Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin)

PHASE3CompletedINTERVENTIONAL
Enrollment

517

Participants

Timeline

Start Date

October 23, 2015

Primary Completion Date

April 3, 2017

Study Completion Date

April 3, 2017

Conditions
Hypercholesterolaemia
Interventions
DRUG

Alirocumab

Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector.

DRUG

Placebo

Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector.

DRUG

Lipid-Modifying Therapy (LMT)

Statins at stable, maximally tolerated dose with or without other LMT as clinically indicated.

DRUG

Antihyperglycemic Drug

Insulin (injectable or inhaled) alone or with other antihyperglycemic drugs as clinically indicated.

Trial Locations (110)

1160

Investigational Site Number 040001, Vienna

2650

Investigational Site Number 056002, Edegem

3000

Investigational Site Number 056001, Leuven

4021

Investigational Site Number 040005, Linz

4600

Investigational Site Number 756001, Olten

5020

Investigational Site Number 040003, Salzburg

5026

Investigational Site Number 040004, Salzburg

6020

Investigational Site Number 040002, Innsbruck

7100

Investigational Site Number 056003, Haine-Saint-Paul

9016

Investigational Site Number 756003, Sankt Gallen

10024

Investigational Site Number 380005, Moncalieri

10115

Investigational Site Number 276002, Berlin

11432

Investigational Site Number 840012, Jamaica

15405

Investigational Site Number 724006, Ferrol

17019

Investigational Site Number 250-004, La Rochelle

18003

Investigational Site Number 724013, Granada

20132

Investigational Site Number 380006, Milan

20162

Investigational Site Number 380007, Milan

20246

Investigational Site Number 276021, Hamburg

20782

Investigational Site Number 840013, Hyattsville

20852

Investigational Site Number 840016, Rockville

21339

Investigational Site Number 276013, Lüneburg

22041

Investigational Site Number 276018, Hamburg

22100

Investigational Site Number 380011, Como

24534

Investigational Site Number 276008, Neumünster

25030

Investigational Site Number 250-008, Besançon

26133

Investigational Site Number 276004, Oldenburg

28040

Investigational Site Number 724005, Madrid

28222

Investigational Site Number 724011, Majadahonda

29010

Investigational Site Number 724008, Málaga

29651

Investigational Site Number 840009, Greer

30076

Investigational Site Number 840021, Roswell

31008

Investigational Site Number 724002, Pamplona

31059

Investigational Site Number 250-001, Toulouse

32205

Investigational Site Number 840023, Jacksonville

33006

Investigational Site Number 724014, Oviedo

33180

Investigational Site Number 840006, Bradenton

33462

Investigational Site Number 840026, Atlantis

34684

Investigational Site Number 840028, Palm Harbor

37126

Investigational Site Number 380012, Verona

37404

Investigational Site Number 840024, Chattanooga

39120

Investigational Site Number 276022, Magdeburg

41071

Investigational Site Number 724003, Seville

43537

Investigational Site Number 840014, Maumee

44093

Investigational Site Number 250-002, Nantes

44137

Investigational Site Number 276011, Dortmund

46260

Investigational Site Number 840011, Indianapolis

46383

Investigational Site Number 840015, Valparaiso

50314

Investigational Site Number 840010, Des Moines

55416

Investigational Site Number 840004, Minneapolis

56124

Investigational Site Number 380001, Pisa

56564

Investigational Site Number 276017, Neuwied

62704

Investigational Site Number 840007, Springfield

63739

Investigational Site Number 276015, Aschaffenburg

66740

Investigational Site Number 276010, Saarlouis

67098

Investigational Site Number 250-006, Strasbourg

69115

Investigational Site Number 276005, Heidelberg

71200

Investigational Site Number 250-003, Le Creusot

75018

Investigational Site Number 250-007, Paris

75230

Investigational Site Number 840003, Dallas

75246

Investigational Site Number 840019, Dallas

77090

Investigational Site Number 840025, Houston

78756

Investigational Site Number 840001, Austin

80138

Investigational Site Number 380009, Napoli

80538

Investigational Site Number 840027, Loveland

84102

Investigational Site Number 840008, Salt Lake City

84405

Investigational Site Number 840017, Ogden

90127

Investigational Site Number 380002, Palermo

91100

Investigational Site Number 250-005, Corbeil-Essonnes

91436

Investigational Site Number 840020, Encino

92237

Investigational Site Number 276016, Sulzbach-Rosenberg

93720

Investigational Site Number 840002, Fresno

94612

Investigational Site Number 840029, Oakland

95122

Investigational Site Number 380004, Catania

Unknown

Investigational Site Number 840022, Ponte Vedra Beach

Investigational Site Number 840005, Louisville

Investigational Site Number 250-009, Mulhouse

Investigational Site Number 380003, Catanzaro

Investigational Site Number 380008, Padua

Investigational Site Number 528005, Groningen

Investigational Site Number 528004, Utrecht

Investigational Site Number 724004, Madrid

Investigational Site Number 724012, Segovia

04210

Investigational Site Number 840018, Auburn

01099

Investigational Site Number 276019, Dresden

01279

Investigational Site Number 276014, Dresden

01307

Investigational Site Number 276009, Dresden

01796

Investigational Site Number 276003, Pirna

01587

Investigational Site Number 276006, Riesa

00133

Investigational Site Number 380010, Roma

7334 DZ

Investigational Site Number 528002, Apeldoorn

7909AA

Investigational Site Number 528003, Hoogeveen

3045PM

Investigational Site Number 528001, Rotterdam

08915

Investigational Site Number 724007, Badalona

08025

Investigational Site Number 724001, Barcelona

07198

Investigational Site Number 724009, Palma de Mallorca

08970

Investigational Site Number 724010, Sant Joan Despí

ML60JS

Investigational Site Number 826010, Airdrie

BA13NG

Investigational Site Number 826011, Bath

BH77DW

Investigational Site Number 826009, Bournemouth

BD96RJ

Investigational Site Number 826005, Bradford

BS28HW

Investigational Site Number 826004, Bristol

DE13 0RB

Investigational Site Number 826001, Burton-on-Trent

DH15TW

Investigational Site Number 826015, Durham

HP112TT

Investigational Site Number 826012, High Wycombe

M239LT

Investigational Site Number 826007, Manchester

PE39QZ

Investigational Site Number 826006, Peterborough

SO303JB

Investigational Site Number 826003, Southampton

TR13LJ

Investigational Site Number 826008, Truro

AL74HQ

Investigational Site Number 826002, Welwyn Garden City

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY