NCT03434119 - Efficacy and Safety of Soliqua Versus Lantus in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents | Biotech Hunter

Enrollment

241

Participants

Timeline

Start Date

February 20, 2018

Primary Completion Date

January 7, 2019

Study Completion Date

January 7, 2019

Conditions

Type 2 Diabetes Mellitus

Interventions

DRUG

Insulin glargine/Lixisenatide

Insulin glargine (100 units per milliliter \[U/mL\]) and lixisenatide (33 micrograms per milliliter \[mcg/mL\]) self administered by a subcutaneous injection using a prefilled pen. Dose was individually titrated to achieve target fasting self-monitoring of plasma glucose (SMPG) of 80 to 100 milligrams per deciliter (mg/dL) (4.4 to 5.6 millimoles per liter \[mmol/L\]) while avoiding hypoglycemia.

DRUG

Insulin glargine (HOE901)

Insulin glargine 100 U/mL self-administered by a subcutaneous injection using a prefilled pen. Dose was individually titrated to achieve target fasting SMPG of 80 to 100 mg/dL (4.4 to 5.6 mmol/L) while avoiding hypoglycemia.

DRUG

Background therapy

Oral Anti diabetics Drugs (OADs) administered orally according to the locally approved label.

Trial Locations (85)

10455

Investigational Site Number 8400003, The Bronx

19107

Investigational Site Number 8400062, Philadelphia

20110

Investigational Site Number 8400044, Manassas

20852

Investigational Site Number 8400061, Rockville

21237

Investigational Site Number 8400065, Baltimore

23219

Investigational Site Number 8400033, Richmond

23510

Investigational Site Number 8400068, Norfolk

29204

Investigational Site Number 8400043, Columbia

30303

Investigational Site Number 8400025, Atlanta

30310

Investigational Site Number 8400051, Atlanta

30318

Investigational Site Number 8400093, Atlanta

32204

Investigational Site Number 8400075, Jacksonville

32653

Investigational Site Number 8400041, Gainesville

33014

Investigational Site Number 8400016, Miami Lakes

33144

Investigational Site Number 8400036, Miami

33176

Investigational Site Number 8400017, Miami

33634

Investigational Site Number 8400094, Tampa

33713

Investigational Site Number 8400035, St. Petersburg

33952

Investigational Site Number 8400028, Port Charlotte

34761

Investigational Site Number 8400014, Ocoee

36106

Investigational Site Number 8400072, Montgomery

48118

Investigational Site Number 8400079, Chelsea

48504

Investigational Site Number 8400001, Flint

60018

Investigational Site Number 8400031, Des Plaines

60031

Investigational Site Number 8400057, Gurnee

60201

Investigational Site Number 8400064, Evanston

60607

Investigational Site Number 8400038, Chicago

Investigational Site Number 8400088, Chicago

70053

Investigational Site Number 8400030, Gretna

70124

Investigational Site Number 8400009, New Orleans

72204

Investigational Site Number 8400077, Little Rock

72205

Investigational Site Number 8400095, Little Rock

72211

Investigational Site Number 8400013, Little Rock

75230

Investigational Site Number 8400021, Dallas

75904

Investigational Site Number 8400096, Lufkin

76132

Investigational Site Number 8400040, Fort Worth

77089

Investigational Site Number 8400045, Houston

77338

Investigational Site Number 8400002, Humble

77372

Investigational Site Number 8400008, Splendora

77379

Investigational Site Number 8400055, Spring

77478

Investigational Site Number 8400070, Sugar Land

77479

Investigational Site Number 8400085, Sugar Land

77598

Investigational Site Number 8400059, Webster

78028

Investigational Site Number 8400039, Kerrville

78228

Investigational Site Number 8400027, San Antonio

78230

Investigational Site Number 8400083, San Antonio

80113

Investigational Site Number 8400054, Englewood

89117

Investigational Site Number 8400090, Las Vegas

89148

Investigational Site Number 8400082, Las Vegas

90017

Investigational Site Number 8400015, Los Angeles

90057

Investigational Site Number 8400011, Los Angeles

90094

Investigational Site Number 8400301, Los Angeles

Investigational Site Number 8400302, Los Angeles

Investigational Site Number 8400303, Los Angeles

Investigational Site Number 8400304, Los Angeles

90255

Investigational Site Number 8400092, Huntington Park

90703

Investigational Site Number 8400049, Cerritos

91405

Investigational Site Number 8400024, Van Nuys

91505

Investigational Site Number 8400060, Burbank

91730

Investigational Site Number 8400042, Rancho Cucamonga

91766

Investigational Site Number 8400084, Pomona

91767

Investigational Site Number 8400081, Pomona

91910

Investigational Site Number 8400078, Chula Vista

92025

Investigational Site Number 8400047, Escondido

92114

Investigational Site Number 8400091, San Diego

92591

Investigational Site Number 8400037, Temecula

92701

Investigational Site Number 8400074, Santa Ana

92708

Investigational Site Number 8400066, Fountain Valley

92801

Investigational Site Number 8400052, Anaheim

92805

Investigational Site Number 8400069, Anaheim

92868

Investigational Site Number 8400053, Orange

93003

Investigational Site Number 8400007, Ventura

94070

Investigational Site Number 8400063, San Carlos

94592

Investigational Site Number 8400087, Vallejo

94612

Investigational Site Number 8400048, Oakland

94904

Investigational Site Number 8400050, Greenbrae

95032

Investigational Site Number 8400006, Los Gatos

95148

Investigational Site Number 8400086, San Jose

99352

Investigational Site Number 8400029, Richland

92801-4123

Investigational Site Number 8400076, Anaheim

06517

Investigational Site Number 8400023, Hamden

00000

Investigational Site Number 8400097, St. Petersburg

31406-2675

Investigational Site Number 8400005, Savannah

48532-3447

Investigational Site Number 8400012, Flint

07036

Investigational Site Number 8400018, Linden