Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM

Diabetes Mellitus, Type 2 Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00736099
• Other study ID #: 1218.40
• Secondary ID: 2008-000750-13
• Status: Completed
• Phase: Phase 3
• First received: August 14, 2008
• Last updated: June 18, 2014
• Start date: August 2008

Study information

• Verified date: December 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: A.N.M.A.T. (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica)Austria: Bundesamt für Sicherheit im Gesundheitswesen, A-1030 ViennaBelgium: Federal Agency for Medicines and Health Products, FAMHPCanada: Health Canada, Therapeutic Products DirectorateChina: Food and Drug AdministrationCroatia: Croatian Institute for Medicines Control, HR-10000 ZagrebCzech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10Finland: Finnish Medicines AgencyGermany: Bundesinstitut fuer Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger-Allee 3, D-53175 BonnGreat Britain: Medicines and Healthcare products Regulatory Agency (MHRA)Greece: National Organization of Medicines (EOF) National Ethics CommitteeHungary: National Institute of Pharmacy, H-1051 BudapestIndia: Drugs Controller General of IndiaIsrael: Ministry of HealthItaly: Comitato di Bioetica Azienda Ospedaliero - Universitaria Pisana - PISAJapan: Ministry of Health, Labor and WelfareKorea, Republic of: Korea Food and Drug AdministrationMalaysia: Drug Control AuthorityMexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS)Netherlands: Centrale Commissie Mensgebonden OnderzoekNew Zealand: Multi-Regional Ethics Committee / MedsafePhilippines: Bureau of Food and DrugsPoland: Registration Medicinal Product Medical Device Biocidal ProductRomania: National Medicines Agency, BucharestRussia: Ministry of Healthcare and Social Development of Russian Federation, MoscowSlovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26Spain: Agencia Espanola del Medicamento y Productos SanitariosSweden: Sweden; Läkemedelsverket (Medical Product Agency) Region Etics Committee of LundTaiwan: Department of Health, Executive Yuan, TaiwanThailand: Food and Drug AdministrationUkraine: Ministry of Health Care of Ukraine (MoH of Ukraine)United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2122
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 82 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• linagliptine 5 mg
safety and efficacy of linagliptine 5 mg open label
• linagliptine 5 mg and pioglitazone 30 mg
efficacy and safety of the combination linagliptine and pioglitazone

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  Canada,  China,  Croatia,  Czech Republic,  Finland,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Philippines,  Poland,  Romania,  Russian Federation,  Slovakia,  Spain,  Sweden,  Taiwan,  Thailand,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Patients With Adverse Events (AEs)	This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.	78 weeks	Yes
Primary	Frequency of Patients With Investigator-defined Hypoglycaemic Adverse Events		78 weeks	Yes
Primary	Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ)	As significant adverse events are considered: renal Aes (SMQ 'acute renal failure'), hypersensitivity reactions ('anaphylactic reactions' and 'angioedema'), hepatic Aes ('hepatitis, non-infectious', 'hepatic failure, fibrosis, cirrhosis and other liver damage-related conditions', 'liver-related investigations, signs and symptoms', 'cholestasis and jaundice of hepatic origin'), severe cutaneous adverse reactions ('severe cutaneous adverse reaction'), pancreatitis ('acute pancreatitis', 'chronic pancreatitis'').	78 weeks	Yes
Primary	Frequency of Patients With Adjudication of Cardiac and Cerebrovascular Events	Patients reported with cardiac and cerebrovascular events qualified for adjudication by the Clinical Event Committee (CEC)	78 weeks	Yes
Primary	Number of Patients With Abnormalities in Vital Signs	Vital sign abnormalities (any abnormalities found during PE or ECG are reported with adverse events)	78 weeks	Yes
Primary	Number of Patients With Abnormalities in Haematology: Eosinophils	For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 10%.	78 weeks	Yes
Primary	Number of Patients With Abnormalities in Haematology: Haemoglobin	For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 11.5 g/dL for male and as a value less than or equal to 9.5 g/dL for female patients.	78 weeks	Yes
Primary	Number of Patients With Abnormalities in Haematology: Haematocrit	For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 32%.	78 weeks	Yes
Primary	Number of Patients With Abnormalities in Haematology: Red Blood Cell Count	For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 * 10^12/L.	78 weeks	Yes
Primary	Number of Patients With Abnormalities in Haematology: White Blood Cell Count	For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 * 10^9/L (decrease) or a value greater than 20.1 * 10^9/L (increase).	78 weeks	Yes
Primary	Number of Patients With Abnormalities in Haematology: Platelets	For this laboratory parameter, a possibly clinically significant abnormality is defined as value less than or equal to 75 * 10^9/L (decrease) or a value greater than or equal to 700 * 10^9/L (increase).	78 weeks	Yes
Primary	Number of Patients With Abnormalities in Clinical Chemistry: Potassium	For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 mmol/L (decrease) or a value greater than 5.8 mmol/L (increase).	78 weeks	Yes
Primary	Number of Patients With Abnormalities in Clinical Chemistry: Uric Acid	For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 11 mg/dL for male and as a value greater than 10 mg/dL for female patients.	78 weeks	Yes
Primary	Number of Patients With Abnormalities in Clinical Chemistry: Triglycerides	For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.	78 weeks	Yes
Primary	Number of Patients With Abnormalities in Clinical Chemistry: Amylase	For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 1.5 times the upper limit of normal (ULN).	78 weeks	Yes
Primary	Number of Patients With Abnormalities in Clinical Chemistry: ?-Glutamyl-transferase (GGT)	For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.	78 weeks	Yes
Primary	Number of Patients With Abnormalities in Clinical Chemistry: Creatinine	For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 1.5 mg/dL.	78 weeks	Yes
Primary	Number of Patients With Abnormalities in Clinical Chemistry: Creatinine Kinase	For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.	78 weeks	Yes
Primary	Number of Patients With Abnormalities in Clinical Chemistry: Phosphate	For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 0.7 mmol/L (decrease) or a value greater than 1.7 mmol/L (increase).	78 weeks	Yes
Primary	Number of Patients With Abnormalities in Clinical Chemistry: Calcium	For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 1.8 mmol/L (decrease) or a value greater than 3 mmol/L (increase).	78 weeks	Yes
Primary	Number of Patients With Abnormalities in Clinical Chemistry: Sodium	For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 130 mmol/L (decrease) or a value greater than 160 mmol/L (increase).	78 weeks	Yes
Primary	Number of Patients With Abnormalities in Clinical Chemistry: Alanine Transaminase (ALT)	For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.	78 weeks	Yes
Primary	Number of Patients With Abnormalities in Clinical Chemistry: Aspartate Transaminase (AST)	For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.	78 weeks	Yes
Primary	Number of Patients With Abnormalities in Clinical Chemistry: Glucose	For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 54 mg/dL.	78 weeks	Yes
Primary	Number of Patients With Abnormalities in Clinical Chemistry: Bilirubin	For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 mg/dL.	78 weeks	Yes
Primary	Number of Patients With Abnormalities in Clinical Chemistry: Alkaline Phosphatase (AP)	For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 times the ULN.	78 weeks	Yes
Primary	Number of Patients With Abnormalities in Clinical Chemistry: Albumin	For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 2.5 g/dL.	78 weeks	Yes
Primary	Number of Patients With Abnormalities in Clinical Chemistry: Lactate Dehydrogenase (LDH)	For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.	78 weeks	Yes
Primary	Number of Patients With Abnormalities in Clinical Chemistry: Cholesterol	For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.	78 weeks	Yes
Secondary	Change in HbA1c From Baseline to Week 6		Baseline and week 6	No
Secondary	Change in HbA1c From Baseline to Week 18		Baseline and week 18	No
Secondary	Change in HbA1c From Baseline to Week 30		Baseline and week 30	No
Secondary	Change in HbA1c From Baseline to Week 42		Baseline and week 42	No
Secondary	Change in HbA1c From Baseline to Week 54		Baseline and week 54	No
Secondary	Change in HbA1c From Baseline to Week 66		Baseline and week 66	No
Secondary	Change in HbA1c From Baseline to Week 78		Baseline and week 78	No
Secondary	Number of Patients With HbA1c<7.0% Over Time		78 weeks	No
Secondary	Number of Patients With HbA1c<6.5% Over Time		78 weeks	No
Secondary	Number of Patients With Lowered HbA1c by at Least 0.5% Over Time		78 weeks	No
Secondary	Change in FPG From Baseline to Week 6		Baseline and week 6	No
Secondary	Change in FPG From Baseline to Week 18		Baseline and week 18	No
Secondary	Change in FPG From Baseline to Week 30		Baseline and week 30	No
Secondary	Change in FPG From Baseline to Week 42		Baseline and week 42	No
Secondary	Change in FPG From Baseline to Week 54		Baseline and week 54	No
Secondary	Change in FPG From Baseline to Week 66		Baseline and week 66	No
Secondary	Change in FPG From Baseline to Week 78		Baseline and week 78	No

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