Efficacy and Safety in Subjects With Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-up

PHASE3CompletedINTERVENTIONAL
Enrollment

677

Participants

Timeline

Start Date

February 28, 2006

Primary Completion Date

August 31, 2008

Study Completion Date

September 30, 2008

Conditions
Diabetes Type 2
Interventions
DRUG

Technosphere® Insulin Inhalation Powder

Inhalation, 15U/30U

DRUG

70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)

BPR 70/30, which is a premix of intermediate acting and rapid acting insulin given sc

Trial Locations (151)

4000

CITDEEM - Centro de Investigacion y Tratamiento En Diabetes y Enfermedades Endocrino-Metabolicas, San Miguel de Tucumán

10301

Univeristy of Physicians Group Endocrine Division, Staten Island

11042

North Shore Diabetes and Endocrine Associates, New Hyde Park

11501

Winthrop University Hospital, Mineola

19020

Pennsylvania Research Institute, Bensalem

19107

Thomas Jefferson University, Philadelphia

21201

Joslin Diabetes Center University of Maryland Medicine, Baltimore

21204

James A Dicke MDPA, Towson

23502

Sentara Medical Group, Norfolk

23507

Clinical Research Associates of Tidewater, Norfolk

27834

East Carolina University (Tanenberg), Greenville

Physician's East PA, Greenville

28006

Hospital Universitario de la Princessa, Madrid

28034

Hospital Ramon y Cajal, Madrid

28277

Sensenbrenner Primary Care, Charlotte

29615

Upstate Pharmaceutical Research, Greenville

29687

Southeastern Research Associates Inc, Taylors

30045

North Atlanta Endocrinology & Diabetes PC, Lawrenceville

30075

Atlanta Center for Clinical Research, Roswell

30308

Laureate Clinical Research Group, Atlanta

30338

Atlanta Pharmaceutical Research Center, Dunwoody

33136

University of Miami Diabetes Research Institute, Miami

33156

International Research Associates LLC, Miami

36608

Coastal Clinical Research Inc, Mobile

38119

Memphis Internal Medicine PLLC, Memphis

The Endocrine Clinic, Memphis

38133

AM Diabetes and Endocrinology Center, Bartlett

41013

Complejo Hospitalario Virgen del Rocio, Seville

41014

Complejo Hospitalario Nuestra Senora de Valme, Seville

41071

Hospital Virgen Macarena (policlinico) 2ª planta Servicio de Endocrinologia y Nutricion, Seville

44112

Cleveland Clinic Health System, East Cleveland

44195

Cleveland Clinic Foundation, Cleveland

45429

Wells Institute for Health Awareness, Kettering

45439

Providence Health Partners - Center of Clinical Research, Dayton

45459

Valley Medical Primary Care, Centerville

48081

KMED Research, Saint Clair Shores

48152

Michigan Institute of Medicine, Livonia

48201

Wayne State University, Detroit

55416

International Diabetes Center, Minneapolis

55435

Radiant Research Inc (Minneapolis), Edina

55455

Center for Urologic Clinical Trials University of Minnesota, Minneapolis

59101

Billings Clinic Research Division, Billings

59102

Montana Health Research Institute, Billings

60076

Clintell Inc, Skokie

60077

Clintell Inc (Ellyin), Skokie

60612

John H Stoger Jr Hospital of Cook County, Chicago

63117

MedEx Healthcare Research Inc, St Louis

63376

Amin Radparvar's Private Practice, City of Saint Peters

64000

Hospital OCA, Monterrey, Nuevo Leon

64460

Hospital Universitario Dr Jose E Gonzalez, Monterrey

66260

Hospital Santa Engracia-CIMA, Garza García

68131

Creighton Diabetes Center, Omaha

70002

Medical Research of Louisiana, Metairie

75230

Dallas Diabetes & Endocrine Center, Dallas

75231

North Texas Endocrine Center, Dallas

Radiant Research Dallas-North, Dallas

75246

Baylor Endocrine Center, Dallas

75251

Galenos Research, Dallas

76014

Israel Hartman MD, Arlington

76017

South Arlington Primary Care Assoc PA, Arlington

77074

Clinical Trial Network, Houston

77546

Spuhler Medical Associates, Friendswood

78205

Quality Assurance Research Center Inc, San Antonio

78229

Covenant Clinic Research, San Antonio

Diabetes & Glandular Disease Research Assoc PA, San Antonio

SAM Clinical Research Center, San Antonio

84107

Salt Lake Research, Salt Lake City

85712

Quality of Life Medical & Research Center, Tucson

85723

Southern Arizona VA Healthcare System, Tucson

85741

Tucson Clinical Research, Tucson

87106

New Mexico Clinical Research & Osteoporosis Center, Albuquerque

87131

University of New Mexico HCS, Albuquerque

90301

South Bay Clinical Research, Inglewood

90404

Coastal Biomedical Research Inc, Santa Monica

91105

Southern California Endocrine Center, Pasadena

91911

International Clinical Research Network, Chula Vista

92648

Diabetes/Lipid Management and Research Center, Huntington Beach

92780

Diabetes Research Center, Tustin

93710

Saad Hijazi MD Inc, Fresno

93720

Valley Research, Fresno

97210

Portland Diabetes & Endocrinology Center, Portland

97219

New Hope Research of Oregon, Portland

97239

Covance CRU Inc., Portland

97401

Oregon Medical Group Clinical Resesarch, Eugene

97404

Lane Medical Research Group, Eugene

98003

Larry D Stonesifer MD Inc PS, Federal Way

98055

Rainier Clinical Research Center Inc, Renton

98405

Cedar Research, Tacoma

Liberty Research Center, Tacoma

105229

NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense, Moscow

111399

NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70, Moscow

115280

Moscow City Clinical Hospital # 13, Moscow

119435

SEI HPE Moscow Medical Academy IM Sechenov of Roszdrav Clinic of Endocrinology, Moscow

125299

SI Internal Affairs of Moscow- Clinical Hospital, Moscow

125315

RAAMS Endocrinology and Diabetology Department, Moscow

150003

MHI Clinical Hospital for Emergency Care na NV Soloviev, Yaroslavl

150023

MCHI Medical Sanitary Unit of Novo-Yaroslavsky Oil Refining Plant, Yaroslavl

150062

NHI Yaroslavl Regional Clinical Hospital, Yaroslavl

193012

St Petersburg NHI City Polytclinic #77 City Diabetological Center #4, Saint Petersburg

194291

Central Medical Sanitary Unit #122, Saint Petersburg

197022

Pavlov State Medical Univ of St Petersburg, Saint Petersburg

214018

NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital, Smolensk

650061

NHI Kemerovo Regional Clinical Hospital, Kemerovo

B1870ARG

Hospital Interzonal de Agudos Pedro Fiorito, Avellaneda

B1824KAJ

FUNDAPRES/CIMel, Buenos Aires

C1117ABH

Centro Endocrinologic Tiempo, Buenos Aires

C1181ACH

Hospital Italiano de Buenos Aires, Buenos Aires

C1425AGC

Cons Asoc de Endocrinologia, Buenos Aires

C1426ABP

Centro Medico Dra De Salvo, Buenos Aires

90035-903

Hospital de Clinicas de Porto Alegre, Porto Alegre

90610-000

Hospital Sao Lucas da PUCRS, Porto Alegre

01244-030

CPClin-Centro de Pesquisas Clinicas, São Paulo

87020-900

Universidade Estabual de Maringa, Maringa Parana

08780-090

Nucleo de Medicina Integrada, Mogi das Cruzes

20211-340

Instituto Estadual De Diabetes e Endocrinologia Luis Capriglione, Rio de Janeiro

22271-100

Ccbr Brasil Centro de Analises e Pesquisas Clinicas Ltda, Rio de Janeiro

11045-904

Hospital Guilherme Alvaro, Santos

04025-011

Hospital do Rim e Hipertensao, São Paulo

04062-003

Instituto da Saude e Bem Estar da Mulher, São Paulo

05302-001

Blumenau Servicos Medicos S/C Ltda, São Paulo

05437-010

Centro de Pesquisa Clinica e Medicina Avancada, São Paulo

M3M 3E5

Keele Medical Place, Downsview

L6B 1A1

Quest Clinical Trials, Markham

L6H 3P1

Lifestyle Metabolism Center, Oakville

N7T 4X3

Sarnia Institute of Clinical Research, Sarnia

L4J 8L7

Lifestyle Metabolism Center, Thornhill

M4R 2G4

Lifestyle Metabolism Center, Toronto

Unknown

Hospital del Salvador, Santiago

Hospital Padre Alberto Hurtado, Santiago

Hospital Clinico Pontificia Universidad Catolica de Chile, Santiago

Hospital San Borja ArriaranUniversidad de Chile, Santiago

06700

Instituto Mexicano de Investigacion, Mexico City

01120

Centro de Estudios en Diabetes, Mexico City

CP14050

Cifbiotec, Mexico City

15-950

Oddzial Chorob Wewnetrznych, Bialystock

15-435

NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny, Bialystok

31 501

Katedra I Klinika Chorob Metabolicznych Collegium Medicum Uniwersytety Jagiellonskiego, Krakow

90 153

Klliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi, Lodz

93-338

Instytut Centrum Zdrowia (009) Matki Polki, Lodz

05 800

Szpital Kolejowy im Dr w Roeflera(009) Oddzial Gastorenterologii, Pruszków

01-911

NZOZ Diabetologiczna Poradnia Specjalistyczna, Warsaw

117 593

NI Central Clinical Hospital of RAS, Moscow

119 048

City Clinical Hospital # 61, Moscow

08304

Hospital de Mataro, Mataró

08003

Hospital del Mar (Cano), Barcelona

08022

Centro Médico Teknon, Barcelona

08208

Corporacion Sanitaria Parc Tauli Unidad de Endocrinologia, Sabadell

SG6 4UB

Birchwood Surgery, Letchworth Garden City

SG1 4AB

Lister Hospital, Stevenage

SE1 9RT

Guy's & St Thomas Hospital, London

PE7 3JL

Yaxley Group Practice, Peterborough

Sponsors
All Listed Sponsors
lead

Mannkind Corporation

INDUSTRY