Clinical trial NCT01289990: Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes
Official title: A Phase III Double-blind, Extension, Placebo-controlled Parallel Group Safety and Efficacy Trial of BI 10773 (10 and 25mg Once Daily) and Sitagliptin (100mg Once Daily) Given for Minimum 76 Weeks (Incl. 24 Weeks of Preceding Trial) as Monotherapy or With Different Back-ground Therapies in Patients With Type 2 Diabetes Mellitus Previously Completing Trial 1245.19, 1245.20 or 1245.23
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: 2011-02-04
Enrollment: 2705
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the efficacy and long term safety and tolerability of BI 10773 in type 2 diabetic patients.


Eligibility criteria: Inclusion criteria:

1. Patients completing the entire treatment period of the preceding double-blind trial 1245.19, 1245.20 or 1245.23 with or without rescue therapy.
2. Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice and local legislation.

Exclusion criteria:

1. Patient who meet one or more of the withdrawal criteria of the treatment period of the previous trial 1245.19, 1245.20 or 1245.23.
2. Indication of liver disease, defined by serum levels of either alanine aminotransferase , aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal as determined during last visit of preceding trial.
3. Impaired renal function defined as glomerular filtration rate\<30 ml/min (severe renal impairment, Modification of Diet in Renal Disease formula) as determined during last visit of preceding trial.
4. Contraindications to sitagliptin, pioglitazone, metformin or sulfonylurea according to local label, which started during trial participation in 1245.19, 1245.20 or 1245.23
5. Pre-menopausal women (last menstruation \< or = 1 year prior to informed consent) who are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner.
6. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake.
7. Participation in another trial with an investigational drug within 30 days prior to informed consent (except 1245.19, 1245.20 and 1245.23).
8. Any other clinical condition that would jeopardize patient's safety while participating in this clinical trial.

Primary outcomes:
measure: Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment
timeFrame: Baseline and 52 weeks
measure: Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment
timeFrame: Baseline and 76 weeks
Secondary outcomes:
measure: HbA1c (%) Changes From Baseline After 76 Weeks of Treatment
timeFrame: Baseline and 76 weeks
measure: Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
timeFrame: Baseline and 52 weeks
measure: Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
timeFrame: Baseline and 76 weeks
measure: Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
timeFrame: Baseline and 52 weeks
measure: Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
timeFrame: Baseline and 76 weeks
measure: Body Weight (kg) Change From Baseline After 52 Weeks of Treatment
timeFrame: Baseline and 52 weeks
measure: Body Weight (kg) Change From Baseline After 76 Weeks of Treatment
timeFrame: Baseline and 76 weeks
measure: Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment
timeFrame: Baseline and 52 weeks
measure: Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment
timeFrame: Baseline and 76 weeks
measure: Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment
timeFrame: Baseline and 52 weeks
measure: Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment
timeFrame: Baseline and 76 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 1245.31.10145 Boehringer Ingelheim Investigational Site
state: Alabama
city: Glendale
country: United States
facility: 1245.31.10162 Boehringer Ingelheim Investigational Site
state: Arizona
city: Mesa
country: United States
facility: 1245.31.10124 Boehringer Ingelheim Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: 1245.31.10108 Boehringer Ingelheim Investigational Site
state: Arizona
city: Tempe
country: United States
facility: 1245.31.10046 Boehringer Ingelheim Investigational Site
state: Arizona
city: Chino
country: United States
facility: 1245.31.10154 Boehringer Ingelheim Investigational Site
state: California
city: Rancho Cucamonga
country: United States
facility: 1245.31.10149 Boehringer Ingelheim Investigational Site
state: California
city: West Hills
country: United States
facility: 1245.31.10131 Boehringer Ingelheim Investigational Site
state: California
city: Northglenn
country: United States
facility: 1245.31.10038 Boehringer Ingelheim Investigational Site
state: Colorado
city: Waterbury
country: United States
facility: 1245.31.10127 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Clearwater
country: United States
facility: 1245.31.10137 Boehringer Ingelheim Investigational Site
state: Florida
city: Jupiter
country: United States
facility: 1245.31.10133 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: 1245.31.10006 Boehringer Ingelheim Investigational Site
state: Florida
city: Plantation
country: United States
facility: 1245.31.10085 Boehringer Ingelheim Investigational Site
state: Florida
city: Decatur
country: United States
facility: 1245.31.10080 Boehringer Ingelheim Investigational Site
state: Georgia
city: Perry
country: United States
facility: 1245.31.10077 Boehringer Ingelheim Investigational Site
state: Georgia
city: Chicago
country: United States
facility: 1245.31.10001 Boehringer Ingelheim Investigational Site
state: Illinois
city: Des Moines
country: United States
facility: 1245.31.10159 Boehringer Ingelheim Investigational Site
state: Iowa
city: Dubuque
country: United States
facility: 1245.31.10014 Boehringer Ingelheim Investigational Site
state: Iowa
city: Arkansas City
country: United States
facility: 1245.31.10117 Boehringer Ingelheim Investigational Site
state: Kansas
city: Newton
country: United States
facility: 1245.31.10157 Boehringer Ingelheim Investigational Site
state: Kansas
city: Louisville
country: United States
facility: 1245.31.10146 Boehringer Ingelheim Investigational Site
state: Kentucky
city: Dearborn
country: United States
facility: 1245.31.10003 Boehringer Ingelheim Investigational Site
state: Michigan
city: New Hyde Park
country: United States
facility: 1245.31.10059 Boehringer Ingelheim Investigational Site
state: New York
city: Rochester
country: United States
facility: 1245.31.10034 Boehringer Ingelheim Investigational Site
state: New York
city: Smithtown
country: United States
facility: 1245.31.10123 Boehringer Ingelheim Investigational Site
state: New York
city: Asheboro
country: United States
facility: 1245.31.10071 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Salisbury
country: United States
facility: 1245.31.10086 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Carlisle
country: United States
facility: 1245.31.10129 Boehringer Ingelheim Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: 1245.31.10045 Boehringer Ingelheim Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: 1245.31.10119 Boehringer Ingelheim Investigational Site
state: Ohio
city: Gallipolis
country: United States
facility: 1245.31.10130 Boehringer Ingelheim Investigational Site
state: Ohio
city: Mount Pleasant
country: United States
facility: 1245.31.10158 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Simpsonville
country: United States
facility: 1245.31.10015 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Chattanooga
country: United States
facility: 1245.31.10033 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: 1245.31.10112 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Houston
country: United States
facility: 1245.31.10156 Boehringer Ingelheim Investigational Site
state: Texas
city: Hurst
country: United States
facility: 1245.31.10151 Boehringer Ingelheim Investigational Site
state: Texas
city: Killeen
country: United States
facility: 1245.31.10143 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 1245.31.10155 Boehringer Ingelheim Investigational Site
state: Texas
city: Bruxelles
country: Belgium
facility: 1245.31.32008 Boehringer Ingelheim Investigational Site
city: Bruxelles
country: Belgium
facility: 1245.31.32023 Boehringer Ingelheim Investigational Site
city: De Pinte
country: Belgium
facility: 1245.31.32003 Boehringer Ingelheim Investigational Site
city: Deurne
country: Belgium
facility: 1245.31.32015 Boehringer Ingelheim Investigational Site
city: Deurne
country: Belgium
facility: 1245.31.32016 Boehringer Ingelheim Investigational Site
city: Gozée
country: Belgium
facility: 1245.31.32025 Boehringer Ingelheim Investigational Site
city: Leopoldsburg
country: Belgium
facility: 1245.31.32019 Boehringer Ingelheim Investigational Site
city: Linkebeek
country: Belgium
facility: 1245.31.32024 Boehringer Ingelheim Investigational Site
city: Mouscron
country: Belgium
facility: 1245.31.32021 Boehringer Ingelheim Investigational Site
city: Sint-Gillis-Waas
country: Belgium
facility: 1245.31.32020 Boehringer Ingelheim Investigational Site
city: Tielt
country: Belgium
facility: 1245.31.32018 Boehringer Ingelheim Investigational Site
city: Tremelo
country: Belgium
facility: 1245.31.32026 Boehringer Ingelheim Investigational Site
city: Calgary
country: Canada
facility: 1245.31.20032 Boehringer Ingelheim Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: 1245.31.20023 Boehringer Ingelheim Investigational Site
state: Alberta
city: Chilliwack
country: Canada
facility: 1245.31.20011 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: 1245.31.20028 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Victoria
country: Canada
facility: 1245.31.20018 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Victoria
country: Canada
facility: 1245.31.20033 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: 1245.31.20015 Boehringer Ingelheim Investigational Site
state: Manitoba
city: Moncton
country: Canada
facility: 1245.31.20012 Boehringer Ingelheim Investigational Site
state: New Brunswick
city: Mount Pearl
country: Canada
facility: 1245.31.20016 Boehringer Ingelheim Investigational Site
state: Newfoundland and Labrador
city: Paradise
country: Canada
facility: 1245.31.20024 Boehringer Ingelheim Investigational Site
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: 1245.31.20008 Boehringer Ingelheim Investigational Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: 1245.31.20026 Boehringer Ingelheim Investigational Site
state: Nova Scotia
city: Brampton
country: Canada
facility: 1245.31.20022 Boehringer Ingelheim Investigational Site
state: Ontario
city: Brampton
country: Canada
facility: 1245.31.20057 Boehringer Ingelheim Investigational Site
state: Ontario
city: Corunna
country: Canada
facility: 1245.31.20035 Boehringer Ingelheim Investigational Site
state: Ontario
city: Etobicoke
country: Canada
facility: 1245.31.20030 Boehringer Ingelheim Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: 1245.31.20019 Boehringer Ingelheim Investigational Site
state: Ontario
city: London
country: Canada
facility: 1245.31.20017 Boehringer Ingelheim Investigational Site
state: Ontario
city: London
country: Canada
facility: 1245.31.20029 Boehringer Ingelheim Investigational Site
state: Ontario
city: London
country: Canada
facility: 1245.31.20060 Boehringer Ingelheim Investigational Site
state: Ontario
city: Markham
country: Canada
facility: 1245.31.20003 Boehringer Ingelheim Investigational Site
state: Ontario
city: Newmarket
country: Canada
facility: 1245.31.20009 Boehringer Ingelheim Investigational Site
state: Ontario
city: Oakville
country: Canada
facility: 1245.31.20040 Boehringer Ingelheim Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: 1245.31.20034 Boehringer Ingelheim Investigational Site
state: Ontario
city: Strathroy
country: Canada
facility: 1245.31.20005 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 1245.31.20002 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 1245.31.20006 Boehringer Ingelheim Investigational Site
state: Ontario
city: Montague
country: Canada
facility: 1245.31.20007 Boehringer Ingelheim Investigational Site
state: Prince Edward Island
city: Laval
country: Canada
facility: 1245.31.20027 Boehringer Ingelheim Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: 1245.31.20025 Boehringer Ingelheim Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: 1245.31.20036 Boehringer Ingelheim Investigational Site
state: Quebec
city: St-Romuald
country: Canada
facility: 1245.31.20058 Boehringer Ingelheim Investigational Site
state: Quebec
city: Trois Rivieres
country: Canada
facility: 1245.31.20021 Boehringer Ingelheim Investigational Site
state: Quebec
city: Ville Saint-Laurent
country: Canada
facility: 1245.31.20038 Boehringer Ingelheim Investigational Site
state: Quebec
city: Saskatoon
country: Canada
facility: 1245.31.20041 Boehringer Ingelheim Investigational Site
state: Saskatchewan
city: Beijing
country: China
facility: 1245.31.86007 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 1245.31.86008 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 1245.31.86031 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 1245.31.86032 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 1245.31.86033 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 1245.31.86034 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 1245.31.86035 Boehringer Ingelheim Investigational Site
city: Chongqing
country: China
facility: 1245.31.86058 Boehringer Ingelheim Investigational Site
city: Dalian
country: China
facility: 1245.31.86038 Boehringer Ingelheim Investigational Site
city: Guangzhou
country: China
facility: 1245.31.86001 Boehringer Ingelheim Investigational Site
city: Guangzhou
country: China
facility: 1245.31.86003 Boehringer Ingelheim Investigational Site
city: Guangzhou
country: China
facility: 1245.31.86052 Boehringer Ingelheim Investigational Site
city: Guiyang
country: China
facility: 1245.31.86012 Boehringer Ingelheim Investigational Site
city: Haerbin
country: China
facility: 1245.31.86037 Boehringer Ingelheim Investigational Site
city: Hangzhou
country: China
facility: 1245.31.86020 Boehringer Ingelheim Investigational Site
city: Jinan
country: China
facility: 1245.31.86049 Boehringer Ingelheim Investigational Site
city: Jinan
country: China
facility: 1245.31.86053 Boehringer Ingelheim Investigational Site
city: Jingzhou
country: China
facility: 1245.31.86018 Boehringer Ingelheim Investigational Site
city: Nan Ning
country: China
facility: 1245.31.86055 Boehringer Ingelheim Investigational Site
city: Nan Ning
country: China
facility: 1245.31.86056 Boehringer Ingelheim Investigational Site
city: Nanchang
country: China
facility: 1245.31.86019 Boehringer Ingelheim Investigational Site
city: Nanjing
country: China
facility: 1245.31.86042 Boehringer Ingelheim Investigational Site
city: Nanjing
country: China
facility: 1245.31.86043 Boehringer Ingelheim Investigational Site
city: QingDao
country: China
facility: 1245.31.86016 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 1245.31.86039 Boehringer Ingelheim Investigational Site
city: Shantou
country: China
facility: 1245.31.86054 Boehringer Ingelheim Investigational Site
city: Shenyang
country: China
facility: 1245.31.86057 Boehringer Ingelheim Investigational Site
city: Shijiazhuang
country: China
facility: 1245.31.86045 Boehringer Ingelheim Investigational Site
city: Shiyan
country: China
facility: 1245.31.86017 Boehringer Ingelheim Investigational Site
city: Suzhou
country: China
facility: 1245.31.86013 Boehringer Ingelheim Investigational Site
city: Taiyuan
country: China
facility: 1245.31.86015 Boehringer Ingelheim Investigational Site
city: Tianjin
country: China
facility: 1245.31.86036 Boehringer Ingelheim Investigational Site
city: Xi'An
country: China
facility: 1245.31.86011 Boehringer Ingelheim Investigational Site
city: Xi'An
country: China
facility: 1245.31.86041 Boehringer Ingelheim Investigational Site
city: Xiamen
country: China
facility: 1245.31.86014 Boehringer Ingelheim Investigational Site
city: Bersée
country: France
facility: 1245.31.33008 Boehringer Ingelheim Investigational Site
city: Bischheim
country: France
facility: 1245.31.33020 Boehringer Ingelheim Investigational Site
city: Bondy Cedex
country: France
facility: 1245.31.33002 Boehringer Ingelheim Investigational Site
city: Bruay La Buissiere
country: France
facility: 1245.31.33016 Boehringer Ingelheim Investigational Site
city: Corbeil Essonnes
country: France
facility: 1245.31.33001 Boehringer Ingelheim Investigational Site
city: Croix
country: France
facility: 1245.31.33010 Boehringer Ingelheim Investigational Site
city: Hautmont
country: France
facility: 1245.31.33009 Boehringer Ingelheim Investigational Site
city: La Rochelle Cedex 1
country: France
facility: 1245.31.33003 Boehringer Ingelheim Investigational Site
city: Marseille
country: France
facility: 1245.31.33045 Boehringer Ingelheim Investigational Site
city: Narbonne Cedex
country: France
facility: 1245.31.33004 Boehringer Ingelheim Investigational Site
city: Schiltigheim
country: France
facility: 1245.31.33012 Boehringer Ingelheim Investigational Site
city: Strasbourg
country: France
facility: 1245.31.33013 Boehringer Ingelheim Investigational Site
city: Strasbourg
country: France
facility: 1245.31.33019 Boehringer Ingelheim Investigational Site
city: Vieux Condé
country: France
facility: 1245.31.33007 Boehringer Ingelheim Investigational Site
city: Wattrelos
country: France
facility: 1245.31.33018 Boehringer Ingelheim Investigational Site
city: Dormagen
country: Germany
facility: 1245.31.49001 Boehringer Ingelheim Investigational Site
city: Dresden
country: Germany
facility: 1245.31.49013 Boehringer Ingelheim Investigational Site
city: Düsseldorf
country: Germany
facility: 1245.31.49016 Boehringer Ingelheim Investigational Site
city: Flörsheim
country: Germany
facility: 1245.31.49009 Boehringer Ingelheim Investigational Site
city: Frankfurt
country: Germany
facility: 1245.31.49015 Boehringer Ingelheim Investigational Site
city: Haag
country: Germany
facility: 1245.31.49019 Boehringer Ingelheim Investigational Site
city: Hatten
country: Germany
facility: 1245.31.49004 Boehringer Ingelheim Investigational Site
city: Hohenmölsen
country: Germany
facility: 1245.31.49020 Boehringer Ingelheim Investigational Site
city: Künzing
country: Germany
facility: 1245.31.49007 Boehringer Ingelheim Investigational Site
city: Neuwied
country: Germany
facility: 1245.31.49002 Boehringer Ingelheim Investigational Site
city: Nürnberg
country: Germany
facility: 1245.31.49008 Boehringer Ingelheim Investigational Site
city: Rednitzhembach
country: Germany
facility: 1245.31.49010 Boehringer Ingelheim Investigational Site
city: Rehburg-Loccum
country: Germany
facility: 1245.31.49006 Boehringer Ingelheim Investigational Site
city: Rehlingen-Siersburg
country: Germany
facility: 1245.31.49011 Boehringer Ingelheim Investigational Site
city: Saarbrücken
country: Germany
facility: 1245.31.49005 Boehringer Ingelheim Investigational Site
city: Schauenburg
country: Germany
facility: 1245.31.49022 Boehringer Ingelheim Investigational Site
city: St. Ingbert/Oberwürzbach
country: Germany
facility: 1245.31.49017 Boehringer Ingelheim Investigational Site
city: Unterschneidheim
country: Germany
facility: 1245.31.49003 Boehringer Ingelheim Investigational Site
city: Thessaloniki
country: Greece
facility: 1245.31.30004 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 1245.31.91005 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 1245.31.91006 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 1245.31.91008 Boehringer Ingelheim Investigational Site
city: Belgaum
country: India
facility: 1245.31.91003 Boehringer Ingelheim Investigational Site
city: Chennai
country: India
facility: 1245.31.91004 Boehringer Ingelheim Investigational Site
city: Chennai
country: India
facility: 1245.31.91009 Boehringer Ingelheim Investigational Site
city: Coimbatore
country: India
facility: 1245.31.91001 Boehringer Ingelheim Investigational Site
city: Coimbatore
country: India
facility: 1245.31.91101 Boehringer Ingelheim Investigational Site
city: Gulbarga
country: India
facility: 1245.31.91015 Boehringer Ingelheim Investigational Site
city: Indore
country: India
facility: 1245.31.91104 Boehringer Ingelheim Investigational Site
city: Maharashtra
country: India
facility: 1245.31.91103 Boehringer Ingelheim Investigational Site
city: Mumbai, Maharastra
country: India
facility: 1245.31.91007 Boehringer Ingelheim Investigational Site
city: Mumbai
country: India
facility: 1245.31.91002 Boehringer Ingelheim Investigational Site
city: Nagpur
country: India
facility: 1245.31.91010 Boehringer Ingelheim Investigational Site
city: New Delhi
country: India
facility: 1245.31.91012 Boehringer Ingelheim Investigational Site
city: Pune
country: India
facility: 1245.31.91014 Boehringer Ingelheim Investigational Site
city: Pune
country: India
facility: 1245.31.91105 Boehringer Ingelheim Investigational Site
city: Birr, Co. Offaly
country: Ireland
facility: 1245.31.35304 Boehringer Ingelheim Investigational Site
city: Co. Cork
country: Ireland
facility: 1245.31.35302 Boehringer Ingelheim Investigational Site
city: Co. Galway
country: Ireland
facility: 1245.31.35305 Boehringer Ingelheim Investigational Site
city: Co. Wexford
country: Ireland
facility: 1245.31.35303 Boehringer Ingelheim Investigational Site
city: Co. Wexford
country: Ireland
facility: 1245.31.35306 Boehringer Ingelheim Investigational Site
city: Chiyoda-ku, Tokyo
country: Japan
facility: 1245.31.81007 Boehringer Ingelheim Investigational Site
city: Chuo-ku, Tokyo
country: Japan
facility: 1245.31.81001 Boehringer Ingelheim Investigational Site
city: Chuo-ku, Tokyo
country: Japan
facility: 1245.31.81002 Boehringer Ingelheim Investigational Site
city: Ebetsu, Hokkaido
country: Japan
facility: 1245.31.81005 Boehringer Ingelheim Investigational Site
city: Kamakura, Kanagawa
country: Japan
facility: 1245.31.81004 Boehringer Ingelheim Investigational Site
city: Minato-ku, Tokyo
country: Japan
facility: 1245.31.81003 Boehringer Ingelheim Investigational Site
city: Shinjuku-ku, Tokyo
country: Japan
facility: 1245.31.81006 Boehringer Ingelheim Investigational Site
city: Shinjuku-ku, Tokyo
country: Japan
facility: 1245.31.81008 Boehringer Ingelheim Investigational Site
city: Suita, Osaka
country: Japan
facility: 1245.31.81009 Boehringer Ingelheim Investigational Site
city: Ube, Yamaguchi
country: Japan
facility: 1245.31.81010 Boehringer Ingelheim Investigational Site
city: Urasoe, Okinawa
country: Japan
facility: 1245.31.81012 Boehringer Ingelheim Investigational Site
city: Urasoe, Okinawa
country: Japan
facility: 1245.31.81013 Boehringer Ingelheim Investigational Site
city: Anyang
country: Korea, Republic of
facility: 1245.31.82012 Boehringer Ingelheim Investigational Site
city: Goyang
country: Korea, Republic of
facility: 1245.31.82011 Boehringer Ingelheim Investigational Site
city: Ilsan
country: Korea, Republic of
facility: 1245.31.82009 Boehringer Ingelheim Investigational Site
city: Incheon
country: Korea, Republic of
facility: 1245.31.82001 Boehringer Ingelheim Investigational Site
city: Jeonju
country: Korea, Republic of
facility: 1245.31.82006 Boehringer Ingelheim Investigational Site
city: Pusan
country: Korea, Republic of
facility: 1245.31.82004 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1245.31.82005 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1245.31.82007 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1245.31.82008 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1245.31.82010 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1245.31.82014 Boehringer Ingelheim Investigational Site
city: Suwon
country: Korea, Republic of
facility: 1245.31.82002 Boehringer Ingelheim Investigational Site
city: Wonju
country: Korea, Republic of
facility: 1245.31.82003 Boehringer Ingelheim Investigational Site
city: Guadalajara
country: Mexico
facility: 1245.31.52003 Boehringer Ingelheim Investigational Site
city: Guadalajara
country: Mexico
facility: 1245.31.52004 Boehringer Ingelheim Investigational Site
city: Monterrey
country: Mexico
facility: 1245.31.52001 Boehringer Ingelheim Investigational Site
city: Monterrey
country: Mexico
facility: 1245.31.52002 Boehringer Ingelheim Investigational Site
city: Cebu
country: Philippines
facility: 1245.31.63002 Boehringer Ingelheim Investigational Site
city: Davao City
country: Philippines
facility: 1245.31.63003 Boehringer Ingelheim Investigational Site
city: Manila
country: Philippines
facility: 1245.31.63001 Boehringer Ingelheim Investigational Site
city: Manila
country: Philippines
facility: 1245.31.63004 Boehringer Ingelheim Investigational Site
city: Manila
country: Philippines
facility: 1245.31.63005 Boehringer Ingelheim Investigational Site
city: Bratislava
country: Slovakia
facility: 1245.31.74005 Boehringer Ingelheim Investigational Site
city: Lucenec
country: Slovakia
facility: 1245.31.74002 Boehringer Ingelheim Investigational Site
city: Nitra
country: Slovakia
facility: 1245.31.74006 Boehringer Ingelheim Investigational Site
city: Nove Zamky
country: Slovakia
facility: 1245.31.74014 Boehringer Ingelheim Investigational Site
city: Povazska Bystrica
country: Slovakia
facility: 1245.31.74001 Boehringer Ingelheim Investigational Site
city: Presov
country: Slovakia
facility: 1245.31.74004 Boehringer Ingelheim Investigational Site
city: Trebisov
country: Slovakia
facility: 1245.31.74003 Boehringer Ingelheim Investigational Site
city: Celje
country: Slovenia
facility: 1245.31.38003 Boehringer Ingelheim Investigational Site
city: Koper
country: Slovenia
facility: 1245.31.38002 Boehringer Ingelheim Investigational Site
city: Maribor
country: Slovenia
facility: 1245.31.38001 Boehringer Ingelheim Investigational Site
city: Lugano
country: Switzerland
facility: 1245.31.41004 Boehringer Ingelheim Investigational Site
city: Rorschach
country: Switzerland
facility: 1245.31.41003 Boehringer Ingelheim Investigational Site
city: Kaohsiung
country: Taiwan
facility: 1245.31.88010 Boehringer Ingelheim Investigational Site
city: Kaohsiung
country: Taiwan
facility: 1245.31.88011 Boehringer Ingelheim Investigational Site
city: Kaohsiung
country: Taiwan
facility: 1245.31.88012 Boehringer Ingelheim Investigational Site
city: Kaohsiung
country: Taiwan
facility: 1245.31.88013 Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: 1245.31.88009 Boehringer Ingelheim Investigational Site
city: Tainan
country: Taiwan
facility: 1245.31.88014 Boehringer Ingelheim Investigational Site
city: Taipei
country: Taiwan
facility: 1245.31.88006 Boehringer Ingelheim Investigational Site
city: Taipei
country: Taiwan
facility: 1245.31.88021 Boehringer Ingelheim Investigational Site
city: Taoyuan County
country: Taiwan
facility: 1245.31.88008 Boehringer Ingelheim Investigational Site
city: Erzurum
country: Turkey
facility: 1245.31.90003 Boehringer Ingelheim Investigational Site
city: Gaziantep
country: Turkey
facility: 1245.31.90001 Boehringer Ingelheim Investigational Site
city: Istanbul
country: Turkey
facility: 1245.31.90002 Boehringer Ingelheim Investigational Site
city: Istanbul
country: Turkey
facility: 1245.31.90006 Boehringer Ingelheim Investigational Site
city: Izmir
country: Turkey
facility: 1245.31.90004 Boehringer Ingelheim Investigational Site
city: Dnepropetrovsk
country: Ukraine
facility: 1245.31.75002 Boehringer Ingelheim Investigational Site
city: Kharkiv
country: Ukraine
facility: 1245.31.75001 Boehringer Ingelheim Investigational Site
city: Lviv
country: Ukraine
facility: 1245.31.75006 Boehringer Ingelheim Investigational Site
city: Vinnitsa
country: Ukraine
facility: 1245.31.75004 Boehringer Ingelheim Investigational Site
city: Vinnytsya
country: Ukraine
facility: 1245.31.75003 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.
citation: Inzucchi SE, Davies MJ, Khunti K, Trivedi P, George JT, Zwiener I, Johansen OE, Sattar N. Empagliflozin treatment effects across categories of baseline HbA1c, body weight and blood pressure as an add-on to metformin in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Feb;23(2):425-433. doi: 10.1111/dom.14234. Epub 2020 Nov 20.
citation: Shiba T, Ishii S, Okamura T, Mitsuyoshi R, Pfarr E, Koiwai K. Efficacy and safety of empagliflozin in Japanese patients with type 2 diabetes mellitus: A sub-analysis by body mass index and age of pooled data from three clinical trials. Diabetes Res Clin Pract. 2017 Sep;131:169-178. doi: 10.1016/j.diabres.2017.07.004. Epub 2017 Jul 8.
citation: Roden M, Merker L, Christiansen AV, Roux F, Salsali A, Kim G, Stella P, Woerle HJ, Broedl UC; EMPA-REG EXTEND MONO investigators. Safety, tolerability and effects on cardiometabolic risk factors of empagliflozin monotherapy in drug-naive patients with type 2 diabetes: a double-blind extension of a Phase III randomized controlled trial. Cardiovasc Diabetol. 2015 Dec 23;14:154. doi: 10.1186/s12933-015-0314-0.
citation: Haering HU, Merker L, Christiansen AV, Roux F, Salsali A, Kim G, Meinicke T, Woerle HJ, Broedl UC; EMPA-REG EXTEND METSU investigators. Empagliflozin as add-on to metformin plus sulphonylurea in patients with type 2 diabetes. Diabetes Res Clin Pract. 2015 Oct;110(1):82-90. doi: 10.1016/j.diabres.2015.05.044. Epub 2015 May 29.