taiwan
facility: 1245.28.88004 Boehringer Ingelheim Investigational Site
city: Taichung
country: Taiwan
facility: 1245.28.88003 Boehringer Ingelheim Investigational Site
city: Tainan Hsien
country: Taiwan
facility: 1245.28.88005 Boehringer Ingelheim Investigational Site
city: Taipei Hsien
country: Taiwan
facility: 1245.28.88002 Boehringer Ingelheim Investigational Site
city: Taipei
country: Taiwan
facility: 1245.28.88001 Boehringer Ingelheim Investigational Site
city: Bangkok
country: Thailand
facility: 1245.28.66006 Boehringer Ingelheim Investigational Site
city: Bangkok
country: Thailand
facility: 1245.28.66007 Boehringer Ingelheim Investigational Site
city: Muang District
country: Thailand
facility: 1245.28.66004 Boehringer Ingelheim Investigational Site
city: Nakhonratchasima
country: Thailand
facility: 1245.28.66008 Boehringer Ingelheim Investigational Site
city: Addlestone
country: United Kingdom
facility: 1245.28.44006 Boehringer Ingelheim Investigational Site
city: Ashford
country: United Kingdom
facility: 1245.28.44020 Boehringer Ingelheim Investigational Site
city: Balham
country: United Kingdom
facility: 1245.28.44008 Boehringer Ingelheim Investigational Site
city: Barnstable
country: United Kingdom
facility: 1245.28.44035 Boehringer Ingelheim Investigational Site
city: Blackpool
country: United Kingdom
facility: 1245.28.44016 Boehringer Ingelheim Investigational Site
city: Bradford on Avon
country: United Kingdom
facility: 1245.28.44021 Boehringer Ingelheim Investigational Site
city: Burbage
country: United Kingdom
facility: 1245.28.44019 Boehringer Ingelheim Investigational Site
city: Chestfield, Whitstable
country: United Kingdom
facility: 1245.28.44027 Boehringer Ingelheim Investigational Site
city: Chippenham
country: United Kingdom
facility: 1245.28.44011 Boehringer Ingelheim Investigational Site
city: Chippenham
country: United Kingdom
facility: 1245.28.44022 Boehringer Ingelheim Investigational Site
city: Coventry
country: United Kingdom
facility: 1245.28.44043 Boehringer Ingelheim Investigational Site
city: Doncaster
country: United Kingdom
facility: 1245.28.44025 Boehringer Ingelheim Investigational Site
city: Ely
country: United Kingdom
facility: 1245.28.44030 Boehringer Ingelheim Investigational Site
city: Midsomer Norton
country: United Kingdom
facility: 1245.28.44007 Boehringer Ingelheim Investigational Site
city: Nantwich
country: United Kingdom
facility: 1245.28.44023 Boehringer Ingelheim Investigational Site
city: Whitstable
country: United Kingdom
facility: 1245.28.44017 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Salem A, Men P, Ramos M, Zhang YJ, Ustyugova A, Lamotte M. Cost-effectiveness analysis of empagliflozin compared with glimepiride in patients with Type 2 diabetes in China. J Comp Eff Res. 2021 Apr;10(6):469-480. doi: 10.2217/cer-2020-0284. Epub 2021 Feb 12.
citation: Ridderstrale 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.
citation: Ridderstrale 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.