Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients With Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM-Dyslipidemia)

PHASE4CompletedINTERVENTIONAL
Enrollment

413

Participants

Timeline

Start Date

March 15, 2016

Primary Completion Date

March 22, 2017

Study Completion Date

May 15, 2017

Conditions
Dyslipidemia
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

Statins

Statins at stable dose without other LMT as clinically indicated.

DRUG

Ezetimibe

Pharmaceutical form: tablet Route of administration: oral

DRUG

Fenofibrate

Pharmaceutical form: tablet Route of administration: oral

DRUG

Nicotinic acid

Pharmaceutical form: tablet Route of administration: oral

DRUG

Omega-3 fatty acids

Pharmaceutical form: tablet Route of administration: oral

DRUG

Antihyperglycemic Drug

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

Trial Locations (119)

1205

Investigational Site Number 756101, Geneva

2065

Investigational Site Number 036101, St Leonards

2291

Investigational Site Number 036104, Merewether

4006

Investigational Site Number 036102, Herston

4153

Investigational Site Number 756103, Reinach

4545

Investigational Site Number 784101, Dubai

4600

Investigational Site Number 756102, Olten

10016

Investigational Site Number 840-181, New York

10029

Investigational Site Number 840-157, New York

10126

Investigational Site Number 380102, Torino

12206

Investigational Site Number 840-178, Albany

13347

Investigational Site Number 276112, Berlin

13353

Investigational Site Number 276109, Berlin

14186

Investigational Site Number 752101, Stockholm

20852

Investigational Site Number 840-151, Rockville

23249

Investigational Site Number 840-171, Richmond

23321

Investigational Site Number 840-126, Chesapeake

23758

Investigational Site Number 276102, Oldenburg in Holstein

24127

Investigational Site Number 380104, Bergamo

27408

Investigational Site Number 840-188, Greensboro

28557

Investigational Site Number 840-131, Morehead City

28655

Investigational Site Number 840-158, Morganton

29485

Investigational Site Number 840-111, Summerville

30281

Investigational Site Number 840-169, Stockbridge

31030

Investigational Site Number 792109, Hatay

31904

Investigational Site Number 840-128, Columbus

32765

Investigational Site Number 840-179, Oviedo

33434

Investigational Site Number 840-107, Boca Raton

33472

Investigational Site Number 840-170, Boynton Beach

33520

Investigational Site Number 246104, Tampere

33634

Investigational Site Number 840-123, Tampa

34201

Investigational Site Number 840-114, Bradenton

34761

Investigational Site Number 840-132, Ocoee

35100

Investigational Site Number 380108, Padua

35340

Investigational Site Number 792104, Izmir

37404

Investigational Site Number 840-147, Chattanooga

37920

Investigational Site Number 840-159, Knoxville

38039

Investigational Site Number 792107, Kayseri

39819

Investigational Site Number 840-137, Bainbridge

41345

Investigational Site Number 752102, Gothenburg

42003

Investigational Site Number 840-183, Paducah

43213

Investigational Site Number 840-104, Columbus

43302

Investigational Site Number 840-105, Marion

43537

Investigational Site Number 840-175, Maumee

45355

Investigational Site Number 276110, Essen

45359

Investigational Site Number 276108, Essen

47574

Investigational Site Number 276111, Goch

56124

Investigational Site Number 380101, Pisa

58103

Investigational Site Number 840-129, Fargo

60012

Investigational Site Number 840-184, Crystal Lake

60201

Investigational Site Number 840-174, Evanston

60607

Investigational Site Number 840-161, Chicago

62711

Investigational Site Number 840-138, Springfield

63110

Investigational Site Number 840-120, St Louis

65109

Investigational Site Number 840-113, Jefferson City

70006

Investigational Site Number 840-190, Metairie

72205

Investigational Site Number 840-163, Little Rock

75230

Investigational Site Number 840-153, Dallas

76199

Investigational Site Number 276107, Karlsruhe

77095

Investigational Site Number 840-143, Houston

77099

Investigational Site Number 840-168, Houston

77375

Investigational Site Number 840-133, Tomball

78681

Investigational Site Number 840-142, Round Rock

80131

Investigational Site Number 380103, Napoli

83404

Investigational Site Number 840-167, Idaho Falls

84058

Investigational Site Number 840-185, Orem

84102

Investigational Site Number 840-150, Salt Lake City

88100

Investigational Site Number 380107, Catanzaro

89119

Investigational Site Number 840-101, Las Vegas

89128

Investigational Site Number 840-140, Las Vegas

90047

Investigational Site Number 380106, Partinico

90057

Investigational Site Number 840-118, Los Angeles

90100

Investigational Site Number 246102, Oulu

90220

Investigational Site Number 246101, Oulu

91325

Investigational Site Number 840-106, Northridge

91356

Investigational Site Number 840-122, Tarzana

91405

Investigational Site Number 840-160, Van Nuys

92037

Investigational Site Number 840-115, La Jolla

92648

Investigational Site Number 840-152, Huntington Beach

93041

Investigational Site Number 840-176, Port Hueneme

93720

Investigational Site Number 840-141, Fresno

94550

Investigational Site Number 276103, Künzing

97702

Investigational Site Number 840-136, Bend

13060080

Investigational Site Number 076103, Campinas

92780-6953

Investigational Site Number 840-156, Tustin

Unknown

Investigational Site Number 840-108, Louisville

Investigational Site Number 076102, São Paulo

Investigational Site Number 376101, Beersheba

Investigational Site Number 376103, Petah Tikva

Investigational Site Number 376104, Petah Tikva

Investigational Site Number 376102, Rehovot

Investigational Site Number 376106, Tel Aviv

Investigational Site Number 414101, Kuwait City

Investigational Site Number 422101, Beirut

Investigational Site Number 422102, Hazmiyeh

Investigational Site Number 792102, Ankara

Investigational Site Number 792108, Çorum

Investigational Site Number 792101, Izmir

Investigational Site Number 792110, Izmir

Investigational Site Number 792103, Samsun

68131-2137

Investigational Site Number 840-148, Omaha

29576-9351

Investigational Site Number 840-187, Murrells Inlet

60115-282

Investigational Site Number 076104, Fortaleza

01223-001

Investigational Site Number 076105, São Paulo

04040-001

Investigational Site Number 076101, São Paulo

05403-900

Investigational Site Number 076106, São Paulo

01744

Investigational Site Number 276104, Dippoldiswalde

01307

Investigational Site Number 276101, Dresden

00168

Investigational Site Number 380105, Roma

0372

Investigational Site Number 578101, Oslo

0407

Investigational Site Number 578102, Oslo

01250

Investigational Site Number 792105, Adana

06100

Investigational Site Number 792106, Ankara

EX25DW

Investigational Site Number 826104, Exeter

m139wl

Investigational Site Number 826106, Manchester

TS4 3BW

Investigational Site Number 826105, Middlesbrough

SG14AB

Investigational Site Number 826103, Stevenage

TQ27AA

Investigational Site Number 826101, Torquay

B714HJ

Investigational Site Number 826102, West Bromwich

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY

NCT02642159 - Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients With Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM-Dyslipidemia) | Biotech Hunter | Biotech Hunter