NCT00976937View on ClinicalTrials.gov

24-week Study Comparing Lixisenatide to Sitagliptin as add-on to Metformin in Obese Type 2 Diabetic Patients Younger Than 50 Years

PHASE3CompletedINTERVENTIONAL
Enrollment

319

Participants

Timeline

Start Date

August 31, 2009

Primary Completion Date

March 31, 2011

Study Completion Date

March 31, 2011

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Lixisenatide (AVE0010)

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

DRUG

Lixisenatide Placebo

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

DEVICE

Pen auto-injector

DRUG

Sitagliptin

Administered orally once a day in the morning with or without food at approximately the same time each day.

DRUG

Sitagliptin Placebo

Administered orally once a day in the morning with or without food at approximately the same time each day.

DRUG

Metformin

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

Trial Locations (92)

27

Sanofi-Aventis Investigational Site Number 604005, Lima

1010

Sanofi-Aventis Investigational Site Number 320004, Guatemala City

2006

Sanofi-Aventis Investigational Site Number 036003, Sydney

2091

Sanofi-Aventis Investigational Site Number 804001, Kiev

3128

Sanofi-Aventis Investigational Site Number 036001, Box Hill

3220

Sanofi-Aventis Investigational Site Number 036002, Geelong

4131

Sanofi-Aventis Investigational Site Number 036005, Meadowbrook

5000

Sanofi-Aventis Investigational Site Number 036006, Adelaide

5112

Sanofi-Aventis Investigational Site Number 036004, Elizabeth Vale

13125

Sanofi-Aventis Investigational Site Number 276002, Berlin

14050

Sanofi-Aventis Investigational Site Number 484011, México

16602

Sanofi-Aventis Investigational Site Number 840025, Altoona

20230

Sanofi-Aventis Investigational Site Number 484003, Aguascalientes

30076

Sanofi-Aventis Investigational Site Number 840007, Roswell

30909

Sanofi-Aventis Investigational Site Number 840021, Augusta

31000

Sanofi-Aventis Investigational Site Number 484010, Chihuahua City

31156

Sanofi-Aventis Investigational Site Number 804004, Kyiv

31238

Sanofi-Aventis Investigational Site Number 484009, Chihuahua City

35661

Sanofi-Aventis Investigational Site Number 840003, Muscle Shoals

36109

Sanofi-Aventis Investigational Site Number 840019, Montgomery

37207

Sanofi-Aventis Investigational Site Number 840009, Brentwood

42090

Sanofi-Aventis Investigational Site Number 484001, Pachuca

Sanofi-Aventis Investigational Site Number 484005, Pachuca

43551

Sanofi-Aventis Investigational Site Number 840026, Perrysburg

44030

Sanofi-Aventis Investigational Site Number 484002, Zapopan

47714

Sanofi-Aventis Investigational Site Number 840001, Evansville

48346

Sanofi-Aventis Investigational Site Number 840031, Clarkston

58022

Sanofi-Aventis Investigational Site Number 804003, Chernivtsi

59701

Sanofi-Aventis Investigational Site Number 840006, Butte

60610

Sanofi-Aventis Investigational Site Number 840016, Chicago

60616

Sanofi-Aventis Investigational Site Number 840018, Chicago

63031

Sanofi-Aventis Investigational Site Number 840020, Florissant

67059

Sanofi-Aventis Investigational Site Number 276005, Ludwigshafen

70808

Sanofi-Aventis Investigational Site Number 840002, Baton Rouge

75230

Sanofi-Aventis Investigational Site Number 840008, Dallas

78229

Sanofi-Aventis Investigational Site Number 840010, San Antonio

85206

Sanofi-Aventis Investigational Site Number 840022, Mesa

90723

Sanofi-Aventis Investigational Site Number 840014, Paramount

91700

Sanofi-Aventis Investigational Site Number 484006, Veracruz

92374

Sanofi-Aventis Investigational Site Number 840027, Redlands

92801

Sanofi-Aventis Investigational Site Number 840011, Anaheim

97000

Sanofi-Aventis Investigational Site Number 484008, Mérida

97504

Sanofi-Aventis Investigational Site Number 840004, Medford

100097

Sanofi-Aventis Investigational Site Number 642009, Ploieşti

194358

Sanofi-Aventis Investigational Site Number 643001, Saint Petersburg

195257

Sanofi-Aventis Investigational Site Number 643003, Saint Petersburg

198013

Sanofi-Aventis Investigational Site Number 643005, Saint Petersburg

300593

Sanofi-Aventis Investigational Site Number 642007, Timișoara

320076

Sanofi-Aventis Investigational Site Number 642001, Reşiţa

420012

Sanofi-Aventis Investigational Site Number 643002, Kazan'

600164

Sanofi-Aventis Investigational Site Number 642004, Bacau

625023

Sanofi-Aventis Investigational Site Number 643004, Tyumen

700515

Sanofi-Aventis Investigational Site Number 642010, Iași

720262

Sanofi-Aventis Investigational Site Number 642005, Suceava

7500347

Sanofi-Aventis Investigational Site Number 152001, Santiago

7500710

Sanofi-Aventis Investigational Site Number 152004, Santiago

8053095

Sanofi-Aventis Investigational Site Number 152003, Santiago

66073-000

Sanofi-Aventis Investigational Site Number 076005, Belém

71625-009

Sanofi-Aventis Investigational Site Number 076001, Brasília

95070-560

Sanofi-Aventis Investigational Site Number 076006, Caxias do Sul

80060-900

Sanofi-Aventis Investigational Site Number 076003, Curitiba

20211-340

Sanofi-Aventis Investigational Site Number 076002, Rio de Janeiro

04024-002

Sanofi-Aventis Investigational Site Number 076004, São Paulo

05403-000

Sanofi-Aventis Investigational Site Number 076007, São Paulo

T2N 4N1

Sanofi-Aventis Investigational Site Number 124004, Calgary

L8L 5G8

Sanofi-Aventis Investigational Site Number 124008, Hamilton

N6G 2M3

Sanofi-Aventis Investigational Site Number 124005, London

H2W 1R7

Sanofi-Aventis Investigational Site Number 124006, Montreal

L6H 3P1

Sanofi-Aventis Investigational Site Number 124013, Oakville

G6W 5M6

Sanofi-Aventis Investigational Site Number 124002, Saint Romuald

L4J 8L7

Sanofi-Aventis Investigational Site Number 124012, Thornhill

Unknown

Sanofi-Aventis Investigational Site Number 124011, Toronto

Sanofi-Aventis Investigational Site Number 152002, Santiago

Sanofi-Aventis Investigational Site Number 152005, Santiago

Sanofi-Aventis Investigational Site Number 320005, Guatemala City

Sanofi-Aventis Investigational Site Number 320006, Guatemala City

Sanofi-Aventis Investigational Site Number 604001, Lima

Sanofi-Aventis Investigational Site Number 604002, Lima

Sanofi-Aventis Investigational Site Number 604004, Lima

V5Z 1C6

Sanofi-Aventis Investigational Site Number 124003, Vancouver

V8R 6V4

Sanofi-Aventis Investigational Site Number 124007, Victoria

04435

Sanofi-Aventis Investigational Site Number 276004, Schkeuditz

01010

Sanofi-Aventis Investigational Site Number 320002, Guatemala City

01014

Sanofi-Aventis Investigational Site Number 320001, Guatemala City

03300

Sanofi-Aventis Investigational Site Number 484012, Df

Lima 27

Sanofi-Aventis Investigational Site Number 604003, Lima

15-435

Sanofi-Aventis Investigational Site Number 616002, Bialystok

85-822

Sanofi-Aventis Investigational Site Number 616001, Bydgoszcz

02-507

Sanofi-Aventis Investigational Site Number 616006, Warsaw

50-127

Sanofi-Aventis Investigational Site Number 616003, Wroclaw

020475

Sanofi-Aventis Investigational Site Number 642006, Bucharest

022441

Sanofi-Aventis Investigational Site Number 642008, Bucharest

Sponsors

Lead Sponsor

Sanofi
All Listed Sponsors
lead

Sanofi

INDUSTRY