A Study to Compare Insulin Intensification of Biphasic Insulin Aspart 30 and Insulin Analogues (Insulin Glargine and Insulin Aspart) in Insulin naïve Type 2 Diabetic Patients

PHASE4CompletedINTERVENTIONAL
Enrollment

335

Participants

Timeline

Start Date

August 31, 2015

Primary Completion Date

September 20, 2016

Study Completion Date

September 20, 2016

Conditions
DiabetesDiabetes Mellitus, Type 2
Interventions
DRUG

biphasic insulin aspart 30

Injected s.c./subcutaneously once daily with the largest meal Subjects should continue their pre-trial metformin and sulfonylurea dosages all throughout the trial while other oral antidiabetic drugs will be discontinued.

DRUG

insulin glargine

Injected s.c./subcutaneously once daily at the same time every day, with the possibility of treatment intensification with insulin aspart (Basal-bolus arm) Subjects should continue their pre-trial metformin and sulfonylurea dosages all throughout the trial while other oral antidiabetic drugs will be discontinued.

DRUG

insulin aspart

Injected s.c./subcutaneously once daily.

Trial Locations (41)

24

Novo Nordisk Investigational Site, Umm Al Quwain City

1032

Novo Nordisk Investigational Site, Budapest

1042

Novo Nordisk Investigational Site, Budapest

1202

Novo Nordisk Investigational Site, Sofia

1431

Novo Nordisk Investigational Site, Sofia

1606

Novo Nordisk Investigational Site, Sofia

2292

Novo Nordisk Investigational Site, Broadmeadow

2450

Novo Nordisk Investigational Site, Coffs Harbour

2850

Novo Nordisk Investigational Site, Petrich

3004

Novo Nordisk Investigational Site, Melbourne

3065

Novo Nordisk Investigational Site, Fitzroy

4305

Novo Nordisk Investigational Site, Ipswich

4400

Novo Nordisk Investigational Site, Nyíregyhaza

4727

Novo Nordisk Investigational Site, Ras al-Khaimah

8800

Novo Nordisk Investigational Site, Sliven

10330

Novo Nordisk Investigational Site, Bangkok

10400

Novo Nordisk Investigational Site, Bangkok

10700

Novo Nordisk Investigational Site, Bangkoknoi, Bangkok

11000

Novo Nordisk Investigational Site, Belgrade

11080

Novo Nordisk Investigational Site, Belgrade

18000

Novo Nordisk Investigational Site, Niš

21499

Novo Nordisk Investigational Site, Ajman

22241

Novo Nordisk Investigational Site, Dubai

34303

Novo Nordisk Investigational Site, Istanbul

34752

Novo Nordisk Investigational Site, Istanbul

40002

Novo Nordisk Investigational Site, Khon Kaen

44280

Novo Nordisk Investigational Site, Malatya

53020

Novo Nordisk Investigational Site, Rize

110001

Novo Nordisk Investigational Site, New Delhi

135710

Novo Nordisk Investigational Site, Seoul

400008

Novo Nordisk Investigational Site, Mumbai

400058

Novo Nordisk Investigational Site, Mumbai

500003

Novo Nordisk Investigational Site, Hyderabad

560060

Novo Nordisk Investigational Site, Bangalore

632004

Novo Nordisk Investigational Site, Vellore

700032

Novo Nordisk Investigational Site, Kolkata

625 020

Novo Nordisk Investigational Site, Madurai

02447

Novo Nordisk Investigational Site, Seoul

03722

Novo Nordisk Investigational Site, Seoul

138-736

Novo Nordisk Investigational Site, Seoul

07058

Novo Nordisk Investigational Site, Antalya

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY