Clinical trial NCT00736099: Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM
Official title: A 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 1356 (5 mg) as Monotherapy or in Combination With Other Antidiabetic Medications in Type 2 Diabetic Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-08-15
Enrollment: 2122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the current study is to investigate the safety and tolerability of BI 1356 (5 mg / once daily) given for 78 weeks in different modalities of treatment.

The treatment modalities are determined by the treatment in the blinded trial in which every patient was included previously as BI 1356 in monotherapy (patients in 1218.16 trial), BI 1356 in combination with pioglitazone (patients in 1218.15 trial), BI 1356 added to metformin background (patients in 1218.17 trial) or BI 1356 added to a background therapy of metformin in combination with a sulphonylurea (patients in 1218.18 study)


Eligibility criteria: Inclusion criteria:

1. Signed and dated written informed consent in accordance with the GCP and local legislation.
2. Patients completing the entire treatment period as a double blind trial whether or not they have been treated with rescue medication.

Exclusion criteria:

1. Patients who meet one or more of the withdrawal criteria of the treatment period of the previous trial.
2. Pre-menopausal women (last menstruation =\< 1 year prior to signing 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 transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, true sexual abstinence (when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence \[e.g. calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of birth control) and vasectomised partners. No exception will be made.
3. Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation.
4. Drug abuse which, in the opinion of the investigator, would interfere with trial participation.
5. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication.

Primary outcomes:
measure: Frequency of Patients With Adverse Events (AEs)
timeFrame: 78 weeks
measure: Frequency of Patients With Investigator-defined Hypoglycaemic Adverse Events
timeFrame: 78 weeks
measure: Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ)
timeFrame: 78 weeks
measure: Frequency of Patients With Adjudication of Cardiac and Cerebrovascular Events
timeFrame: 78 weeks
measure: Number of Patients With Abnormalities in Vital Signs
timeFrame: 78 weeks
measure: Number of Patients With Abnormalities in Haematology: Eosinophils
timeFrame: 78 weeks
measure: Number of Patients With Abnormalities in Haematology: Haemoglobin
timeFrame: 78 weeks
measure: Number of Patients With Abnormalities in Haematology: Haematocrit
timeFrame: 78 weeks
measure: Number of Patients With Abnormalities in Haematology: Red Blood Cell Count
timeFrame: 78 weeks
measure: Number of Patients With Abnormalities in Haematology: White Blood Cell Count
timeFrame: 78 weeks
measure: Number of Patients With Abnormalities in Haematology: Platelets
timeFrame: 78 weeks
measure: Number of Patients With Abnormalities in Clinical Chemistry: Potassium
timeFrame: 78 weeks
measure: Number of Patients With Abnormalities in Clinical Chemistry: Uric Acid
timeFrame: 78 weeks
measure: Number of Patients With Abnormalities in Clinical Chemistry: Triglycerides
timeFrame: 78 weeks
measure: Number of Patients With Abnormalities in Clinical Chemistry: Amylase
timeFrame: 78 weeks
measure: Number of Patients With Abnormalities in Clinical Chemistry: γ-Glutamyl-transferase (GGT)
timeFrame: 78 weeks
measure: Number of Patients With Abnormalities in Clinical Chemistry: Creatinine
timeFrame: 78 weeks
measure: Number of Patients With Abnormalities in Clinical Chemistry: Creatinine Kinase
timeFrame: 78 weeks
measure: Number of Patients With Abnormalities in Clinical Chemistry: Phosphate
timeFrame: 78 weeks
measure: Number of Patients With Abnormalities in Clinical Chemistry: Calcium
timeFrame: 78 weeks
measure: Number of Patients With Abnormalities in Clinical Chemistry: Sodium
timeFrame: 78 weeks
measure: Number of Patients With Abnormalities in Clinical Chemistry: Alanine Transaminase (ALT)
timeFrame: 78 weeks
measure: Number of Patients With Abnormalities in Clinical Chemistry: Aspartate Transaminase (AST)
timeFrame: 78 weeks
measure: Number of Patients With Abnormalities in Clinical Chemistry: Glucose
timeFrame: 78 weeks
measure: Number of Patients With Abnormalities in Clinical Chemistry: Bilirubin
timeFrame: 78 weeks
measure: Number of Patients With Abnormalities in Clinical Chemistry: Alkaline Phosphatase (AP)
timeFrame: 78 weeks
measure: Number of Patients With Abnormalities in Clinical Chemistry: Albumin
timeFrame: 78 weeks
measure: Number of Patients With Abnormalities in Clinical Chemistry: Lactate Dehydrogenase (LDH)
timeFrame: 78 weeks
measure: Number of Patients With Abnormalities in Clinical Chemistry: Cholesterol
timeFrame: 78 weeks
Secondary outcomes:
measure: Change in HbA1c From Baseline to Week 6
timeFrame: Baseline and week 6
measure: Change in HbA1c From Baseline to Week 18
timeFrame: Baseline and week 18
measure: Change in HbA1c From Baseline to Week 30
timeFrame: Baseline and week 30
measure: Change in HbA1c From Baseline to Week 42
timeFrame: Baseline and week 42
measure: Change in HbA1c From Baseline to Week 54
timeFrame: Baseline and week 54
measure: Change in HbA1c From Baseline to Week 66
timeFrame: Baseline and week 66
measure: Change in HbA1c From Baseline to Week 78
timeFrame: Baseline and week 78
measure: Number of Patients With HbA1c<7.0% Over Time
timeFrame: 78 weeks
measure: Number of Patients With HbA1c<6.5% Over Time
timeFrame: 78 weeks
measure: Number of Patients With Lowered HbA1c by at Least 0.5% Over Time
timeFrame: 78 weeks
measure: Change in FPG From Baseline to Week 6
timeFrame: Baseline and week 6
measure: Change in FPG From Baseline to Week 18
timeFrame: Baseline and week 18
measure: Change in FPG From Baseline to Week 30
timeFrame: Baseline and week 30
measure: Change in FPG From Baseline to Week 42
timeFrame: Baseline and week 42
measure: Change in FPG From Baseline to Week 54
timeFrame: Baseline and week 54
measure: Change in FPG From Baseline to Week 66
timeFrame: Baseline and week 66
measure: Change in FPG From Baseline to Week 78
timeFrame: Baseline and week 78
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: 1218.40.10003 Boehringer Ingelheim Investigational Site
state: California
city: Spring Valley
country: United States
facility: 1218.40.10014 Boehringer Ingelheim Investigational Site
state: California
city: Walnut Creek
country: United States
facility: 1218.40.10001 Boehringer Ingelheim Investigational Site
state: California
city: Northglenn
country: United States
facility: 1218.40.10021 Boehringer Ingelheim Investigational Site
state: Colorado
city: Hollywood
country: United States
facility: 1218.40.10010 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: 1218.40.10011 Boehringer Ingelheim Investigational Site
state: Florida
city: Eugene
country: United States
facility: 1218.40.10016 Boehringer Ingelheim Investigational Site
state: Oregon
city: Greer
country: United States
facility: 1218.40.10002 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Simpsonville
country: United States
facility: 1218.40.10004 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Dallas
country: United States
facility: 1218.40.10005 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1218.40.10018 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 1218.40.10007 Boehringer Ingelheim Investigational Site
state: Texas
city: Federal Way
country: United States
facility: 1218.40.10009 Boehringer Ingelheim Investigational Site
state: Washington
city: Capital Federal
country: Argentina
facility: 1218.40.54002 Boehringer Ingelheim Investigational Site
city: Capital Federal
country: Argentina
facility: 1218.40.54010 Boehringer Ingelheim Investigational Site
city: Mendoza
country: Argentina
facility: 1218.40.54011 Boehringer Ingelheim Investigational Site
city: Parque Velez Sarfield
country: Argentina
facility: 1218.40.54015 Boehringer Ingelheim Investigational Site
city: Graz
country: Austria
facility: 1218.40.43001 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1218.40.43005 Boehringer Ingelheim Investigational Site
city: Brugge
country: Belgium
facility: 1218.40.32005 Boehringer Ingelheim Investigational Site
city: Brussel
country: Belgium
facility: 1218.40.32007 Boehringer Ingelheim Investigational Site
city: Edegem
country: Belgium
facility: 1218.40.32006 Boehringer Ingelheim Investigational Site
city: Genk
country: Belgium
facility: 1218.40.32004 Boehringer Ingelheim Investigational Site
city: Gent
country: Belgium
facility: 1218.40.32003 Boehringer Ingelheim Investigational Site
city: Huy
country: Belgium
facility: 1218.40.32002 Boehringer Ingelheim Investigational Site
city: Liège
country: Belgium
facility: 1218.40.32001 Boehringer Ingelheim Investigational Site
city: Calgary
country: Canada
facility: 1218.40.01005 Boehringer Ingelheim Investigational Site
state: Alberta
city: Calgary
country: Canada
facility: 1218.40.01010 Boehringer Ingelheim Investigational Site
state: Alberta
city: Vancouver
country: Canada
facility: 1218.40.01003 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: 1218.40.01011 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Etobicoke
country: Canada
facility: 1218.40.01006 Boehringer Ingelheim Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: 1218.40.01009 Boehringer Ingelheim Investigational Site
state: Ontario
city: London
country: Canada
facility: 1218.40.01002 Boehringer Ingelheim Investigational Site
state: Ontario
city: Oakville
country: Canada
facility: 1218.40.01012 Boehringer Ingelheim Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: 1218.40.01008 Boehringer Ingelheim Investigational Site
state: Ontario
city: Strathroy
country: Canada
facility: 1218.40.20005 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 1218.40.01001 Boehringer Ingelheim Investigational Site
state: Ontario
city: Montague
country: Canada
facility: 1218.40.01004 Boehringer Ingelheim Investigational Site
state: Prince Edward Island
city: Saskatoon
country: Canada
facility: 1218.40.01007 Boehringer Ingelheim Investigational Site
state: Saskatchewan
city: Beijing
country: China
facility: 1218.40.86001 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 1218.40.86002 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 1218.40.86004 Boehringer Ingelheim Investigational Site
city: Chengdu
country: China
facility: 1218.40.86013 Boehringer Ingelheim Investigational Site
city: Dalian
country: China
facility: 1218.40.86009 Boehringer Ingelheim Investigational Site
city: Guangzhou
country: China
facility: 1218.40.86011 Boehringer Ingelheim Investigational Site
city: Haerbin
country: China
facility: 1218.40.86014 Boehringer Ingelheim Investigational Site
city: Qingdao
country: China
facility: 1218.40.86008 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 1218.40.86015 Boehringer Ingelheim Investigational Site
city: Shenyang
country: China
facility: 1218.40.86010 Boehringer Ingelheim Investigational Site
city: Wuhan
country: China
facility: 1218.40.86007 Boehringer Ingelheim Investigational Site
city: Wuhan
country: China
facility: 1218.40.86012 Boehringer Ingelheim Investigational Site
city: Xi'An
country: China
facility: 1218.40.86006 Boehringer Ingelheim Investigational Site
city: Krapinske Toplice
country: Croatia
facility: 1218.40.38605 Boehringer Ingelheim Investigational Site
city: Slavonski Brod
country: Croatia
facility: 1218.40.38604 Boehringer Ingelheim Investigational Site
city: Breclav
country: Czech Republic
facility: 1218.40.42006 Boehringer Ingelheim Investigational Site
city: Brno
country: Czech Republic
facility: 1218.40.42004 Boehringer Ingelheim Investigational Site
city: Brno
country: Czech Republic
facility: 1218.40.42007 Boehringer Ingelheim Investigational Site
city: Brno
country: Czech Republic
facility: 1218.40.42009 Boehringer Ingelheim Investigational Site
city: Hodonin
country: Czech Republic
facility: 1218.40.42008 Boehringer Ingelheim Investigational Site
city: Olomouc
country: Czech Republic
facility: 1218.40.42003 Boehringer Ingelheim Investigational Site
city: Helsinki
