Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin

PHASE3CompletedINTERVENTIONAL
Enrollment

451

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

May 31, 2013

Study Completion Date

May 31, 2013

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Lixisenatide (AVE0010)

Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous

DEVICE

Self-injector pen device (OptiClik®)

DRUG

Metformin

To be kept at stable dose (≥1.5 g/day) throughout the study.

Trial Locations (82)

2091

Investigational Site Number 804102, Kiev

10000

Investigational Site Number 203102, Prague

10034

Investigational Site Number 203101, Prague

12808

Investigational Site Number 203105, Prague

13125

Investigational Site Number 276107, Berlin

15006

Investigational Site Number 724107, A Coruña

15403

Investigational Site Number 724102, Ferrol

29010

Investigational Site Number 724106, Málaga

32600

Investigational Site Number 203104, Pilsen

35614

Investigational Site Number 276103, Aßlar

35700

Investigational Site Number 250105, Rennes

36011

Investigational Site Number 804106, Poltava

40002

Investigational Site Number 724108, Segovia

41014

Investigational Site Number 724105, Seville

48504

Investigational Site Number 840120, Flint

54003

Investigational Site Number 804104, Mykolaiv

54101

Investigational Site Number 203103, Trutnov

58103

Investigational Site Number 840111, Fargo

59103

Investigational Site Number 840115, Billings

60611

Investigational Site Number 840122, Chicago

60616

Investigational Site Number 840119, Chicago

61002

Investigational Site Number 804108, Kharkiv

61022

Investigational Site Number 804105, Kharkiv

62704

Investigational Site Number 840114, Springfield

63000

Investigational Site Number 250108, Clermont-Ferrand

66386

Investigational Site Number 276108, Saint Ingbert-Oberwürzbach

69115

Investigational Site Number 276101, Heidelberg

69600

Investigational Site Number 804101, Zaporozhie

84088

Investigational Site Number 840110, West Jordan

85028

Investigational Site Number 840105, Phoenix

85213

Investigational Site Number 840113, Mesa

85282

Investigational Site Number 840102, Tempe

85306

Investigational Site Number 840112, Glendale

91325

Investigational Site Number 840103, Northridge

92014

Investigational Site Number 250103, Nanterre

92374

Investigational Site Number 840118, Redlands

92591

Investigational Site Number 840104, Temecula

92691

Investigational Site Number 840116, Mission Viejo

94550

Investigational Site Number 276104, Künzing

97980

Investigational Site Number 276102, Bad Mergentheim

100097

Investigational Site Number 642102, Ploieşti

119435

Investigational Site Number 643103, Moscow

125367

Investigational Site Number 643101, Moscow

194291

Investigational Site Number 643107, Saint Petersburg

194354

Investigational Site Number 643105, Saint Petersburg

195257

Investigational Site Number 643110, Saint Petersburg

300456

Investigational Site Number 642103, Timișoara

320076

Investigational Site Number 642104, Reşiţa

394018

Investigational Site Number 643104, Voronezh

410169

Investigational Site Number 642105, Oradea

443067

Investigational Site Number 643102, Samara

600023

Investigational Site Number 643108, Vladimir

603018

Investigational Site Number 643106, Nizhny Novgorod

Unknown

Investigational Site Number 840107, Tempe

08750

Investigational Site Number 840101, Sea Girt

L6R 3J5

Investigational Site Number 124102, Brampton

V3K 3P4

Investigational Site Number 124108, Coquitlam

M9R 4E1

Investigational Site Number 124106, Etobicoke

V1Y 1Z9

Investigational Site Number 124113, Kelowna

H7T 2P5

Investigational Site Number 124110, Laval

L3Y 5G8

Investigational Site Number 124103, Newmarket

L6H 3P1

Investigational Site Number 124101, Oakville

G6W 5M6

Investigational Site Number 124111, Saint Romuald

L4J 8L7

Investigational Site Number 124104, Thornhill

M9V 4B4

Investigational Site Number 124105, Toronto

V5Z 1M9

Investigational Site Number 124112, Vancouver

664 53

Investigational Site Number 203106, Újezd u Brna

06500

Investigational Site Number 250102, Menton

01796

Investigational Site Number 276105, Pirna

41-902

Investigational Site Number 616106, Bytom

80-858

Investigational Site Number 616102, Gdansk

31-450

Investigational Site Number 616101, Krakow

20-538

Investigational Site Number 616103, Lublin

32-600

Investigational Site Number 616108, Oświęcim

50-127

Investigational Site Number 616105, Wroclaw

50-306

Investigational Site Number 616104, Wroclaw

50-403

Investigational Site Number 616107, Wroclaw

050538

Investigational Site Number 642101, Bucharest

08020

Investigational Site Number 724104, Barcelona

08041

Investigational Site Number 724103, Barcelona

08550

Investigational Site Number 724101, Hostalets de Balenyà

04114

Investigational Site Number 804103, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY

NCT01517412 - Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin | Biotech Hunter | Biotech Hunter