GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Pioglitazone

PHASE3CompletedINTERVENTIONAL
Enrollment

484

Participants

Timeline

Start Date

September 30, 2008

Primary Completion Date

June 30, 2011

Study Completion Date

June 30, 2011

Conditions
Diabetes Mellitus Type 2
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.

DEVICE

Pen auto-injector

DRUG

Pioglitazone

Dose to be kept stable.

DRUG

Metformin

Metformin, if given to be continued at stable dose (at least 1.5 gram per day) up to the end of treatment.

Trial Locations (150)

1030

Sanofi-Aventis Investigational Site Number 040702, Vienna

1060

Sanofi-Aventis Investigational Site Number 040704, Vienna

1100

Sanofi-Aventis Investigational Site Number 040701, Vienna

Sanofi-Aventis Investigational Site Number 040705, Vienna

2747

Sanofi-Aventis Investigational Site Number 840851, Russells Mills

4600

Sanofi-Aventis Investigational Site Number 040707, Wels

8036

Sanofi-Aventis Investigational Site Number 040706, Graz

10010

Sanofi-Aventis Investigational Site Number 840865, New York

10021

Sanofi-Aventis Investigational Site Number 840766, New York

10115

Sanofi-Aventis Investigational Site Number 276704, Berlin

10301

Sanofi-Aventis Investigational Site Number 840874, Staten Island

10552

Sanofi-Aventis Investigational Site Number 300705, Athens

14224

Sanofi-Aventis Investigational Site Number 840762, West Seneca

15009

Sanofi-Aventis Investigational Site Number 840751, Beaver

17019

Sanofi-Aventis Investigational Site Number 250707, La Rochelle

17356

Sanofi-Aventis Investigational Site Number 840798, Red Lion

20475

Sanofi-Aventis Investigational Site Number 642714, Bucharest

20783

Sanofi-Aventis Investigational Site Number 840764, Hyattsville

20850

Sanofi-Aventis Investigational Site Number 840871, Rockville

23220

Sanofi-Aventis Investigational Site Number 840752, Richmond

23502

Sanofi-Aventis Investigational Site Number 840757, Virginia Beach

23510

Sanofi-Aventis Investigational Site Number 840753, Norfolk

Sanofi-Aventis Investigational Site Number 840770, Norfolk

27215

Sanofi-Aventis Investigational Site Number 840747, Burlington

27262

Sanofi-Aventis Investigational Site Number 840712, High Point

27401

Sanofi-Aventis Investigational Site Number 840760, Greensboro

29201

Sanofi-Aventis Investigational Site Number 840792, Columbia

29681

Sanofi-Aventis Investigational Site Number 840740, Simpsonville

30909

Sanofi-Aventis Investigational Site Number 840857, Augusta

31860

Sanofi-Aventis Investigational Site Number 250705, Labarthe-sur-Lèze

32216

Sanofi-Aventis Investigational Site Number 840727, Jacksonville

32765

Sanofi-Aventis Investigational Site Number 840761, Oviedo

33414

Sanofi-Aventis Investigational Site Number 840799, Wellington

34652

Sanofi-Aventis Investigational Site Number 840745, New Port Richey

35205

Sanofi-Aventis Investigational Site Number 840723, Birmingham

Sanofi-Aventis Investigational Site Number 840744, Birmingham

35235

Sanofi-Aventis Investigational Site Number 840867, Birmingham

35242

Sanofi-Aventis Investigational Site Number 840720, Birmingham

35614

Sanofi-Aventis Investigational Site Number 276708, Aßlar

36608

Sanofi-Aventis Investigational Site Number 840855, Mobile

Sanofi-Aventis Investigational Site Number 840863, Mobile

37620

Sanofi-Aventis Investigational Site Number 840711, Bristol

39466

Sanofi-Aventis Investigational Site Number 840717, Picayune

40503

Sanofi-Aventis Investigational Site Number 840789, Lexington

40504

Sanofi-Aventis Investigational Site Number 840850, Lexington

44030

