Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 2 Diabetes Mellitus Patients (INSTRIDE 2)

PHASE3CompletedINTERVENTIONAL
Enrollment

560

Participants

Timeline

Start Date

August 31, 2014

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions
Type 2 Diabetes
Interventions
DRUG

Mylan's insulin glargine

Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.

DRUG

Lantus®

For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.

Trial Locations (120)

7646

Mylan Investigational Site, Cape Town

10301

Mylan Investigational Site, Staten Island

10530

Mylan Investigational Site, Hartsdale

11787

Mylan Investigational Site, Smithtown

12206

Mylan Investigational Site, Albany

20110

Mylan Investigational Site, Manassas

23321

Mylan Investigational Site, Chesapeake

27215

Mylan Investigational Site, Burlington

27408

Mylan Investigational Site, Greensboro

27513

Mylan Investigational Site, Cary

28401

Mylan Investigational Site, Wilmington

28557

Mylan Investigational Site, Morehead City

28590

Mylan Investigational Site, Greenville

28601

Mylan Investigational Site, Hickory

28803

Mylan Investigational Site, Asheville

29407

Mylan Investigational Site, Charleston

29651

Mylan Investigational Site, Greer

30501

Mylan Investigational Site, Gainesville

31904

Mylan Investigational Site, Columbus

33012

Mylan Investigational Site, Hialeah

33024

Mylan Investigational Site, Cooper City

33028

Mylan Investigational Site, Pembroke Pines

33142

Mylan Investigational Site, Miami

33156

Mylan Investigational Site, Miami

33401

Mylan Investigational Site, West Palm Beach

33880

Mylan Investigational Site, Winter Haven

33952

Mylan Investigational Site, Port Charlotte

34208

Mylan Investigational Site, Bradenton

Mylan Investigational Site, Bristol

34652

Mylan Investigational Site, New Port Richey

34684

Mylan Investigational Site, Palm Harbor

37660

Mylan Investigational Site, Kingsport

38119

Mylan Investigational Site, Memphis

40503

Mylan Investigational Site, Lexington

41017

Mylan Investigational Site, Crestview Hills

43201

Mylan Investigational Site, Columbus

44122

Mylan Investigational Site, Cleveland

45236

Mylan Investigational Site, Cincinnati

46011

Mylan Investigational Site, Anderson

47304

Mylan Investigational Site, National City

50314

Mylan Investigational Site, Des Moines

51501

Mylan Investigational Site, Council Bluffs

59101

Mylan Investigational Site, Billings

60012

Mylan Investigational Site, Crystal Lake

60616

Mylan Investigational Site, Chicago

62704

Mylan Investigational Site, Springfield

63128

Mylan Investigational Site, St Louis

64114

Mylan Investigational Site, Kansas City

66606

Mylan Investigational Site, Topeka

67010

Mylan Investigational Site, Augusta

67207

Mylan Investigational Site, Wichita

68114

Mylan Investigational Site, Omaha

68131

Mylan Investigational Site, Omaha

68516

Mylan Investigational Site, Lincoln

75070

Mylan Investigational Site, McKinney

75230

Mylan Investigational Site, Dallas

75231

Mylan Investigational Site, Dallas

77004

Mylan Investigational Site, Houston

77095

Mylan Investigational Site, Houston

77379

Mylan Investigational Site, Spring

77901

Mylan Investigational Site, Victoria

78258

Mylan Investigational Site, San Antonio

78404

Mylan Investigational Site, Corpus Christi

78681

Mylan Investigational Site, Round Rock

78731

Mylan Investigational Site, Austin

79925

Mylan Investigational Site, El Paso

83404

Mylan Investigational Site, Idaho Falls

84095

Mylan Investigational Site, South Jordan

84102

Mylan Investigational Site, Salt Lake City

84109

Mylan Investigational Site, Salt Lake City

84121

Mylan Investigational Site, Salt Lake City

84405

Mylan Investigational Site, Ogden

85224

Mylan Investigational Site, Chandler

89119

Mylan Investigational Site, Las Vegas

89128

Mylan Investigational Site, Las Vegas

90057

Mylan Investigational Site, Los Angeles

90201

Mylan Investigational Site, Bell Gardens

90807

Mylan Investigational Site, Long Beach

91307

Mylan Investigational Site, West Hills

91324

Mylan Investigational Site, Northridge

91345

Mylan Investigational Site, Mission Hills

91978

Mylan Investigational Site, Spring Valley

92262

Mylan Investigational Site, Palm Springs

92780

Mylan Investigational Site, Tustin

92868

Mylan Investigational Site, Orange

93720

Mylan Investigational Site, Fresno

94598

Mylan Investigational Site, Walnut Creek

94904

Mylan Investigational Site, Greenbrae

95032

Mylan Investigational Site, Los Gatos

96814

Mylan Investigational Site, Honolulu

97701

Mylan Investigational Site, Bend

98405

Mylan Investigational Site, Tacoma

Mylan Investigational Site, Vancouver

110744

Mylan Investigational Site, Seoul

02453

Mylan Investigational Site, Waltham

03063

Mylan Investigational Site, Nashua

Unknown

Mylan Investigational Site, Amman

Mylan Investigational Site, Irbid

Mylan Investigational Site, Banská Bystrica

Mylan Investigational Site, Bardejov

Mylan Investigational Site, Bratislava

Mylan Investigational Site, Dolný Kubín

Mylan Investigational Site, Košice

Mylan Investigational Site, Levice

Mylan Investigational Site, Sabinov

Mylan Investigational Site, Stropkov

Mylan Investigational Site, Šahy

Mylan Investigational Site, Štúrovo

Mylan Investigational Site, Trebišov

Mylan Investigational Site, Trenčín

Mylan Investigational Site, Žilina

Mylan Investigational Site, Johannesburg

Mylan Investigational Site, Durban

Mylan Investigational Site, Cape Town

Mylan Investigational Site, Worcester

Mylan Investigational Site, Bloemfontein

Mylan Investigational Site, Seoul

Mylan Investigational Site, Suwon

Mylan Investigational Site, Kaohsiung City

Mylan Investigational Site, Taipei

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Mylan GmbH

INDUSTRY

lead

Mylan Inc.

INDUSTRY