country: Finland
facility: 1218.40.35806 Boehringer Ingelheim Investigational Site
city: Kuopio
country: Finland
facility: 1218.40.35801 Boehringer Ingelheim Investigational Site
city: Oulu
country: Finland
facility: 1218.40.35803 Boehringer Ingelheim Investigational Site
city: Seinäjoki
country: Finland
facility: 1218.40.35805 Boehringer Ingelheim Investigational Site
city: Turku
country: Finland
facility: 1218.40.35802 Boehringer Ingelheim Investigational Site
city: Bad Mergentheim
country: Germany
facility: 1218.40.49028 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1218.40.49022 Boehringer Ingelheim Investigational Site
city: Bosenheim
country: Germany
facility: 1218.40.49024 Boehringer Ingelheim Investigational Site
city: Dresden
country: Germany
facility: 1218.40.49020 Boehringer Ingelheim Investigational Site
city: Mainz
country: Germany
facility: 1218.40.49101 Boehringer Ingelheim Investigational Site
city: Neuwied
country: Germany
facility: 1218.40.49003 Boehringer Ingelheim Investigational Site
city: Nürnberg
country: Germany
facility: 1218.40.49007 Boehringer Ingelheim Investigational Site
city: Saarbrücken
country: Germany
facility: 1218.40.49014 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1218.40.30004 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1218.40.30007 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1218.40.30013 Boehringer Ingelheim Investigational Site
city: Nikaia
country: Greece
facility: 1218.40.30003 Boehringer Ingelheim Investigational Site
city: Piraeus
country: Greece
facility: 1218.40.30011 Boehringer Ingelheim Investigational Site
city: Thessaloniki
country: Greece
facility: 1218.40.30006 Boehringer Ingelheim Investigational Site
city: Thessaloniki
country: Greece
facility: 1218.40.30016 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 1218.40.36003 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 1218.40.36004 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 1218.40.36006 Boehringer Ingelheim Investigational Site
city: Debrecen
country: Hungary
facility: 1218.40.36008 Boehringer Ingelheim Investigational Site
city: Györ
country: Hungary
facility: 1218.40.36005 Boehringer Ingelheim Investigational Site
city: Szombathely
country: Hungary
facility: 1218.40.36002 Boehringer Ingelheim Investigational Site
city: Andhra Pradesh
country: India
facility: 1218.40.91010 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 1218.40.91002 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 1218.40.91005 Boehringer Ingelheim Investigational Site
city: Chennai
country: India
facility: 1218.40.91012 Boehringer Ingelheim Investigational Site
city: Chennai
country: India
facility: 1218.40.91014 Boehringer Ingelheim Investigational Site
city: Hyderabad, Andra Pradesh
country: India
facility: 1218.40.91009 Boehringer Ingelheim Investigational Site
city: Jaipur
country: India
facility: 1218.40.91006 Boehringer Ingelheim Investigational Site
city: Kerala
country: India
facility: 1218.40.91001 Boehringer Ingelheim Investigational Site
city: Maharashtra
country: India
facility: 1218.40.91011 Boehringer Ingelheim Investigational Site
city: Mangalore
country: India
facility: 1218.40.91008 Boehringer Ingelheim Investigational Site
city: Manipal
country: India
facility: 1218.40.91007 Boehringer Ingelheim Investigational Site
city: Mumbai
country: India
facility: 1218.40.91004 Boehringer Ingelheim Investigational Site
city: Nasik
country: India
facility: 1218.40.91003 Boehringer Ingelheim Investigational Site
city: Uttar Pradesh
country: India
facility: 1218.40.91013 Boehringer Ingelheim Investigational Site
city: Afula
country: Israel
facility: 1218.40.97274 Boehringer Ingelheim Investigational Site
city: Haifa
country: Israel
facility: 1218.40.97273 Boehringer Ingelheim Investigational Site
city: Holon
country: Israel
facility: 1218.40.97275 Boehringer Ingelheim Investigational Site
city: Jerusalem
country: Israel
facility: 1218.40.97271 Boehringer Ingelheim Investigational Site
city: Nahariya
country: Israel
facility: 1218.40.97272 Boehringer Ingelheim Investigational Site
city: Safed
country: Israel
facility: 1218.40.97276 Boehringer Ingelheim Investigational Site
city: Tel Aviv
country: Israel
facility: 1218.40.97278 Boehringer Ingelheim Investigational Site
city: Genova
country: Italy
facility: 1218.40.39008 Boehringer Ingelheim Investigational Site
city: Milano
country: Italy
facility: 1218.40.39002 Boehringer Ingelheim Investigational Site
city: Pisa
country: Italy
facility: 1218.40.39001 Boehringer Ingelheim Investigational Site
city: Roma
country: Italy
facility: 1218.40.39006 Boehringer Ingelheim Investigational Site
city: Amagasaki, Hyogo
country: Japan
facility: 1218.40.81001 Boehringer Ingelheim Investigational Site
city: Koganei, Tokyo
country: Japan
facility: 1218.40.81005 Boehringer Ingelheim Investigational Site
city: Osaka, Osaka
country: Japan
facility: 1218.40.81002 Boehringer Ingelheim Investigational Site
city: Shinjyuku-ku,Tokyo
country: Japan
facility: 1218.40.81004 Boehringer Ingelheim Investigational Site
city: Suita, Osaka,
country: Japan
facility: 1218.40.81003 Boehringer Ingelheim Investigational Site
city: Busan
country: Korea, Republic of
facility: 1218.40.82002 Boehringer Ingelheim Investigational Site
city: Daegu
country: Korea, Republic of
facility: 1218.40.82011 Boehringer Ingelheim Investigational Site
city: Incheon
country: Korea, Republic of
facility: 1218.40.82008 Boehringer Ingelheim Investigational Site
city: Jeonju
country: Korea, Republic of
facility: 1218.40.82010 Boehringer Ingelheim Investigational Site
city: Pusan
country: Korea, Republic of
facility: 1218.40.82004 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1218.40.82001 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1218.40.82005 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1218.40.82006 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1218.40.82007 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1218.40.82009 Boehringer Ingelheim Investigational Site
city: Suwon
country: Korea, Republic of
facility: 1218.40.82003 Boehringer Ingelheim Investigational Site
city: Kelantan
country: Malaysia
facility: 1218.40.60003 Boehringer Ingelheim Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: 1218.40.60001 Boehringer Ingelheim Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: 1218.40.60002 Boehringer Ingelheim Investigational Site
city: Penang
country: Malaysia
facility: 1218.40.60007 Boehringer Ingelheim Investigational Site
city: Perak
country: Malaysia
facility: 1218.40.60004 Boehringer Ingelheim Investigational Site
city: Perak
country: Malaysia
facility: 1218.40.60005 Boehringer Ingelheim Investigational Site
city: Aguascalientes, Ags.
country: Mexico
facility: 1218.40.52007 Boehringer Ingelheim Investigational Site
city: Col.Americana, Guadalajara, Jalisco
country: Mexico
facility: 1218.40.52010 Boehringer Ingelheim Investigational Site
city: Colonia Tlalpan, mexico
country: Mexico
facility: 1218.40.52008 Boehringer Ingelheim Investigational Site
city: Faccionamiento Lomas de Campestre,AGUASCAL
country: Mexico
facility: 1218.40.52006 Boehringer Ingelheim Investigational Site
city: León
country: Mexico
facility: 1218.40.52009 Boehringer Ingelheim Investigational Site
city: Monterrey N.L.
country: Mexico
facility: 1218.40.52001 Boehringer Ingelheim Investigational Site
city: Monterrey
country: Mexico
facility: 1218.40.52003 Boehringer Ingelheim Investigational Site
city: México
country: Mexico
facility: 1218.40.52002 Boehringer Ingelheim Investigational Site
city: México
country: Mexico
facility: 1218.40.52004 Boehringer Ingelheim Investigational Site
city: México
country: Mexico
facility: 1218.40.52005 Boehringer Ingelheim Investigational Site
city: Deurne
country: Netherlands
facility: 1218.40.31006 Boehringer Ingelheim Investigational Site
city: Ewijk
country: Netherlands
facility: 1218.40.31001 Boehringer Ingelheim Investigational Site
city: Losser
country: Netherlands
facility: 1218.40.31010 Boehringer Ingelheim Investigational Site
city: Roelofarendsveen
country: Netherlands
facility: 1218.40.31008 Boehringer Ingelheim Investigational Site
city: Wildervank
country: Netherlands
facility: 1218.40.31002 Boehringer Ingelheim Investigational Site
city: Christchurch
country: New Zealand
facility: 1218.40.64004 Boehringer Ingelheim Investigational Site
city: Dunedin
country: New Zealand
facility: 1218.40.64003 Boehringer Ingelheim Investigational Site
city: Otahuhu
country: New Zealand
facility: 1218.40.64002 Boehringer Ingelheim Investigational Site
city: Tauranga
country: New Zealand
facility: 1218.40.64001 Boehringer Ingelheim Investigational Site
city: Wellington
country: New Zealand
facility: 1218.40.64005 Boehringer Ingelheim Investigational Site
city: Greenhills, San Juan
country: Philippines
facility: 1218.40.63003 Boehringer Ingelheim Investigational Site
city: Manila
country: Philippines
facility: 1218.40.63005 Boehringer Ingelheim Investigational Site
city: Marikina
country: Philippines
facility: 1218.40.63002 Boehringer Ingelheim Investigational Site
city: Pasig
country: Philippines
facility: 1218.40.63001 Boehringer Ingelheim Investigational Site
city: Quezon City
country: Philippines
facility: 1218.40.63004 Boehringer Ingelheim Investigational Site
city: Lublin
country: Poland
facility: 1218.40.48603 Boehringer Ingelheim Investigational Site
city: Warsaw
country: Poland
facility: 1218.40.48601 Boehringer Ingelheim Investigational Site
city: Zabrze
country: Poland
facility: 1218.40.48604 Boehringer Ingelheim Investigational Site
city: Alba Iulia
country: Romania
facility: 1218.40.40504 Boehringer Ingelheim Investigational Site
city: Brasov
country: Romania
facility: 1218.40.40604 Boehringer Ingelheim Investigational Site
city: Bucharest
country: Romania
facility: 1218.40.40501 Boehringer Ingelheim Investigational Site
city: Bucharest
country: Romania
facility: 1218.40.40502 Boehringer Ingelheim Investigational Site
city: Galati
country: Romania
facility: 1218.40.40603 Boehringer Ingelheim Investigational Site
city: Sibiu
country: Romania
facility: 1218.40.40503 Boehringer Ingelheim Investigational Site
city: Targu-Mures
country: Romania
facility: 1218.40.40505 Boehringer Ingelheim Investigational Site
city: Arkhangelsk
country: Russian Federation
facility: 1218.40.70014 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1218.40.70001 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1218.40.70002 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1218.40.70003 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1218.40.70012 Boehringer Ingelheim Investigational Site
city: Novosibirsk
country: Russian Federation
facility: 1218.40.70005 Boehringer Ingelheim Investigational Site
city: Perm
country: Russian Federation
facility: 1218.40.70006 Boehringer Ingelheim Investigational Site
city: Rostov-on-Don
country: Russian Federation
facility: 1218.40.70013 Boehringer Ingelheim Investigational Site
city: Samara
country: Russian Federation
facility: 1218.40.70016 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1218.40.70015 Boehringer Ingelheim Investigational Site
city: Tomsk
country: Russian Federation
facility: 1218.40.70004 Boehringer Ingelheim Investigational Site
city: Banska Bystrica
country: Slovakia
facility: 1218.40.42103 Boehringer Ingelheim Investigational Site
city: Bratislava
country: Slovakia
facility: 1218.40.42102 Boehringer Ingelheim Investigational Site
city: Bratislava
country: Slovakia
facility: 1218.40.42104 Boehringer Ingelheim Investigational Site
city: Bratislava
country: Slovakia
facility: 1218.40.42105 Boehringer Ingelheim Investigational Site
city: Nove Mesto
country: Slovakia
facility: 1218.40.42101 Boehringer Ingelheim Investigational Site
city: Samorin
country: Slovakia
facility: 1218.40.42106 Boehringer Ingelheim Investigational Site
city: Badalona
country: Spain
facility: 1218.40.34002 Boehringer Ingelheim Investigational Site
city: Badia del Vallés
country: Spain
facility: 1218.40.34011 Boehringer Ingelheim Investigational Site
city: Borges del Camp
country: Spain
facility: 1218.40.34012 Boehringer Ingelheim Investigational Site
city: Centelles
country: Spain
facility: 1218.40.34013 Boehringer Ingelheim Investigational Site
city: Granada
country: Spain
facility: 1218.40.34007 Boehringer Ingelheim Investigational Site
city: L'Hospitalet de Llobregat (Barcelona)
country: Spain
facility: 1218.40.34008 Boehringer Ingelheim Investigational Site
city: L'Hospitalet de Llobregat (Barcelona)
country: Spain
facility: 1218.40.34009 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1218.40.34004 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1218.40.34006 Boehringer Ingelheim Investigational Site
city: Sant Adrià del Besós (Barcelona)
country: Spain
facility: 1218.40.34010 Boehringer Ingelheim Investigational Site
city: Sevilla
country: Spain
facility: 1218.40.34005 Boehringer Ingelheim Investigational Site
city: Vic (Barcelona)
country: Spain
facility: 1218.40.34014 Boehringer Ingelheim Investigational Site
city: Härnösand
country: Sweden
facility: 1218.40.46013 Boehringer Ingelheim Investigational Site
city: Malmö
country: Sweden
facility: 1218.40.46001 Boehringer Ingelheim Investigational Site
city: Uddevalla
country: Sweden
facility: 1218.40.46012 Boehringer Ingelheim Investigational Site
city: Uppsala
country: Sweden
facility: 1218.40.46004 Boehringer Ingelheim Investigational Site
city: ChangHua
country: Taiwan
facility: 1218.40.88605 Boehringer Ingelheim Investigational Site
city: Taichung
country: Taiwan
facility: 1218.40.88604 Boehringer Ingelheim Investigational Site
city: Tainan
country: Taiwan
facility: 1218.40.88606 Boehringer Ingelheim Investigational Site
city: Taipei
country: Taiwan
facility: 1218.40.88601 Boehringer Ingelheim Investigational Site
city: Taipei
country: Taiwan
facility: 1218.40.88602 Boehringer Ingelheim Investigational Site
city: Taipei
country: Taiwan
facility: 1218.40.88603 Boehringer Ingelheim Investigational Site
city: Taipei
country: Taiwan
facility: 1218.40.88607 Boehringer Ingelheim Investigational Site
city: Taoyuan
country: Taiwan
facility: 1218.40.88608 Boehringer Ingelheim Investigational Site
city: Bangkok
country: Thailand
facility: 1218.40.66001 Boehringer Ingelheim Investigational Site
city: Khon Kaen
country: Thailand
facility: 1218.40.66002 Boehringer Ingelheim Investigational Site
city: Dnepropetrovsk
country: Ukraine
facility: 1218.40.38011 Boehringer Ingelheim Investigational Site
city: Kharkov
country: Ukraine
facility: 1218.40.38002 Boehringer Ingelheim Investigational Site
city: Kharkov
country: Ukraine
facility: 1218.40.38004 Boehringer Ingelheim Investigational Site
city: Kharkov
country: Ukraine
facility: 1218.40.38010 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1218.40.38001 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1218.40.38005 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1218.40.38008 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1218.40.38009 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1218.40.38012 Boehringer Ingelheim Investigational Site
city: Lvov
country: Ukraine
facility: 1218.40.38003 Boehringer Ingelheim Investigational Site
city: Vinnitsa
country: Ukraine
facility: 1218.40.38006 Boehringer Ingelheim Investigational Site
city: Zaporizhzhya
country: Ukraine
facility: 1218.40.38007 Boehringer Ingelheim Investigational Site
city: Ashford
country: United Kingdom
facility: 1218.40.44005 Boehringer Ingelheim Investigational Site
city: Baillieston, Glasgow
country: United Kingdom
facility: 1218.40.44004 Boehringer Ingelheim Investigational Site
city: Bath
country: United Kingdom
facility: 1218.40.44001 Boehringer Ingelheim Investigational Site
city: Burbage
country: United Kingdom
facility: 1218.40.44003 Boehringer Ingelheim Investigational Site
city: Bury St Edmonds
country: United Kingdom
facility: 1218.40.44010 Boehringer Ingelheim Investigational Site
city: Cardiff
country: United Kingdom
facility: 1218.40.44009 Boehringer Ingelheim Investigational Site
city: Penarth
country: United Kingdom
facility: 1218.40.44002 Boehringer Ingelheim Investigational Site
city: Reading
country: United Kingdom
facility: 1218.40.44006 Boehringer Ingelheim Investigational Site
city: Waterloo, Liverpool
country: United Kingdom
facility: 1218.40.44007 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: