Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes

PHASE4CompletedINTERVENTIONAL
Enrollment

480

Participants

Timeline

Start Date

May 31, 2007

Primary Completion Date

April 30, 2008

Study Completion Date

April 30, 2008

Conditions
DiabetesDiabetes Mellitus, Type 2
Interventions
DRUG

biphasic insulin aspart

Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.

DRUG

insulin glargine

Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.

DRUG

metformin

Tablets, 2550 mcg. Administered once daily.

DRUG

glimepiride

Tablets 2 mg. 4, 6 or 8 mg administered once daily.

Trial Locations (69)

1014

Novo Nordisk Investigational Site, Manila

1100

Novo Nordisk Investigational Site, Vienna

Novo Nordisk Investigational Site, Quezon City

1102

Novo Nordisk Investigational Site, Quezon City

3160

Novo Nordisk Investigational Site, Traisen

4001

Novo Nordisk Investigational Site, Durban

4091

Novo Nordisk Investigational Site, Durban

4600

Novo Nordisk Investigational Site, Wels

6807

Novo Nordisk Investigational Site, Feldkirch

9301

Novo Nordisk Investigational Site, Bloemfontein

10990

Novo Nordisk Investigational Site, Pulau Pinang

11108

Novo Nordisk Investigational Site, Narbonne

16150

Novo Nordisk Investigational Site, Kota Bharu, Kelantan

17019

Novo Nordisk Investigational Site, La Rochelle

18000

Novo Nordisk Investigational Site, Nis

21000

Novo Nordisk Investigational Site, Novi Sad

28040

Novo Nordisk Investigational Site, Madrid

28041

Novo Nordisk Investigational Site, Madrid

29009

Novo Nordisk Investigational Site, Málaga

34000

Novo Nordisk Investigational Site, Kragujevac

42060

Novo Nordisk Investigational Site, Pachuca

44600

Novo Nordisk Investigational Site, Guadalajara

44620

Novo Nordisk Investigational Site, Guadalajara

46600

Novo Nordisk Investigational Site, Alzira

56000

Novo Nordisk Investigational Site, Cheras

58033

Novo Nordisk Investigational Site, Nevers

87042

Novo Nordisk Investigational Site, Limoges

97159

Novo Nordisk Investigational Site, Pointe à Pitre

130083

Novo Nordisk Investigational Site, Târgovişte

132001

Novo Nordisk Investigational Site, Karnāl

380006

Novo Nordisk Investigational Site, Ahmedabad

440055

Novo Nordisk Investigational Site, Satu Mare

530001

Novo Nordisk Investigational Site, Visakhapatnam

560043

Novo Nordisk Investigational Site, Bangalore

710224

Novo Nordisk Investigational Site, Botoșani

800371

Novo Nordisk Investigational Site, Galati

C1181ACH

Novo Nordisk Investigational Site, Buenos Aires

C1405CWB

Novo Nordisk Investigational Site, Ciudad Autonoma de Bs As

C1406FWY

Novo Nordisk Investigational Site, Ciudad Autónoma de BsAs

B7602CBM

Novo Nordisk Investigational Site, Mar del Plata

A - 6900

Novo Nordisk Investigational Site, Bregenz

656 91

Novo Nordisk Investigational Site, Brno

500 05

Novo Nordisk Investigational Site, Hradec Králové

06250

Novo Nordisk Investigational Site, Mougins

1311RL

Novo Nordisk Investigational Site, Almere Stad

9711 SG

Novo Nordisk Investigational Site, Groningen

2352 RA

Novo Nordisk Investigational Site, Leiderdorp

3021 HC

Novo Nordisk Investigational Site, Rotterdam

2724 EK

Novo Nordisk Investigational Site, Zoetermeer

15-276

Novo Nordisk Investigational Site, Bialystok

85-094

Novo Nordisk Investigational Site, Bydgoszcz

80-858

Novo Nordisk Investigational Site, Gdansk

81-366

Novo Nordisk Investigational Site, Gdynia

31-501

Novo Nordisk Investigational Site, Krakow

90-153

Novo Nordisk Investigational Site, Lodz

59-301

Novo Nordisk Investigational Site, Lubin

20-081

Novo Nordisk Investigational Site, Lublin

10-561

Novo Nordisk Investigational Site, Olsztyn

60-821

Novo Nordisk Investigational Site, Poznan

35-301

Novo Nordisk Investigational Site, Rzeszów

71-455

Novo Nordisk Investigational Site, Szczecin

02-507

Novo Nordisk Investigational Site, Warsaw

41-800

Novo Nordisk Investigational Site, Zabrze

020475

Novo Nordisk Investigational Site, Bucharest

0250

Novo Nordisk Investigational Site, Brits

413 45

Novo Nordisk Investigational Site, Gothenburg

221 85

Novo Nordisk Investigational Site, Lund

205 02

Novo Nordisk Investigational Site, Malmo

182 88

Novo Nordisk Investigational Site, Stockholm

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY

NCT00469092 - Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes | Biotech Hunter | Biotech Hunter