A Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo Versus Lantus in Patients With Type 1 Diabetes Mellitus

PHASE4CompletedINTERVENTIONAL
Enrollment

638

Participants

Timeline

Start Date

May 5, 2016

Primary Completion Date

June 19, 2017

Study Completion Date

June 19, 2017

Conditions
Type 1 Diabetes Mellitus
Interventions
DRUG

HOE901-U300 (Insulin Glargine 300 U/ml)

Self-administered by subcutaneous (SC) injection in the morning (between waking up and breakfast) using a pre-filled pen.

DRUG

Lantus (Insulin Glargine 100 U/ml)

Self-administered by subcutaneous (SC) injection in the morning (between waking up and breakfast using a pre-filled pen.

DRUG

Mandated back ground therapy

Rapid insulin analogs: e.g., insulin glulisine, insulin lispro or insulin aspart, used by participant at least 30 days before screening. Mealtime insulin was to be continued during the study and titrated towards protocol specified postprandial glucose targets (130-180 mg/dL).

Trial Locations (100)

10001

Investigational Site Number 840-102, New York

10029

Investigational Site Number 840-108, New York

20782

Investigational Site Number 840-054, Hyattsville

20852

Investigational Site Number 840-006, Rockville

26330

Investigational Site Number 840-139, Bridgeport

27834

Investigational Site Number 840-045, Greenville

28557

Investigational Site Number 840-010, Morehead City

Investigational Site Number 840-080, Morehead City

30046

Investigational Site Number 840-012, Lawrenceville

30076

Investigational Site Number 840-008, Roswell

30281

Investigational Site Number 840-014, Stockbridge

30318

Investigational Site Number 840-001, Atlanta

31904

Investigational Site Number 840-064, Columbus

32174

Investigational Site Number 840-112, Ormond Beach

32751

Investigational Site Number 840-137, Maitland

33016

Investigational Site Number 840-133, Hialeah

33124

Investigational Site Number 840-072, Coral Gables

33155

Investigational Site Number 840-049, Miami

33176

Investigational Site Number 840-076, Miami

33401

Investigational Site Number 840-036, West Palm Beach

33612

Investigational Site Number 840-114, Tampa

33952

Investigational Site Number 840-047, Port Charlotte

34652

Investigational Site Number 840-023, New Port Richey

34684

Investigational Site Number 840-018, Palm Harbor

34761

Investigational Site Number 840-053, Ocoee

37411

Investigational Site Number 840-058, Chattanooga

40503

Investigational Site Number 840-042, Lexington

41011

Investigational Site Number 840-062, Covington

43203

Investigational Site Number 840-123, Columbus

44060

Investigational Site Number 840-104, Mentor

48532

Investigational Site Number 840-037, Flint

50265

Investigational Site Number 840-002, West Des Moines

58103

Investigational Site Number 840-051, Fargo

59101

Investigational Site Number 840-067, Billings

60005

Investigational Site Number 840-125, Arlington Heights

60012

Investigational Site Number 840-134, Crystal Lake

60612

Investigational Site Number 840-011, Chicago

67226

Investigational Site Number 840-073, Wichita

68114

Investigational Site Number 840-033, Omaha

68124

Investigational Site Number 840-142, Omaha

68526

Investigational Site Number 840-094, Lincoln

70006

Investigational Site Number 840-009, Metairie

70115

Investigational Site Number 840-032, New Orleans

72205

Investigational Site Number 840-151, Little Rock

73069

Investigational Site Number 840-079, Norman

75149

Investigational Site Number 840-029, Mesquite

75230

Investigational Site Number 840-003, Dallas

75231

Investigational Site Number 840-019, Dallas

75235

Investigational Site Number 840-075, Dallas

75246

Investigational Site Number 840-005, Dallas

Investigational Site Number 840-013, Dallas

75904

Investigational Site Number 840-140, Lufkin

76132

Investigational Site Number 840-026, Fort Worth

76180

Investigational Site Number 840-048, North Richland Hills

77024

Investigational Site Number 840-081, Houston

77043

Investigational Site Number 840-160, Houston

77079

Investigational Site Number 840-156, Houston

77089

Investigational Site Number 840-152, Houston

77095

Investigational Site Number 840-031, Houston

77584

Investigational Site Number 840-150, Pearland

79925

Investigational Site Number 840-153, El Paso

80113

Investigational Site Number 840-046, Englewood

80209

Investigational Site Number 840-039, Denver

80246

Investigational Site Number 840-021, Denver

80262

Investigational Site Number 840-070, Denver

83404

Investigational Site Number 840-060, Idaho Falls

84102

Investigational Site Number 840-097, Salt Lake City

84123

Investigational Site Number 840-083, Murray

84405

Investigational Site Number 840-101, Ogden

89052

Investigational Site Number 840-040, Henderson

89148

Investigational Site Number 840-017, Las Vegas

90036

Investigational Site Number 840-044, Los Angeles

90057

Investigational Site Number 840-022, Los Angeles

90274

Investigational Site Number 840-132, Rolling Hills Estates

91325

Investigational Site Number 840-024, Northridge

91356

Investigational Site Number 840-063, Tarzana

91766

Investigational Site Number 840-069, Pomona

91767

Investigational Site Number 840-090, Pomona

91942

Investigational Site Number 840-030, La Mesa

92025

Investigational Site Number 840-149, Escondido

92037

Investigational Site Number 840-124, La Jolla

93003

Investigational Site Number 840-016, Ventura

93720

Investigational Site Number 840-004, Fresno

94583

Investigational Site Number 840-055, San Ramon

94904

Investigational Site Number 840-110, Greenbrae

95032

Investigational Site Number 840-129, Los Gatos

95148

Investigational Site Number 840-130, San Jose

97210

Investigational Site Number 840-096, Portland

97702

Investigational Site Number 840-162, Bend

98055

Investigational Site Number 840-015, Renton

99207

Investigational Site Number 840-074, Spokane

94520-2270

Investigational Site Number 840-071, Concord

Unknown

Investigational Site Number 840-028, Santa Barbara

92780-6953

Investigational Site Number 840-138, Tustin

01702

Investigational Site Number 840-157, Framingham

02453

Investigational Site Number 840-122, Waltham

10301-3914

Investigational Site Number 840-109, Staten Island

05201

Investigational Site Number 840-143, Bennington

05405

Investigational Site Number 840-056, Burlington

00674

Investigational Site Number 840-111, Manatí

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY