NCT00975286 - 24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine | Biotech Hunter

Enrollment

446

Participants

Timeline

Start Date

October 31, 2009

Primary Completion Date

August 31, 2011

Study Completion Date

August 31, 2011

Conditions

Type 2 Diabetes Mellitus

Interventions

DRUG

Lixisenatide (AVE0010)

Self administered by subcutaneous injections once daily within the hour preceding breakfast.

DRUG

Placebo

Self administered by subcutaneous injections once daily within the hour preceding breakfast.

DRUG

Insulin glargine

Dose to be adjusted to maintain a fasting SMPG between 100 and 80 mg/dL (5.6 and 4.4 mmol/L), inclusive.

DEVICE

Pen auto-injector

Lantus® SoloStar® OptiClik®

DRUG

Metformin

Metformin to be continued at stable dose (at least 1.5 gram per day) up to Week 24.

DRUG

Thiazolidinedione (TZD)

TZD (either rosiglitazone or pioglitazone) if given, to be continued at stable dose up to Week 24.

Trial Locations (140)

407

Sanofi-Aventis Investigational Site Number 158201, Taichung R.o.c.

433

Sanofi-Aventis Investigational Site Number 158203, Taichung

500

Sanofi-Aventis Investigational Site Number 158204, Changhua

710

Sanofi-Aventis Investigational Site Number 158202, Tainan Hsien

1012

Sanofi-Aventis Investigational Site Number 032205, Capital Federal

1036

Sanofi-Aventis Investigational Site Number 348202, Budapest

1425

Sanofi-Aventis Investigational Site Number 032201, Capital Federal

2000

Sanofi-Aventis Investigational Site Number 032203, Rosario

Sanofi-Aventis Investigational Site Number 208202, Frederiksberg

2091

Sanofi-Aventis Investigational Site Number 804201, Kiev

2400

Sanofi-Aventis Investigational Site Number 208201, København NV

4031

Sanofi-Aventis Investigational Site Number 348204, Debrecen

4092

Sanofi-Aventis Investigational Site Number 710201, Durban

4200

Sanofi-Aventis Investigational Site Number 208205, Slagelse

5700

Sanofi-Aventis Investigational Site Number 348206, Gyula

6722

Sanofi-Aventis Investigational Site Number 348203, Szeged

7708

Sanofi-Aventis Investigational Site Number 710202, Cape Town

8230

Sanofi-Aventis Investigational Site Number 348205, Balatonfüred

8900

Sanofi-Aventis Investigational Site Number 348201, Zalaegerszeg

13415

Sanofi-Aventis Investigational Site Number 233203, Tallinn

14050

Sanofi-Aventis Investigational Site Number 484206, México

15006

Sanofi-Aventis Investigational Site Number 203204, Prague

16150

Sanofi-Aventis Investigational Site Number 458203, Kelantan

17019

Sanofi-Aventis Investigational Site Number 250206, La Rochelle

19146

Sanofi-Aventis Investigational Site Number 840202, Philadelphia

20132

Sanofi-Aventis Investigational Site Number 380201, Milan

20781

Sanofi-Aventis Investigational Site Number 840230, Hyattsville

20852

Sanofi-Aventis Investigational Site Number 840209, Rockville

21010

Sanofi-Aventis Investigational Site Number 804204, Vinnytsia

23502

Sanofi-Aventis Investigational Site Number 840227, Norfolk

31096

Sanofi-Aventis Investigational Site Number 376202, Haifa

31156

Sanofi-Aventis Investigational Site Number 804205, Kyiv

32835

Sanofi-Aventis Investigational Site Number 840221, Orlando

34270

Sanofi-Aventis Investigational Site Number 484204, Durango

37620

Sanofi-Aventis Investigational Site Number 840229, Bristol

38138

Sanofi-Aventis Investigational Site Number 840205, Germantown

44060

Sanofi-Aventis Investigational Site Number 840225, Mentor

44093

Sanofi-Aventis Investigational Site Number 250201, Nantes

44281

Sanofi-Aventis Investigational Site Number 376204, Kfar Saba

44600

Sanofi-Aventis Investigational Site Number 484203, Guadalajara

48114

Sanofi-Aventis Investigational Site Number 840219, Brighton

50005

Sanofi-Aventis Investigational Site Number 203202, Hradec Králové

50410

Sanofi-Aventis Investigational Site Number 233204, Tartu

52621

Sanofi-Aventis Investigational Site Number 376203, Tel Litwinsky

53160

Sanofi-Aventis Investigational Site Number 484205, Tlalnepantla

55116

Sanofi-Aventis Investigational Site Number 276202, Mainz

56000

Sanofi-Aventis Investigational Site Number 458202, Kuala Lumpur

58022

Sanofi-Aventis Investigational Site Number 804203, Chernivtsi

58100

Sanofi-Aventis Investigational Site Number 376201, Holon

58103

Sanofi-Aventis Investigational Site Number 840208, Fargo

61260

Sanofi-Aventis Investigational Site Number 380202, Perugia

62250

Sanofi-Aventis Investigational Site Number 484201, Cuernavaca

66386

Sanofi-Aventis Investigational Site Number 276204, Saint Ingbert-Oberwürzbach

69310

Sanofi-Aventis Investigational Site Number 250202, Pierre-Bénite

70808

Sanofi-Aventis Investigational Site Number 840211, Baton Rouge

71024

Sanofi-Aventis Investigational Site Number 233202, Viljandimaa

71200

Sanofi-Aventis Investigational Site Number 250203, Le Creusot

71913

Sanofi-Aventis Investigational Site Number 840206, Hot Springs

72205

Sanofi-Aventis Investigational Site Number 840201, Little Rock

72653

Sanofi-Aventis Investigational Site Number 840212, Mountain Home

75093

Sanofi-Aventis Investigational Site Number 840213, Plano

75230

Sanofi-Aventis Investigational Site Number 840210, Dallas

77081

Sanofi-Aventis Investigational Site Number 840217, Houston

Sanofi-Aventis Investigational Site Number 840228, Houston

80018

Sanofi-Aventis Investigational Site Number 233201, Pärnu

80054

Sanofi-Aventis Investigational Site Number 250204, Amiens

85206

Sanofi-Aventis Investigational Site Number 840223, Mesa

94520

Sanofi-Aventis Investigational Site Number 840215, Concord

94904

Sanofi-Aventis Investigational Site Number 840214, Greenbrae

132001

Sanofi-Aventis Investigational Site Number 356203, Karnāl

194358

Sanofi-Aventis Investigational Site Number 643202, Saint Petersburg

300456

Sanofi-Aventis Investigational Site Number 642207, Timișoara

300593

Sanofi-Aventis Investigational Site Number 642201, Timișoara

330084

Sanofi-Aventis Investigational Site Number 642205, Deva

380015

Sanofi-Aventis Investigational Site Number 356210, Ahmedabad

410030

Sanofi-Aventis Investigational Site Number 643203, Saratov

410598

Sanofi-Aventis Investigational Site Number 642202, Oradea

440012

Sanofi-Aventis Investigational Site Number 356209, Nagpur

452010

Sanofi-Aventis Investigational Site Number 356208, Indore

500326

Sanofi-Aventis Investigational Site Number 642204, Brasov

540061

Sanofi-Aventis Investigational Site Number 642206, Târgu Mureş

560043

Sanofi-Aventis Investigational Site Number 356206, Bangalore

560052

Sanofi-Aventis Investigational Site Number 356204, Bangalore

590001

Sanofi-Aventis Investigational Site Number 356201, Belagavi

600086

Sanofi-Aventis Investigational Site Number 356205, Chennai

700515

Sanofi-Aventis Investigational Site Number 642203, Iași

7500010

Sanofi-Aventis Investigational Site Number 152202, Santiago

7980378

Sanofi-Aventis Investigational Site Number 152203, Santiago

8053095

Sanofi-Aventis Investigational Site Number 152206, Santiago

8360156

Sanofi-Aventis Investigational Site Number 152204, Santiago

8930211

Sanofi-Aventis Investigational Site Number 152205, Santiago

90035001

Sanofi-Aventis Investigational Site Number 076205, Porto Alegre

08750

Sanofi-Aventis Investigational Site Number 840231, Sea Girt

97201-3098

Sanofi-Aventis Investigational Site Number 840222, Portland

Unknown

Sanofi-Aventis Investigational Site Number 032204, Buenos Aires

Sanofi-Aventis Investigational Site Number 032211, Corrientes

Sanofi-Aventis Investigational Site Number 152201, Santiago

Sanofi-Aventis Investigational Site Number 170204, Barranquilla

Sanofi-Aventis Investigational Site Number 170201, Bogotá

Sanofi-Aventis Investigational Site Number 170202, Bogotá

Sanofi-Aventis Investigational Site Number 348207, Budapest

Sanofi-Aventis Investigational Site Number 356202, Bangalore

Sanofi-Aventis Investigational Site Number 356207, Kochi

Sanofi-Aventis Investigational Site Number 710203, Pretoria

Sanofi-Aventis Investigational Site Number 804202, Kyiv

C1056ABJ

Sanofi-Aventis Investigational Site Number 032209, Capital Federal

(E3100BBJ)

Sanofi-Aventis Investigational Site Number 032202, Paraná

66073-000

Sanofi-Aventis Investigational Site Number 076207, Belém

71625-009

Sanofi-Aventis Investigational Site Number 076202, Brasília

04024-002

Sanofi-Aventis Investigational Site Number 076204, São Paulo

L6R 3J5

Sanofi-Aventis Investigational Site Number 124219, Brampton

N7L 1C1

Sanofi-Aventis Investigational Site Number 124213, Chatham

V2P 4M9

Sanofi-Aventis Investigational Site Number 124208, Chilliwack

M9R 4E1

Sanofi-Aventis Investigational Site Number 124215, Etobicoke

G1V 4G5

Sanofi-Aventis Investigational Site Number 124205, Québec

T4N 6V7

Sanofi-Aventis Investigational Site Number 124202, Red Deer

L4J 8L7

Sanofi-Aventis Investigational Site Number 124218, Thornhill

M4R 2G4

Sanofi-Aventis Investigational Site Number 124201, Toronto

M9V 4B4

Sanofi-Aventis Investigational Site Number 124207, Toronto

V8V 4A1

Sanofi-Aventis Investigational Site Number 124209, Victoria

R3E 3P4

Sanofi-Aventis Investigational Site Number 124217, Winnipeg

01307

Sanofi-Aventis Investigational Site Number 276201, Dresden

1066 EC

Sanofi-Aventis Investigational Site Number 528203, Amsterdam

9728 NT

Sanofi-Aventis Investigational Site Number 528202, Groningen

3331 LZ

Sanofi-Aventis Investigational Site Number 528204, Zwijndrecht

31-548

Sanofi-Aventis Investigational Site Number 616202, Krakow

59-300

Sanofi-Aventis Investigational Site Number 616208, Lubin

24-100

Sanofi-Aventis Investigational Site Number 616207, Puławy

09-400

Sanofi-Aventis Investigational Site Number 616206, Płock

81-756

Sanofi-Aventis Investigational Site Number 616205, Sopot

70-506

Sanofi-Aventis Investigational Site Number 616201, Szczecin

41-8--

Sanofi-Aventis Investigational Site Number 616203, Zabrze

00717

Sanofi-Aventis Investigational Site Number 840226, Ponce

00917

Sanofi-Aventis Investigational Site Number 840216, San Juan

020725

Sanofi-Aventis Investigational Site Number 642208, Bucharest

413 45

Sanofi-Aventis Investigational Site Number 752204, Gothenburg

871 82

Sanofi-Aventis Investigational Site Number 752203, Härnösand

972 33

Sanofi-Aventis Investigational Site Number 752205, Luleå

211 52

Sanofi-Aventis Investigational Site Number 752202, Malmo

111 57

Sanofi-Aventis Investigational Site Number 752201, Stockholm