A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy

PHASE2CompletedINTERVENTIONAL
Enrollment

983

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

December 31, 2013

Study Completion Date

December 31, 2013

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

Placebo

Patients receive placebo matching empagliflozin (low dose qd)

DRUG

Placebo

Patients receive placebo matching empagliflozin (low dose bid)

DRUG

Placebo

Patients receive placebo matching Empagliflozin (high dose qd)

DRUG

Placebo

Patients receive placebo matching Empagliflozin (high dose qd)

DRUG

Placebo

Patients receive placebo matching Empagliflozin (high dose qd)

DRUG

empagliflozin (low dose qd)

Patients receive Empagliflozin low dose once daily

DRUG

Placebo

Patients receive placebo matching empagliflozin (low dose qd)

DRUG

Placebo

Patients receive placebo matching empagliflozin (low dose bid)

DRUG

Placebo

Patients receive placebo matching Empagliflozin (high dose bid)

DRUG

Placebo

Patients receive placebo matching Empagliflozin (high dose bid)

DRUG

Placebo

Patients receive placebo matching empagliflozin (low dose qd)

DRUG

Placebo

Patients receive placebo matching empagliflozin (low dose bid)

DRUG

Placebo

Patients receive placebo matching Empagliflozin (high dose bid)

DRUG

Placebo

Patients receive placebo matching empagliflozin (low dose qd)

DRUG

Placebo

Patients receive placebo matching empagliflozin (low dose bid)

DRUG

Placebo

Patients receive placebo matching Empagliflozin (high dose bid)

DRUG

Empagliflozin (high dose qd)

Patients receive Empagliflozin high dose once daily

DRUG

empagliflozin (high dose bid)

Patients receive Empagliflozin high dose split twice daily

DRUG

Placebo

Patients receive placebo matching Empagliflozin (high dose qd)

DRUG

empagliflozin (low dose bid)

Patients receive Empagliflozin low dose split twice daily

Trial Locations (139)

Unknown

1276.10.11036 Boehringer Ingelheim Investigational Site, Florence

1276.10.11049 Boehringer Ingelheim Investigational Site, Jonesboro

1276.10.11040 Boehringer Ingelheim Investigational Site, Lomita

1276.10.11033 Boehringer Ingelheim Investigational Site, Los Angeles

1276.10.11002 Boehringer Ingelheim Investigational Site, Rancho Cucamonga

1276.10.11050 Boehringer Ingelheim Investigational Site, Sacramento

1276.10.11015 Boehringer Ingelheim Investigational Site, West Hills

1276.10.11012 Boehringer Ingelheim Investigational Site, Norwalk

1276.10.11047 Boehringer Ingelheim Investigational Site, Waterbury

1276.10.11010 Boehringer Ingelheim Investigational Site, Bradenton

1276.10.11005 Boehringer Ingelheim Investigational Site, Davie

1276.10.11004 Boehringer Ingelheim Investigational Site, Jacksonville

1276.10.11051 Boehringer Ingelheim Investigational Site, Miami

1276.10.11009 Boehringer Ingelheim Investigational Site, Oakland Park

1276.10.11044 Boehringer Ingelheim Investigational Site, Palm Harbor

1276.10.11030 Boehringer Ingelheim Investigational Site, Dunwoody

1276.10.11027 Boehringer Ingelheim Investigational Site, Chicago

1276.10.11020 Boehringer Ingelheim Investigational Site, Elwood

1276.10.11001 Boehringer Ingelheim Investigational Site, Bangor

1276.10.11048 Boehringer Ingelheim Investigational Site, Sterling Heights

1276.10.11058 Boehringer Ingelheim Investigational Site, Jackson

1276.10.11055 Boehringer Ingelheim Investigational Site, Edison

1276.10.11011 Boehringer Ingelheim Investigational Site, Brooklyn

1276.10.11035 Boehringer Ingelheim Investigational Site, North Myrtle Beach

1276.10.11041 Boehringer Ingelheim Investigational Site, Winston-Salem

1276.10.11018 Boehringer Ingelheim Investigational Site, Cincinnati

1276.10.11043 Boehringer Ingelheim Investigational Site, Dayton

1276.10.11017 Boehringer Ingelheim Investigational Site, Kettering

1276.10.11022 Boehringer Ingelheim Investigational Site, Fleetwood

1276.10.11003 Boehringer Ingelheim Investigational Site, Johnson City

1276.10.11042 Boehringer Ingelheim Investigational Site, Corpus Christi

1276.10.11013 Boehringer Ingelheim Investigational Site, Dallas

1276.10.11026 Boehringer Ingelheim Investigational Site, Houston

1276.10.11031 Boehringer Ingelheim Investigational Site, Houston

1276.10.11034 Boehringer Ingelheim Investigational Site, Houston

1276.10.11028 Boehringer Ingelheim Investigational Site, Pearland

1276.10.11029 Boehringer Ingelheim Investigational Site, San Antonio

1276.10.11016 Boehringer Ingelheim Investigational Site, Port Orchard

1276.10.11024 Boehringer Ingelheim Investigational Site, Spokane

1276.10.61002 Boehringer Ingelheim Investigational Site, Wollongong

1276.10.61001 Boehringer Ingelheim Investigational Site, Box Hill

1276.10.20008 Boehringer Ingelheim Investigational Site, Calgary

1276.10.20005 Boehringer Ingelheim Investigational Site, Surrey

1276.10.20010 Boehringer Ingelheim Investigational Site, Winnipeg

1276.10.20002 Boehringer Ingelheim Investigational Site, Bathurst

1276.10.20001 Boehringer Ingelheim Investigational Site, Brampton

1276.10.20007 Boehringer Ingelheim Investigational Site, Corunna

1276.10.20006 Boehringer Ingelheim Investigational Site, Sarnia

1276.10.20004 Boehringer Ingelheim Investigational Site, Drummondville

1276.10.20003 Boehringer Ingelheim Investigational Site, Point Claire

1276.10.20009 Boehringer Ingelheim Investigational Site, Victoriaville

1276.10.37203 Boehringer Ingelheim Investigational Site, Pärnu

1276.10.37201 Boehringer Ingelheim Investigational Site, Tallinn

1276.10.37202 Boehringer Ingelheim Investigational Site, Tallinn

1276.10.37204 Boehringer Ingelheim Investigational Site, Viljandi County

1276.10.33002 Boehringer Ingelheim Investigational Site, Aire-sur-l'Adour

1276.10.33003 Boehringer Ingelheim Investigational Site, Bischheim

1276.10.33009 Boehringer Ingelheim Investigational Site, Bourg-des-Comptes

1276.10.33014 Boehringer Ingelheim Investigational Site, Bourges

1276.10.33007 Boehringer Ingelheim Investigational Site, Broglie

1276.10.33001 Boehringer Ingelheim Investigational Site, Mont-de-Marsan

1276.10.33008 Boehringer Ingelheim Investigational Site, Paris

1276.10.33006 Boehringer Ingelheim Investigational Site, Saint Vinecnt de Tyrosse

1276.10.33011 Boehringer Ingelheim Investigational Site, Segré

1276.10.33004 Boehringer Ingelheim Investigational Site, Strasbourg

1276.10.99501 Boehringer Ingelheim Investigational Site, Tbilisi

1276.10.99502 Boehringer Ingelheim Investigational Site, Tbilisi

1276.10.99503 Boehringer Ingelheim Investigational Site, Tbilisi

1276.10.99504 Boehringer Ingelheim Investigational Site, Tbilisi

1276.10.99505 Boehringer Ingelheim Investigational Site, Tbilisi

