Efficacy and Safety of Dapagliflozin, Added to Therapy of Patients With Type 2 Diabetes With Inadequate Glycemic Control on Insulin

PHASE3CompletedINTERVENTIONAL
Enrollment

1,240

Participants

Timeline

Start Date

April 30, 2008

Primary Completion Date

May 31, 2009

Study Completion Date

January 31, 2011

Conditions
Type 2 Diabetes
Interventions
DRUG

Dapagliflozin

tablet oral 2.5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)

DRUG

Dapagliflozin

Tablet oral 5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)

DRUG

Dapagliflozin

Tablet oral 10 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)

DRUG

Placebo

Placebo

DRUG

Dapagliflozin

tablet oral 2.5 total daily dose once daily 56 weeks (= 56 week study extension period II)

DRUG

Dapagliflozin

tablet oral 10 mg total daily dose once daily 56 weeks (= 56 week study extension period II)patients that have been treated with 5 mg during the 24 week randomised treatment period and extension I period will during extension II period switched to 10 mg

Trial Locations (92)

Unknown

Research Site, Fresno

Research Site, Greenbrae

Research Site, Roswell

Research Site, Chicago

Research Site, Springfield

Research Site, Indianapolis

Research Site, Omaha

Research Site, Philadelphia

Research Site, Corpus Christi

Research Site, Dallas

Research Site, Norfolk

Research Site, Richmond

Research Site, Tacoma

Research Site, Salzburg

Research Site, Vienna

Research Site, Pleven

Research Site, Rousse

Research Site, Sofia

Research Site, Varna

Research Site, Calgary

Research Site, Kelowna

Research Site, Langley

Research Site, Winnipeg

Research Site, Moncton

Research Site, Mount Pearl

Research Site, St. John's

Research Site, Halifax

Research Site, Etobicoke

Research Site, Kingston

Research Site, London

Research Site, Oakville

Research Site, Scarborough Village

Research Site, Thornhill

Research Site, Chicoutimi

Research Site, Longueuil

Research Site, Mirabel

Research Site, Sherbrooke

Research Site, Lahti

Research Site, Helsinki

Research Site, Joensuu

Research Site, Jyväskylä

Research Site, Kuopio

Research Site, Oulu

Research Site, Seinäjoki

Research Site, Turku

Research Site, Bad Oeynhausen

Research Site, Dortmund

Research Site, Dresden

Research Site, Essen

Research Site, Frankfurt

Research Site, Magdeburg

Research Site, Münster

Research Site, Riesa

Research Site, Wolmirstedt

Research Site, Csongrád

Research Site, Esztergom

Research Site, Győr

Research Site, Kaposvár

Research Site, Kecskemét

Research Site, Komárom

Research Site, Miskolc

Research Site, Székesfehérvár

Research Site, Veszprém

Research Site, Amersfoort

Research Site, Den Helder

Research Site, Leiden

Research Site, Rotterdam

Research Site, Brasov

Research Site, Tg Mures

Research Site, Bucharest

Research Site, Moscow

Research Site, Nizhny Novgorod

Research Site, Saint Petersburg

Research Site, Bratislava

Research Site, Dolný Kubín

Research Site, Košice

Research Site, Levice

Research Site, Lučenec

Research Site, Považská Bystrica

Research Site, Prešov

Research Site, Seville

Research Site, Sabadell (barcelona)

Research Site, Madrid

Research Site, Alicante

Research Site, Reading

Research Site, Aylesbury

Research Site, Ashford

Research Site, Birmingham

Research Site, Cardiff

Research Site, Liverpool

Research Site, Reading

Research Site, Swansea

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

AstraZeneca

INDUSTRY