Sanofi-Aventis Investigational Site Number 484704, Zapopan

44060

Sanofi-Aventis Investigational Site Number 840709, Mentor

44122

Sanofi-Aventis Investigational Site Number 840741, Cleveland

45458

Sanofi-Aventis Investigational Site Number 840728, Dayton

45701

Sanofi-Aventis Investigational Site Number 840777, Athens

46123

Sanofi-Aventis Investigational Site Number 840738, Avon

46260

Sanofi-Aventis Investigational Site Number 840794, Indianapolis

49001

Sanofi-Aventis Investigational Site Number 840708, Kalamazoo

53160

Sanofi-Aventis Investigational Site Number 484701, Tlalnepantla

55122

Sanofi-Aventis Investigational Site Number 840704, Eagan

55435

Sanofi-Aventis Investigational Site Number 840774, Bloomington

56429

Sanofi-Aventis Investigational Site Number 300701, Thessaloniki

58103

Sanofi-Aventis Investigational Site Number 840877, Fargo

58501

Sanofi-Aventis Investigational Site Number 840780, Bismarck

59427

Sanofi-Aventis Investigational Site Number 250704, Armentières

60611

Sanofi-Aventis Investigational Site Number 840791, Chicago

63104

Sanofi-Aventis Investigational Site Number 840765, St Louis

66043

Sanofi-Aventis Investigational Site Number 840779, Lansing

67091

Sanofi-Aventis Investigational Site Number 250701, Strasbourg

67203

Sanofi-Aventis Investigational Site Number 840739, Wichita

70808

Sanofi-Aventis Investigational Site Number 840862, Baton Rouge

71101

Sanofi-Aventis Investigational Site Number 840879, Shreveport

71200

Sanofi-Aventis Investigational Site Number 250702, Le Creusot

72432

Sanofi-Aventis Investigational Site Number 840729, Harrisburg

72653

Sanofi-Aventis Investigational Site Number 840776, Mountain Home

73069

Sanofi-Aventis Investigational Site Number 840716, Norman

76034

Sanofi-Aventis Investigational Site Number 840853, Colleyville

77030

Sanofi-Aventis Investigational Site Number 840730, Houston

78218

Sanofi-Aventis Investigational Site Number 840854, San Antonio

80907

Sanofi-Aventis Investigational Site Number 840872, Colorado Springs

80909

Sanofi-Aventis Investigational Site Number 840868, Colorado Springs

83404

Sanofi-Aventis Investigational Site Number 840724, Idaho Falls

84015

Sanofi-Aventis Investigational Site Number 840796, Clinton

84102

Sanofi-Aventis Investigational Site Number 840755, Salt Lake City

84107

Sanofi-Aventis Investigational Site Number 840756, Salt Lake City

Sanofi-Aventis Investigational Site Number 840758, Salt Lake City

85050

Sanofi-Aventis Investigational Site Number 840769, Phoenix

85213

Sanofi-Aventis Investigational Site Number 840722, Mesa

85224

Sanofi-Aventis Investigational Site Number 840775, Chandler

89048

Sanofi-Aventis Investigational Site Number 840866, Pahrump

89119

Sanofi-Aventis Investigational Site Number 840875, Las Vegas

90701

Sanofi-Aventis Investigational Site Number 840795, Artesia

91307

Sanofi-Aventis Investigational Site Number 840763, West Hills

91325

Sanofi-Aventis Investigational Site Number 840733, Northridge

91345

Sanofi-Aventis Investigational Site Number 840773, Mission Hills

91710

Sanofi-Aventis Investigational Site Number 840782, Chino

92037

Sanofi-Aventis Investigational Site Number 840858, La Jolla

92123

Sanofi-Aventis Investigational Site Number 840772, San Diego

92237

Sanofi-Aventis Investigational Site Number 276702, Sulzbach-Rosenberg

92648

Sanofi-Aventis Investigational Site Number 840785, Huntington Beach

92691

Sanofi-Aventis Investigational Site Number 840707, Mission Viejo

93635

Sanofi-Aventis Investigational Site Number 840784, Los Banos

94401

Sanofi-Aventis Investigational Site Number 840743, San Mateo

94550

Sanofi-Aventis Investigational Site Number 276703, Künzing

95204

Sanofi-Aventis Investigational Site Number 840721, Stockton

95661

Sanofi-Aventis Investigational Site Number 840864, Roseville

97000

Sanofi-Aventis Investigational Site Number 484703, Mérida

97072

Sanofi-Aventis Investigational Site Number 276701, Würzburg

97504

Sanofi-Aventis Investigational Site Number 840701, Medford

99209

Sanofi-Aventis Investigational Site Number 840735, Spokane

100097

Sanofi-Aventis Investigational Site Number 642703, Ploieşti

300456

Sanofi-Aventis Investigational Site Number 642715, Timișoara

300593

Sanofi-Aventis Investigational Site Number 642710, Timișoara

320076

Sanofi-Aventis Investigational Site Number 642713, Reşiţa

430031

Sanofi-Aventis Investigational Site Number 642709, Baia Mare

440012

Sanofi-Aventis Investigational Site Number 356704, Nagpur

440055

Sanofi-Aventis Investigational Site Number 642708, Satu Mare

500001

Sanofi-Aventis Investigational Site Number 356702, Hyderabad

500326

Sanofi-Aventis Investigational Site Number 642701, Brasov

540061

Sanofi-Aventis Investigational Site Number 642706, Târgu Mureş

560010

Sanofi-Aventis Investigational Site Number 356701, Bangalore

560052

Sanofi-Aventis Investigational Site Number 356703, Bangalore

600164

Sanofi-Aventis Investigational Site Number 642702, Bacau

800575

Sanofi-Aventis Investigational Site Number 642707, Galati

900591

Sanofi-Aventis Investigational Site Number 642705, Constanța

66160-7321

Sanofi-Aventis Investigational Site Number 840767, Kansas City

29687-4105

Sanofi-Aventis Investigational Site Number 840726, Taylors

P3E 2P2

Sanofi-Aventis Investigational Site Number 124716, Greater Sudbury

N6A 5R8

Sanofi-Aventis Investigational Site Number 124710, London

J7J 2K8

Sanofi-Aventis Investigational Site Number 124712, Mirabel

G6W 5M6

Sanofi-Aventis Investigational Site Number 124705, Saint Romuald

S7K 3H3

Sanofi-Aventis Investigational Site Number 124703, Saskatoon

M1E 5E9

Sanofi-Aventis Investigational Site Number 124713, Scarborough

J1H 5N4

Sanofi-Aventis Investigational Site Number 124711, Sherbrooke

K7A 4W8

Sanofi-Aventis Investigational Site Number 124704, Smiths Falls

L4J 8L7

Sanofi-Aventis Investigational Site Number 124701, Thornhill

V5Z 1C6

Sanofi-Aventis Investigational Site Number 124708, Vancouver

04103

Sanofi-Aventis Investigational Site Number 276706, Leipzig

01796

Sanofi-Aventis Investigational Site Number 276707, Pirna

Unknown

Sanofi-Aventis Investigational Site Number 300703, Athens

Sanofi-Aventis Investigational Site Number 300704, Athens

Sanofi-Aventis Investigational Site Number 320703, Guatemala City

Sanofi-Aventis Investigational Site Number 320704, Guatemala City

Sanofi-Aventis Investigational Site Number 604702, Lima

Sanofi-Aventis Investigational Site Number 604705, Lima

Sanofi-Aventis Investigational Site Number 792702, Erzurum

Sanofi-Aventis Investigational Site Number 792705, Istanbul

01010

Sanofi-Aventis Investigational Site Number 320702, Guatemala City

01014

Sanofi-Aventis Investigational Site Number 320701, Guatemala City

Lima 27

Sanofi-Aventis Investigational Site Number 604703, Lima

LIMA 31

Sanofi-Aventis Investigational Site Number 604701, Lima

00983

Sanofi-Aventis Investigational Site Number 630714, Carolina

Sanofi-Aventis Investigational Site Number 630715, Carolina

510 217

Sanofi-Aventis Investigational Site Number 642711, Alba Iulia

010507

Sanofi-Aventis Investigational Site Number 642712, Bucharest

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY