NCT01183013View on ClinicalTrials.gov

30 Week Parallel Group Comparison Study of Linagliptin + Pioglitazone (5+15, 5+30 and 5+45 mg) qd Versus Respective Monotherapies, Followed by a Comparison of 5mg+30mg and 5mg+45mg Versus Respective Monotherapies in Type 2 Diabetes for up to 54 Weeks

PHASE3CompletedINTERVENTIONAL
Enrollment

936

Participants

Timeline

Start Date

August 31, 2010

Primary Completion Date

February 28, 2013

Study Completion Date

February 28, 2013

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

Pioglitazone 15 mg

Pioglitazone Capsules 15 mg once daily for 30 weeks followed by Pioglitazone Capsules 30 mg once daily for up to 54 weeks

DRUG

Pioglitazone 45 mg

Pioglitazone Capsules 30 mg once daily for 6 weeks followed by Pioglitazone Capsules 45 mg once daily for up to 78 weeks

DRUG

Pioglitazone 30 mg

Pioglitazone Capsules 30 mg once daily for up to 84 weeks

DRUG

Linagliptin 5mg / Pioglitazone 45 mg FDC

Linagliptin 5mg low dose / Pioglitazone 30 mg Tablets once daily for 6 weeks followed by Linagliptin 5mg low dose / Pioglitazone 45 mg FDC Tablets once daily for up to 78 weeks

DRUG

Linagliptin 5mg / Pioglitazone 30 mg FDC

Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 84 weeks

DRUG

Linagliptin 5mg

Linagliptin 5mg Tablets low dose once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks

DRUG

Linagliptin 5mg / Pioglitazone 15 mg FDC

Linagliptin 5mg low dose / Pioglitazone 15 mg FDC Tablets once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks

Trial Locations (132)

Unknown

1264.3.01026 Boehringer Ingelheim Investigational Site, Birmingham

1264.3.01021 Boehringer Ingelheim Investigational Site, Montgomery

1264.3.01020 Boehringer Ingelheim Investigational Site, Muscle Shoals

1264.3.01062 Boehringer Ingelheim Investigational Site, Chandler

1264.3.01064 Boehringer Ingelheim Investigational Site, Mesa

1264.3.01049 Boehringer Ingelheim Investigational Site, Carmichael

1264.3.01078 Boehringer Ingelheim Investigational Site, Chino

1264.3.01031 Boehringer Ingelheim Investigational Site, Concord

1264.3.01037 Boehringer Ingelheim Investigational Site, Lakewood

1264.3.01065 Boehringer Ingelheim Investigational Site, Los Angeles

1264.3.01006 Boehringer Ingelheim Investigational Site, Norwalk

1264.3.01001 Boehringer Ingelheim Investigational Site, Rancho Cucamonga

1264.3.01059 Boehringer Ingelheim Investigational Site, San Diego

1264.3.01023 Boehringer Ingelheim Investigational Site, Tarzana

1264.3.01016 Boehringer Ingelheim Investigational Site, Tustin

1264.3.01058 Boehringer Ingelheim Investigational Site, Valencia

1264.3.01083 Boehringer Ingelheim Investigational Site, Westlake Village

1264.3.01027 Boehringer Ingelheim Investigational Site, Denver

1264.3.01033 Boehringer Ingelheim Investigational Site, Norwalk

1264.3.01035 Boehringer Ingelheim Investigational Site, Boca Raton

1264.3.01015 Boehringer Ingelheim Investigational Site, Clearwater

1264.3.01082 Boehringer Ingelheim Investigational Site, Hialeah

1264.3.01036 Boehringer Ingelheim Investigational Site, Jacksonville

1264.3.01013 Boehringer Ingelheim Investigational Site, Longwood

1264.3.01038 Boehringer Ingelheim Investigational Site, Miami

1264.3.01042 Boehringer Ingelheim Investigational Site, Miami

1264.3.01079 Boehringer Ingelheim Investigational Site, Miami

1264.3.01019 Boehringer Ingelheim Investigational Site, Port Orange

1264.3.01018 Boehringer Ingelheim Investigational Site, Saint Cloud

1264.3.01009 Boehringer Ingelheim Investigational Site, Tampa

1264.3.01012 Boehringer Ingelheim Investigational Site, Tampa

1264.3.01008 Boehringer Ingelheim Investigational Site, Atlanta

1264.3.01055 Boehringer Ingelheim Investigational Site, Atlanta

1264.3.01061 Boehringer Ingelheim Investigational Site, Atlanta

1264.3.01074 Boehringer Ingelheim Investigational Site, Blue Ridge

1264.3.01084 Boehringer Ingelheim Investigational Site, Cartersville

1264.3.01060 Boehringer Ingelheim Investigational Site, Perry

1264.3.01050 Boehringer Ingelheim Investigational Site, Savannah

1264.3.01077 Boehringer Ingelheim Investigational Site, Chicago

1264.3.01052 Boehringer Ingelheim Investigational Site, Brownsburg

1264.3.01075 Boehringer Ingelheim Investigational Site, Evansville

1264.3.01076 Boehringer Ingelheim Investigational Site, Evansville

1264.3.01073 Boehringer Ingelheim Investigational Site, Franklin

1264.3.01002 Boehringer Ingelheim Investigational Site, Wichita

1264.3.01007 Boehringer Ingelheim Investigational Site, Wichita

1264.3.01010 Boehringer Ingelheim Investigational Site, Lexington

1264.3.01028 Boehringer Ingelheim Investigational Site, New Orleans

1264.3.01029 Boehringer Ingelheim Investigational Site, Sunset

1264.3.01069 Boehringer Ingelheim Investigational Site, Hyattsville

1264.3.01066 Boehringer Ingelheim Investigational Site, Southfield

1264.3.01057 Boehringer Ingelheim Investigational Site, Great Falls

1264.3.01045 Boehringer Ingelheim Investigational Site, Burlington

1264.3.01044 Boehringer Ingelheim Investigational Site, Charlotte

1264.3.01022 Boehringer Ingelheim Investigational Site, Zanesville

1264.3.01032 Boehringer Ingelheim Investigational Site, Oklahoma City

1264.3.01051 Boehringer Ingelheim Investigational Site, Fleetwood

1264.3.01025 Boehringer Ingelheim Investigational Site, Pittsburgh

1264.3.01081 Boehringer Ingelheim Investigational Site, Columbia

1264.3.01003 Boehringer Ingelheim Investigational Site, Greer

1264.3.01011 Boehringer Ingelheim Investigational Site, Kingsport

1264.3.01017 Boehringer Ingelheim Investigational Site, Corpus Christi

1264.3.01067 Boehringer Ingelheim Investigational Site, Dallas

1264.3.01004 Boehringer Ingelheim Investigational Site, Houston

1264.3.01039 Boehringer Ingelheim Investigational Site, Houston

1264.3.01041 Boehringer Ingelheim Investigational Site, Houston

1264.3.01047 Boehringer Ingelheim Investigational Site, Houston

1264.3.01070 Boehringer Ingelheim Investigational Site, Houston

1264.3.01040 Boehringer Ingelheim Investigational Site, Killeen

1264.3.01048 Boehringer Ingelheim Investigational Site, Midland

1264.3.01030 Boehringer Ingelheim Investigational Site, New Braunfels

1264.3.01071 Boehringer Ingelheim Investigational Site, North Richland Hills

1264.3.01085 Boehringer Ingelheim Investigational Site, Plano

1264.3.01046 Boehringer Ingelheim Investigational Site, San Antonio

1264.3.01056 Boehringer Ingelheim Investigational Site, Norfolk

1264.3.37207 Boehringer Ingelheim Investigational Site, Harju

1264.3.37209 Boehringer Ingelheim Investigational Site, Pärnu

1264.3.37201 Boehringer Ingelheim Investigational Site, Tallinn

1264.3.37202 Boehringer Ingelheim Investigational Site, Tallinn

1264.3.37203 Boehringer Ingelheim Investigational Site, Tallinn

1264.3.37204 Boehringer Ingelheim Investigational Site, Tallinn

1264.3.37205 Boehringer Ingelheim Investigational Site, Tallinn

1264.3.37208 Boehringer Ingelheim Investigational Site, Tallinn

1264.3.37206 Boehringer Ingelheim Investigational Site, Tartu

1264.3.37210 Boehringer Ingelheim Investigational Site, Viljandi County

1264.3.49001 Boehringer Ingelheim Investigational Site, Bad Lauterberg / Harz

1264.3.49007 Boehringer Ingelheim Investigational Site, Dietzenbach

1264.3.49002 Boehringer Ingelheim Investigational Site, Dortmund

1264.3.49009 Boehringer Ingelheim Investigational Site, Essen

1264.3.49003 Boehringer Ingelheim Investigational Site, Hamburg

1264.3.49012 Boehringer Ingelheim Investigational Site, Ingelheim

1264.3.49008 Boehringer Ingelheim Investigational Site, Leipzig

1264.3.49005 Boehringer Ingelheim Investigational Site, Mainz

1264.3.49010 Boehringer Ingelheim Investigational Site, Offenbach

1264.3.49004 Boehringer Ingelheim Investigational Site, Stuhr

1264.3.37105 Boehringer Ingelheim Investigational Site, Daugavpils

1264.3.37112 Boehringer Ingelheim Investigational Site, Daugavpils

1264.3.37113 Boehringer Ingelheim Investigational Site, Daugavpils

1264.3.37110 Boehringer Ingelheim Investigational Site, Jelgava

1264.3.37101 Boehringer Ingelheim Investigational Site, Liepāja

1264.3.37106 Boehringer Ingelheim Investigational Site, Ogre

1264.3.37104 Boehringer Ingelheim Investigational Site, Riga

1264.3.37108 Boehringer Ingelheim Investigational Site, Riga

1264.3.37109 Boehringer Ingelheim Investigational Site, Riga

1264.3.37111 Boehringer Ingelheim Investigational Site, Riga

1264.3.37107 Boehringer Ingelheim Investigational Site, Talsi

1264.3.37102 Boehringer Ingelheim Investigational Site, Tukums

1264.3.37103 Boehringer Ingelheim Investigational Site, Valmiera

1264.3.34013 Boehringer Ingelheim Investigational Site, Badía Del Vallès - Barcelona

1264.3.34001 Boehringer Ingelheim Investigational Site, Barcelona

1264.3.34008 Boehringer Ingelheim Investigational Site, Barcelona

1264.3.34005 Boehringer Ingelheim Investigational Site, Borges Del Camp- Tarragona

1264.3.34006 Boehringer Ingelheim Investigational Site, Canet de Mar - Barcelona

1264.3.34010 Boehringer Ingelheim Investigational Site, Centelles - Barcelona

1264.3.34009 Boehringer Ingelheim Investigational Site, L'Hospitalet de Llobregat

1264.3.34004 Boehringer Ingelheim Investigational Site, L'Hospitalet de Llobregat - Barcelona

1264.3.34002 Boehringer Ingelheim Investigational Site, Sant Adrià Del Besós- Barcelona

1264.3.34007 Boehringer Ingelheim Investigational Site, Tarrega - Lleida

1264.3.34012 Boehringer Ingelheim Investigational Site, Valencia

1264.3.34011 Boehringer Ingelheim Investigational Site, Vic - Barcelona

1264.3.44032 Boehringer Ingelheim Investigational Site, Annan

1264.3.44028 Boehringer Ingelheim Investigational Site, Ash Vale, Aldershot

1264.3.44029 Boehringer Ingelheim Investigational Site, Baillieston, Glasgow

1264.3.44008 Boehringer Ingelheim Investigational Site, Balham

1264.3.44021 Boehringer Ingelheim Investigational Site, Bradford-on-Avon

1264.3.44019 Boehringer Ingelheim Investigational Site, Burbage

1264.3.44012 Boehringer Ingelheim Investigational Site, Chesterfield

1264.3.44027 Boehringer Ingelheim Investigational Site, Chestfield, Whitstable

1264.3.44011 Boehringer Ingelheim Investigational Site, Chippenham

1264.3.44033 Boehringer Ingelheim Investigational Site, Johnstone

1264.3.44007 Boehringer Ingelheim Investigational Site, Midsomer Norton

1264.3.44034 Boehringer Ingelheim Investigational Site, Paisley

1264.3.44031 Boehringer Ingelheim Investigational Site, Warminster

Sponsors
All Listed Sponsors
collaborator

Eli Lilly and Company

INDUSTRY

lead

Boehringer Ingelheim

INDUSTRY