Insulins Glargine and gluLisine strAtegy Versus Premixed Insulin strAteGy: a cOmparative Study

PHASE4CompletedINTERVENTIONAL
Enrollment

934

Participants

Timeline

Start Date

February 28, 2010

Primary Completion Date

March 31, 2012

Study Completion Date

March 31, 2012

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

INSULIN GLARGINE

Pharmaceutical form: solution for injection Route of administration: sub-cutaneous injection Dose regimen: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 ml)

DRUG

INSULIN GLULISINE

Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 mL)

DRUG

PREMIXED INSULIN

"Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: - 30% soluble insulin aspart and 70 % protamine-crystallised insulin aspart in pre-filled Flexpen for all the countries except Mexico~* 25 % insulin lispro solution and 75% insulin lispro protamine in cartridges for Humapen Luxura for Mexico only"

Trial Locations (96)

170

Investigational Site Number 170005, Manizales

Investigational Site Number 170004, Pereira

407

Investigational Site Number 158001, Taichung

2300

Investigational Site Number 208-002, København S

2400

Investigational Site Number 208-003, København NV

2650

Investigational Site Number 208-001, Hvidovre

8923

Investigational Site Number 724005, Santa Coloma de Gramanet

15123

Investigational Site Number 300011, Maroussi, Athens

16132

Investigational Site Number 380-001, Genova

17110

Investigational Site Number 792-009, Çanakkale

20020

Investigational Site Number 484004, Aguascalientes

20230

Investigational Site Number 484001, Aguascalientes

21830

Investigational Site Number 792-006, Diyarbakır

23137

Investigational Site Number 158003, Xindian District

27004

Investigational Site Number 724007, Lugo

28805

Investigational Site Number 724004, Madrid

31008

Investigational Site Number 724009, Pamplona

34098

Investigational Site Number 792-004, Istanbul

35340

Investigational Site Number 792-001, Izmir

39100

Investigational Site Number 380-011, Merano

41010

Investigational Site Number 724003, Seville

43100

Investigational Site Number 380-004, Parma

44650

Investigational Site Number 484003, Guadalajara

44680

Investigational Site Number 484002, Guadalajara

46010

Investigational Site Number 724006, Valencia

48960

Investigational Site Number 724008, Galdakao

56429

Investigational Site Number 300010, Thessaloniki

57010

Investigational Site Number 300007, Thessaloniki

58140

Investigational Site Number 792-007, Sivas

65080

Investigational Site Number 792-002, Van

68100

Investigational Site Number 300006, Alexandroupoli

71001

Investigational Site Number 300005, Irakleio

71100

Investigational Site Number 380-007, Foggia

72000

Investigational Site Number 484005, Puebla City

80131

Investigational Site Number 380-009, Napoli

Investigational Site Number 380-012, Napoli

95122

Investigational Site Number 380-010, Catania

95124

Investigational Site Number 380-008, Catania

410169

Investigational Site Number 642003, Oradea

500034

Investigational Site Number 356001, Hyderabad

Investigational Site Number 356005, Hyderabad

560043

Investigational Site Number 356008, Bangalore

560052

Investigational Site Number 356003, Bangalore

560092

Investigational Site Number 356007, Bangalore

700111

Investigational Site Number 642001, Iași

751019

Investigational Site Number 356006, Bhubaneshwar

A-8511

Investigational Site Number 040-004, Sankt Stefan

A-1030

Investigational Site Number 040-002, Vienna

Unknown

Investigational Site Number 040-001, Vienna

Investigational Site Number 040-003, Vienna

Investigational Site Number 156004, Beijing

Investigational Site Number 156005, Beijing

Investigational Site Number 156006, Beijing

Investigational Site Number 156011, Chongqing

Investigational Site Number 156009, Dalian

Investigational Site Number 156008, Guangzhou

Investigational Site Number 156012, Haikou

Investigational Site Number 156007, Nanjing

Investigational Site Number 156001, Shanghai

Investigational Site Number 156002, Shanghai

Investigational Site Number 156003, Shanghai

Investigational Site Number 156010, Shenyang

Investigational Site Number 170001, Bogotá

Investigational Site Number 170002, Bogotá

Investigational Site Number 170003, Bucaramanga

Investigational Site Number 300001, Athens

Investigational Site Number 300002, Athens

Investigational Site Number 300003, Athens

Investigational Site Number 300004, Athens

Investigational Site Number 356004, Trivandrum

Investigational Site Number 380-005, Forlì

Investigational Site Number 001, Kuwait City

Investigational Site Number 642002, Iași

Investigational Site Number 410004, Ansan-si, Kyouggi-do

Investigational Site Number 410003, Koyang-si

Investigational Site Number 410001, Seoul

Investigational Site Number 410002, Seoul

Investigational Site Number 158004, Changhua County

Investigational Site Number 158007, Kaohsiung Hsien,

Investigational Site Number 158006, New Taipei City

Investigational Site Number 158009, Taichung

Investigational Site Number 158005, Tainan City

Investigational Site Number 158002, Taipei

Investigational Site Number 792-016, Konya

Investigational Site Number 792-005, Trabzon

Investigational Site Number 784-001, Dubai

66073-000

Investigational Site Number 076002, Belém

80060-900

Investigational Site Number 076005, Curitiba

60430-370

Investigational Site Number 076004, Fortaleza

90035-001

Investigational Site Number 076001, Porto Alegre

04024-002

Investigational Site Number 076003, São Paulo

546 36

Investigational Site Number 300008, Thessaloniki

00034

Investigational Site Number 380-006, Colleferro

05071

Investigational Site Number 724001, Ávila

08022

Investigational Site Number 724002, Barcelona

06100

Investigational Site Number 792-013, Ankara

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY