Clinical trial NCT01422876: Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients
Official title: A Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Once Daily Oral Administration of BI 10773 25 mg/Linagliptin 5 mg and BI 10773 10 mg/Linagliptin 5 mg Fixed Dose Combination Tablets Compared With the Individual Components (BI 10773 25 mg, BI 10773 10 mg, and Linagliptin 5 mg) for 52 Weeks in Treatment naïve and Metformin Treated Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control
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: 2011-08-25
Enrollment: 1405
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 trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to support approval by regulatory authorities.


Eligibility criteria: 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 (defined as absence of any oral antidiabetic therapy, glucagon like peptide-1 analog or insulin for 12 weeks prior to randomization) or pre-treated with metformin (=1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
3. Glycosylated hemoglobin (HbA1c) = 7.0% and = 10.5% (= 53.0 mmol/mol and = 91.3 mmol/mol) at Visit 1 (screening)

Exclusion criteria:

1. Uncontrolled hyperglycemia 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 drug within 12 weeks prior to randomization (except metformin background therapy as defined via inclusion criterion 2)
3. Acute coronary syndrome (non-ST elevation myocardial infarction, ST elevation myocardial infarction and unstable angina pectoris), stroke or (transient ischemic attack) TIA within 3 months prior to informed consent

Primary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Metformin Background Patients
timeFrame: Baseline and 24 weeks
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Treatment Naive Patients
timeFrame: Baseline and 24 weeks
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose at Week 24 for Metformin Background Patients
timeFrame: Baseline and 24 Weeks
measure: Change From Baseline in Fasting Plasma Glucose at Week 24 for Treatment Naive Patients
timeFrame: Baseline and 24 Weeks
measure: Change From Baseline in Body Weight for Metformin Background Patients
timeFrame: Baseline and 24 Weeks
measure: Change From Baseline in Body Weight for Treatment Naive Patients
timeFrame: Baseline and 24 Weeks
measure: Occurrence of Treat to Target Efficacy Response for Metformin Background Patients
timeFrame: 24 Weeks
measure: Occurrence of Treat to Target Efficacy Response for Treatment Naive Patients
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 1275.1.01103 Boehringer Ingelheim Investigational Site
state: Alabama
city: Foley
country: United States
facility: 1275.1.01107 Boehringer Ingelheim Investigational Site
state: Alabama
city: Mobile
country: United States
facility: 1275.1.01043 Boehringer Ingelheim Investigational Site
state: Alabama
city: Mobile
country: United States
facility: 1275.1.01066 Boehringer Ingelheim Investigational Site
state: Alabama
city: Pell City
country: United States
facility: 1275.1.01047 Boehringer Ingelheim Investigational Site
state: Alabama
city: Mesa
country: United States
facility: 1275.1.01089 Boehringer Ingelheim Investigational Site
state: Arizona
city: Tempe
country: United States
facility: 1275.1.01064 Boehringer Ingelheim Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: 1275.1.01028 Boehringer Ingelheim Investigational Site
state: Arkansas
city: Cerritos
country: United States
facility: 1275.1.01086 Boehringer Ingelheim Investigational Site
state: California
city: Chula Vista
country: United States
facility: 1275.1.01067 Boehringer Ingelheim Investigational Site
state: California
city: Encino
country: United States
facility: 1275.1.01109 Boehringer Ingelheim Investigational Site
state: California
city: Fresno
country: United States
facility: 1275.1.01012 Boehringer Ingelheim Investigational Site
state: California
city: Harbor City
country: United States
facility: 1275.1.01050 Boehringer Ingelheim Investigational Site
state: California
city: Huntington Park
country: United States
facility: 1275.1.01056 Boehringer Ingelheim Investigational Site
state: California
city: Long Beach
country: United States
facility: 1275.1.01021 Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: 1275.1.01024 Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: 1275.1.01112 Boehringer Ingelheim Investigational Site
state: California
city: Oceanside
country: United States
facility: 1275.1.01083 Boehringer Ingelheim Investigational Site
state: California
city: San Dimas
country: United States
facility: 1275.1.01071 Boehringer Ingelheim Investigational Site
state: California
city: Tustin
country: United States
facility: 1275.1.01044 Boehringer Ingelheim Investigational Site
state: California
city: Colorado Springs
country: United States
facility: 1275.1.01078 Boehringer Ingelheim Investigational Site
state: Colorado
city: Colorado Springs
country: United States
facility: 1275.1.01124 Boehringer Ingelheim Investigational Site
state: Colorado
city: Denver
country: United States
facility: 1275.1.01010 Boehringer Ingelheim Investigational Site
state: Colorado
city: Denver
country: United States
facility: 1275.1.01048 Boehringer Ingelheim Investigational Site
state: Colorado
city: Gainesville
country: United States
facility: 1275.1.01073 Boehringer Ingelheim Investigational Site
state: Florida
city: Hialeah
country: United States
facility: 1275.1.01063 Boehringer Ingelheim Investigational Site
state: Florida
city: Hialeah
country: United States
facility: 1275.1.01077 Boehringer Ingelheim Investigational Site
state: Florida
city: Inverness
country: United States
facility: 1275.1.01090 Boehringer Ingelheim Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: 1275.1.01054 Boehringer Ingelheim Investigational Site
state: Florida
city: Maitland
country: United States
facility: 1275.1.01092 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami Beach
country: United States
facility: 1275.1.01040 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami Lakes
country: United States
facility: 1275.1.01025 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: 1275.1.01065 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: 1275.1.01110 Boehringer Ingelheim Investigational Site
state: Florida
city: Orlando
country: United States
facility: 1275.1.01094 Boehringer Ingelheim Investigational Site
state: Florida
city: Ormond Beach
country: United States
facility: 1275.1.01068 Boehringer Ingelheim Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: 1275.1.01051 Boehringer Ingelheim Investigational Site
state: Florida
city: Port Orange
country: United States
facility: 1275.1.01079 Boehringer Ingelheim Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: 1275.1.01117 Boehringer Ingelheim Investigational Site
state: Florida
city: Atlanta
country: United States
facility: 1275.1.01039 Boehringer Ingelheim Investigational Site
state: Georgia
city: Marietta
country: United States
facility: 1275.1.01007 Boehringer Ingelheim Investigational Site
state: Georgia
city: Norcross
country: United States
facility: 1275.1.01111 Boehringer Ingelheim Investigational Site
state: Georgia
city: Savannah
country: United States
facility: 1275.1.01076 Boehringer Ingelheim Investigational Site
state: Georgia
city: Addison
country: United States
facility: 1275.1.01100 Boehringer Ingelheim Investigational Site
state: Illinois
city: Des Moines
country: United States
facility: 1275.1.01042 Boehringer Ingelheim Investigational Site
state: Iowa
city: Paducah
country: United States
facility: 1275.1.01059 Boehringer Ingelheim Investigational Site
state: Kentucky
city: Shreveport
country: United States
facility: 1275.1.01003 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Hyattsville
country: United States
facility: 1275.1.01125 Boehringer Ingelheim Investigational Site
state: Maryland
city: Boston
country: United States
facility: 1275.1.01081 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Rochester
country: United States
facility: 1275.1.01085 Boehringer Ingelheim Investigational Site
state: Michigan
city: Southfield
country: United States
facility: 1275.1.01035 Boehringer Ingelheim Investigational Site
state: Michigan
city: St. Louis
country: United States
facility: 1275.1.01023 Boehringer Ingelheim Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: 1275.1.01027 Boehringer Ingelheim Investigational Site
state: Missouri
city: Great Falls
country: United States
facility: 1275.1.01033 Boehringer Ingelheim Investigational Site
state: Montana
city: Henderson
country: United States
facility: 1275.1.01099 Boehringer Ingelheim Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: 1275.1.01101 Boehringer Ingelheim Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: 1275.1.01114 Boehringer Ingelheim Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: 1275.1.01123 Boehringer Ingelheim Investigational Site
state: Nevada
city: Elizabeth
country: United States
facility: 1275.1.01013 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: 1275.1.01057 Boehringer Ingelheim Investigational Site
state: New Mexico
city: Binghamton
country: United States
facility: 1275.1.01002 Boehringer Ingelheim Investigational Site
state: New York
city: Endwell
country: United States
facility: 1275.1.01020 Boehringer Ingelheim Investigational Site
state: New York
city: Flushing
country: United States
facility: 1275.1.01095 Boehringer Ingelheim Investigational Site
state: New York
city: Glens Falls
country: United States
facility: 1275.1.01062 Boehringer Ingelheim Investigational Site
state: New York
city: New York
country: United States
facility: 1275.1.01006 Boehringer Ingelheim Investigational Site
state: New York
city: Asheboro
country: United States
facility: 1275.1.01011 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Burlington
country: United States
facility: 1275.1.01052 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: 1275.1.01045 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Akron
country: United States
facility: 1275.1.01001 Boehringer Ingelheim Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: 1275.1.01032 Boehringer Ingelheim Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: 1275.1.01061 Boehringer Ingelheim Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: 1275.1.01116 Boehringer Ingelheim Investigational Site
state: Ohio
city: Columbus
country: United States
facility: 1275.1.01016 Boehringer Ingelheim Investigational Site
state: Ohio
city: Columbus
country: United States
facility: 1275.1.01102 Boehringer Ingelheim Investigational Site
state: Ohio
city: Dayton
country: United States
facility: 1275.1.01017 Boehringer Ingelheim Investigational Site
state: Ohio
city: Dayton
country: United States
facility: 1275.1.01036 Boehringer Ingelheim Investigational Site
state: Ohio
city: Delaware
country: United States
facility: 1275.1.01030 Boehringer Ingelheim Investigational Site
state: Ohio
city: Groveport
country: United States
facility: 1275.1.01055 Boehringer Ingelheim Investigational Site
state: Ohio
city: Wadsworth
country: United States
facility: 1275.1.01075 Boehringer Ingelheim Investigational Site
state: Ohio
city: Norman
country: United States
facility: 1275.1.01034 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Corvallis
country: United States
facility: 1275.1.01082 Boehringer Ingelheim Investigational Site
state: Oregon
city: Altoona
country: United States
facility: 1275.1.01084 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Fleetwood
country: United States
facility: 1275.1.01038 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: 1275.1.01019 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Scottdale
country: United States
facility: 1275.1.01072 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Tipton
country: United States
facility: 1275.1.01088 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Uniontown
country: United States
facility: 1275.1.01014 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Uniontown
country: United States
facility: 1275.1.01060 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: 1275.1.01093 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Florence
country: United States
facility: 1275.1.01122 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Hodges
country: United States
facility: 1275.1.01005 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Brentwood
country: United States
facility: 1275.1.01015 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Chattanooga
country: United States
facility: 1275.1.01031 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: 1275.1.01121 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Spring Hill
country: United States
facility: 1275.1.01069 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Austin
country: United States
facility: 1275.1.01049 Boehringer Ingelheim Investigational Site
state: Texas
city: Austin
country: United States
facility: 1275.1.01080 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1275.1.01029 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1275.1.01053 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1275.1.01106 Boehringer Ingelheim Investigational Site
state: Texas
city: Pearland
country: United States
facility: 1275.1.01018 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 1275.1.01096 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 1275.1.01113 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 1275.1.01120 Boehringer Ingelheim Investigational Site
state: Texas
city: Spring
country: United States
facility: 1275.1.01105 Boehringer Ingelheim Investigational Site
state: Texas
city: Waco
country: United States
facility: 1275.1.01037 Boehringer Ingelheim Investigational Site
state: Texas
city: Bountiful
country: United States
facility: 1275.1.01008 Boehringer Ingelheim Investigational Site
state: Utah
city: West Jordan
country: United States
facility: 1275.1.01022 Boehringer Ingelheim Investigational Site
state: Utah
city: South Chesterfield
country: United States
facility: 1275.1.01091 Boehringer Ingelheim Investigational Site
state: Virginia
city: Selah
country: United States
facility: 1275.1.01118 Boehringer Ingelheim Investigational Site
state: Washington
city: Shoreline
country: United States
facility: 1275.1.01087 Boehringer Ingelheim Investigational Site
state: Washington
city: Spokane
country: United States
facility: 1275.1.01119 Boehringer Ingelheim Investigational Site
state: Washington
city: Caba
country: Argentina
facility: 1275.1.54001 Boehringer Ingelheim Investigational Site
city: Capital Federal
country: Argentina
facility: 1275.1.54005 Boehringer Ingelheim Investigational Site
city: Cordoba
country: Argentina
facility: 1275.1.54003 Boehringer Ingelheim Investigational Site
city: Mar del Plata
country: Argentina
facility: 1275.1.54004 Boehringer Ingelheim Investigational Site
city: Mendoza
country: Argentina
facility: 1275.1.54002 Boehringer Ingelheim Investigational Site
city: Wollongong
country: Australia
facility: 1275.1.61003 Boehringer Ingelheim Investigational Site
state: New South Wales
city: East Ringwood
country: Australia
facility: 1275.1.61002 Boehringer Ingelheim Investigational Site
state: Victoria
city: Joaquim Távora
country: Brazil
facility: 1275.1.55002 Boehringer Ingelheim Investigational Site
city: Rio de Janeiro - RJ
country: Brazil
facility: 1275.1.55001 Boehringer Ingelheim Investigational Site
city: Sao Paulo
country: Brazil
facility: 1275.1.55005 Boehringer Ingelheim Investigational Site
city: Plovdiv
country: Bulgaria
facility: 1275.1.59003 Boehringer Ingelheim Investigational Site
city: Ruse
country: Bulgaria
facility: 1275.1.59006 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1275.1.59004 Boehringer Ingelheim Investigational Site
city: Bathurst
country: Canada
facility: 1275.1.20008 Boehringer Ingelheim Investigational Site
state: New Brunswick
city: Bay Roberts
country: Canada
facility: 1275.1.20007 Boehringer Ingelheim Investigational Site
state: Newfoundland and Labrador
city: Mount Pearl
country: Canada
facility: 1275.1.20006 Boehringer Ingelheim Investigational Site
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: 1275.1.20004 Boehringer Ingelheim Investigational Site
state: Newfoundland and Labrador
city: Brampton
country: Canada
facility: 1275.1.20001 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 1275.1.20005 Boehringer Ingelheim Investigational Site
state: Ontario
city: Drummondville
country: Canada
facility: 1275.1.20003 Boehringer Ingelheim Investigational Site
state: Quebec
city: Pointe Claire
country: Canada
facility: 1275.1.20002 Boehringer Ingelheim Investigational Site
state: Quebec
city: Barranquilla
country: Colombia
facility: 1275.1.57004 Boehringer Ingelheim Investigational Site
city: Bogota
country: Colombia
facility: 1275.1.57005 Boehringer Ingelheim Investigational Site
city: Bogotá
country: Colombia
facility: 1275.1.57002 Boehringer Ingelheim Investigational Site
city: Tolima
country: Colombia
facility: 1275.1.57003 Boehringer Ingelheim Investigational Site
city: Aalborg
country: Denmark
facility: 1275.1.45004 Boehringer Ingelheim Investigational Site
city: Aarhus C
country: Denmark
facility: 1275.1.45003 Boehringer Ingelheim Investigational Site
city: København NV
country: Denmark
facility: 1275.1.45002 Boehringer Ingelheim Investigational Site
city: Kivioli
country: Estonia
facility: 1275.1.37206 Boehringer Ingelheim Investigational Site
city: Pärnu
country: Estonia
facility: 1275.1.37202 Boehringer Ingelheim Investigational Site
city: Tallinn
country: Estonia
facility: 1275.1.37201 Boehringer Ingelheim Investigational Site
city: Tallinn
country: Estonia
facility: 1275.1.37204 Boehringer Ingelheim Investigational Site
city: Viljandi County
country: Estonia
facility: 1275.1.37203 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 1275.1.36002 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 1275.1.36003 Boehringer Ingelheim Investigational Site
city: Gyongyos
country: Hungary
facility: 1275.1.36001 Boehringer Ingelheim Investigational Site
city: Bassano del Grappa (VI)
country: Italy
facility: 1275.1.39003 Boehringer Ingelheim Investigational Site
city: Fermo
country: Italy
facility: 1275.1.39002 Boehringer Ingelheim Investigational Site
city: Milan
country: Italy
facility: 1275.1.39001 Boehringer Ingelheim Investigational Site
city: Roma
country: Italy
facility: 1275.1.39004 Boehringer Ingelheim Investigational Site
city: Baabda
country: Lebanon
facility: 1275.1.96004 Boehringer Ingelheim Investigational Site
city: Beirut
country: Lebanon
facility: 1275.1.96002 Boehringer Ingelheim Investigational Site
city: Beirut
country: Lebanon
facility: 1275.1.96003 Boehringer Ingelheim Investigational Site
city: Beirut
country: Lebanon
facility: 1275.1.96006 Boehringer Ingelheim Investigational Site
city: Beirut
country: Lebanon
facility: 1275.1.96008 Boehringer Ingelheim Investigational Site
city: Saida
country: Lebanon
facility: 1275.1.96007 Boehringer Ingelheim Investigational Site
city: Kedah
country: Malaysia
facility: 1275.1.60001 Boehringer Ingelheim Investigational Site
city: Perak
country: Malaysia
facility: 1275.1.60002 Boehringer Ingelheim Investigational Site
city: Mexico
country: Mexico
facility: 1275.1.52002 Boehringer Ingelheim Investigational Site
city: Mexico
country: Mexico
facility: 1275.1.52005 Boehringer Ingelheim Investigational Site
city: Monterrey
country: Mexico
facility: 1275.1.52003 Boehringer Ingelheim Investigational Site
city: Pachuca
country: Mexico
facility: 1275.1.52001 Boehringer Ingelheim Investigational Site
city: San Luis Potosí
country: Mexico
facility: 1275.1.52004 Boehringer Ingelheim Investigational Site
city: Arequipa
country: Peru
facility: 1275.1.51001 Boehringer Ingelheim Investigational Site
city: Ica
country: Peru
facility: 1275.1.51003 Boehringer Ingelheim Investigational Site
city: Lima
country: Peru
facility: 1275.1.51002 Boehringer Ingelheim Investigational Site
city: Lima
country: Peru
facility: 1275.1.51004 Boehringer Ingelheim Investigational Site
city: Lima
country: Peru
facility: 1275.1.51005 Boehringer Ingelheim Investigational Site
city: Davao
country: Philippines
facility: 1275.1.63002 Boehringer Ingelheim Investigational Site
city: Greenhills, San Juan
country: Philippines
facility: 1275.1.63001 Boehringer Ingelheim Investigational Site
city: Manila
country: Philippines
facility: 1275.1.63004 Boehringer Ingelheim Investigational Site
city: Marikina city
country: Philippines
facility: 1275.1.63006 Boehringer Ingelheim Investigational Site
city: Pasay City
country: Philippines
facility: 1275.1.63003 Boehringer Ingelheim Investigational Site
city: Pasig
country: Philippines
facility: 1275.1.63005 Boehringer Ingelheim Investigational Site
city: Lodz
country: Poland
facility: 1275.1.48002 Boehringer Ingelheim Investigational Site
city: Poznan
country: Poland
facility: 1275.1.48004 Boehringer Ingelheim Investigational Site
city: Warsaw
country: Poland
facility: 1275.1.48001 Boehringer Ingelheim Investigational Site
city: Warsaw
country: Poland
facility: 1275.1.48003 Boehringer Ingelheim Investigational Site
city: Alba Iulia
country: Romania
facility: 1275.1.40001 Boehringer Ingelheim Investigational Site
city: Baia Mare Maramures
country: Romania
facility: 1275.1.40005 Boehringer Ingelheim Investigational Site
city: Brasov
country: Romania
facility: 1275.1.40004 Boehringer Ingelheim Investigational Site
city: Bucharest
country: Romania
facility: 1275.1.40008 Boehringer Ingelheim Investigational Site
city: Bucharest
country: Romania
facility: 1275.1.40009 Boehringer Ingelheim Investigational Site
city: Cluj-Napoca
country: Romania
facility: 1275.1.40006 Boehringer Ingelheim Investigational Site
city: Galati
country: Romania
facility: 1275.1.40007 Boehringer Ingelheim Investigational Site
city: Oradea
country: Romania
facility: 1275.1.40002 Boehringer Ingelheim Investigational Site
city: Sibiu
country: Romania
facility: 1275.1.40010 Boehringer Ingelheim Investigational Site
city: Targu-Mures
country: Romania
facility: 1275.1.40003 Boehringer Ingelheim Investigational Site
city: Arkhangelsk
country: Russian Federation
facility: 1275.1.70006 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1275.1.70001 Boehringer Ingelheim Investigational Site
city: Samara
country: Russian Federation
facility: 1275.1.70004 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1275.1.70002 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1275.1.70003 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1275.1.70005 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1275.1.34004 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1275.1.34005 Boehringer Ingelheim Investigational Site
city: Hospitalet de Llobegrat
country: Spain
facility: 1275.1.34002 Boehringer Ingelheim Investigational Site
city: Palma de Mallorca
country: Spain
facility: 1275.1.34003 Boehringer Ingelheim Investigational Site
city: Tarragona
country: Spain
facility: 1275.1.34006 Boehringer Ingelheim Investigational Site
city: Järfälla
country: Sweden
facility: 1275.1.46003 Boehringer Ingelheim Investigational Site
city: Rättvik
country: Sweden
facility: 1275.1.46004 Boehringer Ingelheim Investigational Site
city: Skene
country: Sweden
facility: 1275.1.46002 Boehringer Ingelheim Investigational Site
city: Chiayi
country: Taiwan
facility: 1275.1.88006 Chang Gung Memorial Hospital-CY
city: Kaohsiung
country: Taiwan
facility: 1275.1.88007 E-Da Hospital
city: New Taipei
country: Taiwan
facility: 1275.1.88001 Cardinal Tien Hospital
city: Taichung
country: Taiwan
facility: 1275.1.88004 Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: 1275.1.88008 Chi Mei Medical Center
city: Taipei
country: Taiwan
facility: 1275.1.88002 Far Eastern Memorial Hospital
city: Taipei
country: Taiwan
facility: 1275.1.88003 Taipei Chang Gung Memorial Hospital
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: DeFronzo RA, Lee C, Kohler S. Safety and Tolerability of Combinations of Empagliflozin and Linagliptin in Patients with Type 2 Diabetes: Pooled Data from Two Randomized Controlled Trials. Adv Ther. 2018 Jul;35(7):1009-1022. doi: 10.1007/s12325-018-0724-y. Epub 2018 Jun 15.
citation: Lewin A, DeFronzo RA, Patel S, Liu D, Kaste R, Woerle HJ, Broedl UC. Initial combination of empagliflozin and linagliptin in subjects with type 2 diabetes. Diabetes Care. 2015 Mar;38(3):394-402. doi: 10.2337/dc14-2365. Epub 2015 Jan 29.
citation: DeFronzo RA, Lewin A, Patel S, Liu D, Kaste R, Woerle HJ, Broedl UC. Combination of empagliflozin and linagliptin as second-line therapy in subjects with type 2 diabetes inadequately controlled on metformin. Diabetes Care. 2015 Mar;38(3):384-93. doi: 10.2337/dc14-2364. Epub 2015 Jan 12.