1276.10.99506 Boehringer Ingelheim Investigational Site, Tbilisi

1276.10.49001 Boehringer Ingelheim Investigational Site, Aschaffenburg

1276.10.49006 Boehringer Ingelheim Investigational Site, Berlin

1276.10.49007 Boehringer Ingelheim Investigational Site, Berlin

1276.10.49005 Boehringer Ingelheim Investigational Site, Essen

1276.10.49004 Boehringer Ingelheim Investigational Site, Frankfurt

1276.10.49002 Boehringer Ingelheim Investigational Site, Nuremberg

1276.10.49003 Boehringer Ingelheim Investigational Site, Rehlingen-Siersburg

1276.10.50201 Boehringer Ingelheim Investigational Site, Guatemala Ciudad

1276.10.50203 Boehringer Ingelheim Investigational Site, Guatemala Ciudad

1276.10.50204 Boehringer Ingelheim Investigational Site, Guatemala Ciudad

1276.10.50205 Boehringer Ingelheim Investigational Site, Guatemala Ciudad

1276.10.50202 Boehringer Ingelheim Investigational Site, Quetzaltenango Ciudad

1276.10.39004 Boehringer Ingelheim Investigational Site, Arenzano (GE)

1276.10.39003 Boehringer Ingelheim Investigational Site, Bologna

1276.10.39007 Boehringer Ingelheim Investigational Site, Catanzaro

1276.10.39009 Boehringer Ingelheim Investigational Site, Catanzaro

1276.10.39002 Boehringer Ingelheim Investigational Site, Napoli

1276.10.39006 Boehringer Ingelheim Investigational Site, Palermo

1276.10.39001 Boehringer Ingelheim Investigational Site, Roma

1276.10.39008 Boehringer Ingelheim Investigational Site, Roma

1276.10.39005 Boehringer Ingelheim Investigational Site, Torino

1276.10.37102 Boehringer Ingelheim Investigational Site, Daugavpils

1276.10.37104 Boehringer Ingelheim Investigational Site, Ogre

1276.10.37101 Boehringer Ingelheim Investigational Site, Riga

1276.10.37103 Boehringer Ingelheim Investigational Site, Tukums

1276.10.37003 Boehringer Ingelheim Investigational Site, Kaunas

1276.10.37004 Boehringer Ingelheim Investigational Site, Kaunas

1276.10.37002 Boehringer Ingelheim Investigational Site, Klaipėda

1276.10.37001 Boehringer Ingelheim Investigational Site, Vilnius

1276.10.52003 Boehringer Ingelheim Investigational Site, Durango

1276.10.52001 Boehringer Ingelheim Investigational Site, Mexico City

1276.10.52002 Boehringer Ingelheim Investigational Site, Mexico City

1276.10.52005 Boehringer Ingelheim Investigational Site, Pachuca

1276.10.52004 Boehringer Ingelheim Investigational Site, Tijuana

1276.10.64001 Boehringer Ingelheim Investigational Site, Christchurch

1276.10.64002 Boehringer Ingelheim Investigational Site, Greenlane East Auckland NZ

1276.10.48001 Boehringer Ingelheim Investigational Site, Bialystok

1276.10.48002 Boehringer Ingelheim Investigational Site, Bialystok

1276.10.48008 Boehringer Ingelheim Investigational Site, Giżycko

1276.10.48005 Boehringer Ingelheim Investigational Site, Katowice

1276.10.48006 Boehringer Ingelheim Investigational Site, Katowice

1276.10.48004 Boehringer Ingelheim Investigational Site, Krakow

1276.10.48003 Boehringer Ingelheim Investigational Site, Warsaw

1276.10.70001 Boehringer Ingelheim Investigational Site, Moscow

1276.10.70002 Boehringer Ingelheim Investigational Site, Moscow

1276.10.70003 Boehringer Ingelheim Investigational Site, Moscow

1276.10.70004 Boehringer Ingelheim Investigational Site, Moscow

1276.10.70005 Boehringer Ingelheim Investigational Site, Moscow

1276.10.70007 Boehringer Ingelheim Investigational Site, Moscow

1276.10.70008 Boehringer Ingelheim Investigational Site, Saint Petersburg

1276.10.70009 Boehringer Ingelheim Investigational Site, Saint Petersburg

1276.10.27004 Boehringer Ingelheim Investigational Site, Paarl

1276.10.27003 Boehringer Ingelheim Investigational Site, Parow

1276.10.27006 Boehringer Ingelheim Investigational Site, Plumstead, Cape Town

1276.10.27001 Boehringer Ingelheim Investigational Site, Pretoria

1276.10.27005 Boehringer Ingelheim Investigational Site, Pretoria

1276.10.27002 Boehringer Ingelheim Investigational Site, Somerset West

1276.10.34005 Boehringer Ingelheim Investigational Site, Barcelona

1276.10.34001 Boehringer Ingelheim Investigational Site, L'Hospitalet de Llobregat

1276.10.34003 Boehringer Ingelheim Investigational Site, L'Hospitalet de Llobregat

1276.10.34002 Boehringer Ingelheim Investigational Site, les Borges del Camp

1276.10.34004 Boehringer Ingelheim Investigational Site, Sant Adria Del Besos

1276.10.34006 Boehringer Ingelheim Investigational Site, Vic

1276.10.38002 Boehringer Ingelheim Investigational Site, Kharkiv

1276.10.38007 Boehringer Ingelheim Investigational Site, Kharkiv

1276.10.38001 Boehringer Ingelheim Investigational Site, Kiev

1276.10.38004 Boehringer Ingelheim Investigational Site, Kiev

1276.10.38005 Boehringer Ingelheim Investigational Site, Kyiv

Sponsors
All Listed Sponsors
collaborator

Eli Lilly and Company

INDUSTRY

lead

Boehringer Ingelheim

INDUSTRY