Efficacy, Safety and Preference Study of a Insulin Pen PDS290 vs. a Novo Nordisk Marketed Insulin Pen in Diabetics

PHASE3CompletedINTERVENTIONAL
Enrollment

242

Participants

Timeline

Start Date

September 30, 2008

Primary Completion Date

June 30, 2009

Study Completion Date

June 30, 2009

Conditions
DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Delivery Systems
Interventions
DEVICE

FlexTouch®

All subjects to receive insulin detemir treatment (and if relevant insulin aspart) with either a insulin pen PDS290 (FlexTouch®) or a Novo Nordisk marketed insulin pen (FlexPen®) for 12 weeks. After 12 weeks, all subjects will continue their insulin treatment with the other injection device.

DEVICE

FlexPen®

All subjects to receive insulin detemir treatment (and if relevant insulin aspart) with either a insulin pen PDS290 (FlexTouch®) or a Novo Nordisk marketed insulin pen (FlexPen®) for 12 weeks. After 12 weeks, all subjects will continue their insulin treatment with the other injection device.

Trial Locations (65)

16602

Novo Nordisk Investigational Site, Altoona

17015

Novo Nordisk Investigational Site, Carlisle

20782

Novo Nordisk Investigational Site, Hyattsville

20852

Novo Nordisk Investigational Site, Rockville

21204

Novo Nordisk Investigational Site, Baltimore

23462

Novo Nordisk Investigational Site, Virginia Beach

28463

Novo Nordisk Investigational Site, Tabor City

28803

Novo Nordisk Investigational Site, Asheville

29566

Novo Nordisk Investigational Site, Little River

30076

Novo Nordisk Investigational Site, Roswell

30318

Novo Nordisk Investigational Site, Atlanta

30606

Novo Nordisk Investigational Site, Athens

31406

Novo Nordisk Investigational Site, Savannah

32308

Novo Nordisk Investigational Site, Tallahassee

32751

Novo Nordisk Investigational Site, Maitland

33021

Novo Nordisk Investigational Site, Hollywood

33143

Novo Nordisk Investigational Site, Miami

33156

Novo Nordisk Investigational Site, Miami

33433

Novo Nordisk Investigational Site, Boca Raton

34471

Novo Nordisk Investigational Site, Ocala

37411

Novo Nordisk Investigational Site, Chattanooga

40503

Novo Nordisk Investigational Site, Lexington

44060

Novo Nordisk Investigational Site, Mentor

45429

Novo Nordisk Investigational Site, Kettering

45439

Novo Nordisk Investigational Site, Dayton

47904

Novo Nordisk Investigational Site, Lafayette

53209

Novo Nordisk Investigational Site, Milwaukee

58104

Novo Nordisk Investigational Site, Fargo

59701

Novo Nordisk Investigational Site, Butte

60607

Novo Nordisk Investigational Site, Chicago

60616

Novo Nordisk Investigational Site, Chicago

63141

Novo Nordisk Investigational Site, St Louis

65109

Novo Nordisk Investigational Site, Jefferson City

67226

Novo Nordisk Investigational Site, Wichita

68114

Novo Nordisk Investigational Site, Omaha

70002

Novo Nordisk Investigational Site, Metairie

75231

Novo Nordisk Investigational Site, Dallas

76014

Novo Nordisk Investigational Site, Arlington

76054

Novo Nordisk Investigational Site, Hurst

78229

Novo Nordisk Investigational Site, San Antonio

80045

Novo Nordisk Investigational Site, Aurora

80401

Novo Nordisk Investigational Site, Golden

80909

Novo Nordisk Investigational Site, Colorado Springs

84403

Novo Nordisk Investigational Site, Ogden

89030

Novo Nordisk Investigational Site, Las Vegas

89101

Novo Nordisk Investigational Site, Las Vegas

90404

Novo Nordisk Investigational Site, Santa Monica

91436

Novo Nordisk Investigational Site, Encino

92025

Novo Nordisk Investigational Site, Escondido

92064

Novo Nordisk Investigational Site, Poway

92691

Novo Nordisk Investigational Site, Mission Viejo

92780

Novo Nordisk Investigational Site, Tustin

92869

Novo Nordisk Investigational Site, Orange

93720

Novo Nordisk Investigational Site, Fresno

93901

Novo Nordisk Investigational Site, Salinas

94010

Novo Nordisk Investigational Site, Burlingame

94520

Novo Nordisk Investigational Site, Concord

94598

Novo Nordisk Investigational Site, Walnut Creek

96814

Novo Nordisk Investigational Site, Honolulu

98057

Novo Nordisk Investigational Site, Renton

42101-1759

Novo Nordisk Investigational Site, Bowling Green

08009

Novo Nordisk Investigational Site, Berlin

08648

Novo Nordisk Investigational Site, Lawrenceville

45631-1560

Novo Nordisk Investigational Site, Gallipolis

97504-8491

Novo Nordisk Investigational Site, Medford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY