A Study of the Safety and Effectiveness of a R256918 in Patients With Type 2 Diabetes

PHASE2CompletedINTERVENTIONAL
Enrollment

352

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

September 30, 2008

Study Completion Date

September 30, 2008

Conditions
Diabetes Mellitus, Type 2Diabetes MellitusEndocrine System DiseasesNutritional and Metabolic Diseases
Interventions
DRUG

JNJ16269110

5 mg twice daily for 12 weeks

DRUG

JNJ16269110

10 mg twice daily for 12 weeks

DRUG

JNJ16269110

15 mg twice daily for 12 weeks

DRUG

Placebo

twice daily for 12 weeks

DRUG

Metformin

Participants will continue taking metformin at the same dose and according to the same dosing regimen as before the study.

OTHER

Dietary Counseling

Participants will receive dietary counseling at Screening, Week 4, 8, 12, and will be instructed to remain on a calorically appropriate diet with a maximum of 30% of calories derived from fat (in accordance with local practice guidelines for the treatment of type 2 diabetes mellitus) during the entire study.

Trial Locations (62)

Unknown

Edegem

Hellerup

Vipperroed

Helsinki

Hyvinkää

Kuopio

Oulu

Buch

Dresden

Düsseldorf

Hamburg

Mainz

München

Ulm

Bangalore

Chennai

Hyderabad

Mumbai

Nagpur

Pune

Breda

Eindhoven

Leiden

Nijmegen

Rotterdam

Velp Gld

Zoetermeer

Oslo

Paradis

Bialystok

Bydgoszcz

Elblag

Kutno

Lodz

Olsztyn

Pruszków

Torun

Warsaw

Wroclaw

Zielona Góra

Moscow

Saint Petersburg

Saratov

Ängelholm

Gothenburg

Härnösand

Linköping

Lund

Örebro

Stockholm

Bangor

Belfast

Birmingham

Cambridge

Cardiff

Clydebank

Dundee

Liverpool

London

Randalstown

Reading

Salford

All Listed Sponsors
lead

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

NCT00672386 - A Study of the Safety and Effectiveness of a R256918 in Patients With Type 2 Diabetes | Biotech Hunter | Biotech Hunter