Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents in Subjects With Type 2 Diabetes

PHASE3CompletedINTERVENTIONAL
Enrollment

547

Participants

Timeline

Start Date

December 31, 2004

Primary Completion Date

March 31, 2008

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

Technosphere Insulin

Inhalation, 15U/30U, prandial

DRUG

Metformin & Secretagogues

Metformin tablets,Secretagogues supplied as any of the currently marketed brands and formulations.

DRUG

Technosphere Insulin & Metformin

Technosphere Insulin Inhalation Powder 15U/30U, Metformin tablets

Trial Locations (120)

2175

Ukr Scientifically Practical Centre of Endocrine Surgery, Kiev

10034

II interni klinika FN Kralovske Vinohrady, Prague

11042

North Shore Diabetes and Endocrine Associates, New Hyde Park

11501

Winthrop University Hospital, Mineola

11694

Endokrinologicky ustav, Prague

12801

3rd Medical Department General Faculty Hospital, Prague

21010

Vinnitsa State Medical University, Vinnitsa

21204

James A Dicke MDPA, Towson

27710

Duke Medical Center, Durham

28006

Hospital Universitario de la Princessa, Madrid

28034

Hospital Ramon y Cajal, Madrid

28204

Metrolina Internal Medicine, Charlotte

28211

Charlotte Clinical Research Inc, Charlotte

28277

Sensenbrenner Primary Care, Charlotte

29615

Upstate Pharmaceutical Research, Greenville

33021

Center for Diabetes & Endocrine Care, Hollywood

33156

International Research Associates LLC, Miami

35209

Radiant Research-Birmingham, Birmingham

35215

Parkway Medical Center, Birmingham

38017

Collierville Medical Specialists, Collierville

38119

Memphis Internal Medicine (Kathawala), Memphis

38120

GoodLife Medical Center PLLC, Memphis

41014

Complejo Hospitalario Nuestra Senora de Valme, Seville

45406

Dayton Clinical Research, Dayton

45439

Providence Health Partners - Center of Clinical Research, Dayton

48152

Michigan Institute of Medicine, Livonia

48201

Wayne State University, Detroit

49023

Dniepropetrovsh State Medical Academy, Dniepropetrovsk

58022

Bukovinian State Medical University Dept of Clinical Immun, Chernivtsy

60076

Clintell Inc, Skokie

60607

Cedar-Crosse Research Center, Chicago

60612

John H Stoger Jr Hospital of Cook County, Chicago

63110

Washington University School of Medicine, St Louis

63117

Clayton Medical Research, St Louis

63141

Raidant Research-St Louis, St Louis

64020

OCA-MIRC, Monterrey

64460

Hospital Universitario Dr Jose E Gonzalez, Monterrey

65009

Odessa State Medical University Dept of Gen Practice and Med Rehab, Odesa

65025

Odessa Reg. Clinical Hosp Outpatient Department, Odesa

65039

Odessa State Med Dept of Family Med and Gen Practice, Odesa

65114

Public Institution City Policlinic #20 Odessa, Odesa

66260

Hospital Santa Engracia-CIMA, Garza García

68131

Creighton Diabetes Center, Omaha

70200

Diabetologicka ambulance (Chmura), Ostrava

70702

Diabetologicka a interni ambulance, Ostrava-Kunčice

70900

Interní a diabetologická Outpatient, Ostrava

75246

Baylor Endocrine Center, Dallas

78205

Quality Assurance Research Center Inc, San Antonio

78229

Clinical Trials of Texas Inc, San Antonio

Covenant Clinic Research, San Antonio

Diabetes & Glandular Disease Research Assoc PA, San Antonio

SAM Clinical Research Center, San Antonio

80206

National Jewish Medical & Research Center, Denver

80209

Creekside Endocrine Associates, Denver

80220

Jennifer Hone MD, Denver

83003

Donetsk State Medical University, Donetsk

83099

Donetsk State Medical University (Chair of Immun Allergogoly & Endocrin), Donetsk

83114

Railway Clinical Hospital on Donetsk Station, Donetsk

85029

Redpoint Research, Phoenix

85032

Arizona Center for Clinical Research, Phoenix

87108

Lovelace Scientific Resources (Albuquerque), Albuquerque

91911

International Clinical Research Network, Chula Vista

97239

Radiant Research, Portland

98405

Cedar Research, 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

115478

NI Endrocrinological Research Centre of RAMS In patient replacing technologies department, Moscow

129110

NI Moscow Regional Scientific Research Clinical Institute na MF Vladimirsky, Moscow

150003

MHI Clinical Hospital for Emergency Care na NV Soloviev, 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

194354

St Petersburg NHI Municipal Multi-Speciality Hospital # 2, Saint Petersburg

198013

TUV Medico-Military Academy, Saint Petersburg

214018

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

650061

NHI Kemerovo Regional Clinical Hospital, Kemerovo

06708

Chase Medical Research, LLC, Waterbury

01830

East Coast Clinical Research Inc, Haverhill

B1870ARG

Hospital Interzonal de Agudos Pedro Fiorito, Avellaneda

C1117ABH

Centro Endocrinologic Tiempo, Buenos Aires

C1181ACH

Hospital Italiano de Buenos Aires, Buenos Aires

C1425AGC

Cons Asoc de Endocrinologia, Buenos Aires

Unknown

CIMeL, Buenos Aires

Hospital Padre Alberto Hurtado, Santiago

Hospital Clinico Pontificia Universidad Catolica de Chile, Santiago

Hospital del Salvador, Santiago

Instituto de Informacion de Tramiento y Educacion en Salud, Santiago

90035-903

Hospital de Clinicas de Porto Alegre, Porto Alegre

90610-000

Hospital Sao Lucas da PUCRS, Porto Alegre

22271-100

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

11045-904

Hospital Guilherme Alvaro, Santos

01244-030

CPClin-Centro de Pesquisas Clinicas, São Paulo

04020-050

UNIFRSP, São Paulo

04025-011

Hospital do Rim e Hipertensao, São Paulo

05437-010

Instituto de Pesquisa Clinica e Medicina Avancada, São Paulo

L6B 1A1

Quest Clinical Trials, Markham

L6H 3P1

Lifestyle Metabolism Center, Oakville

L4J 8L7

Lifestyle Metabolism Center, Thornhill

M4R 2G4

Lifestyle Metabolism Center, Toronto

M4T 1N5

Trial Management Group Inc (Henein, Toronto

L4C 9M7

Unimedico Management, Richmond Hill

140 21

Institute for Clinical and Exp Medicine, Prague

180 81

University Hospital Na Bulovce, Prague

06700

Instituto Mexicano de Investigacion, Mexico City

01120

Centro de Estudios en Diabetes, Mexico City

06726

Hospital General de Mexico Servicio EndocrinologiaJefe Del Servicio, Mexico City

15-276

Klinika Endocrinologii Diabetologii I, Bialystock

15-435

NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny, Bialystok

31 501

Katedra I Klinika Chorob Metabolicznych Collegium Medicum Uniwersytety Jagiellonskiego, Krakow

93-338

Instytut Centrum Zdrowia (009) Matki Polki, Lodz

05-800

Spzital Kolejowy imm Wlodzimierza Roeflera, Pruszków

90-153

Oddzial Kliniczny Diabetologii (009) Kliniczny nr 1 im Norberta Barlickiego Uniwersytety Meycznego, Lodz

02 777

Centrum Leczenia Chorob cywilizacyjnych, Warsaw

03 580

Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED, Warsaw

117 593

NI Central Clinical Hospital of RAS, Moscow

08036

Hospital Clinic I Provincial, Barcelona

08208

Corporacion Sanitaria Parc Tauli Unidad de Endocrinologia, Sabadell

04050

Chair Family Med of National Med University, Kiev

04114

Institute of Endocrinology and Metabolism, Kiev

02147

"Outpatient Clinic of Family Physician Rusanovka", Kiev

Sponsors
All Listed Sponsors
lead

Mannkind Corporation

INDUSTRY