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

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: Technosphere Insulin (Drug); Metformin & Secretagogues (Drug); Technosphere Insulin & Metformin (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Mannkind Corporation

Official(s) and/or principal investigator(s):
Anders Boss, Study Director, Affiliation: Mannkind Corporation

to demonstrate the efficacy of inhaled Technosphere/Insulin in combination with metformin versus combination metformin and a secretagogue

Official title: A Phase 3, 24-Week, Multi-Center, Open-Label, Randomized, Controlled Trial Comparing the Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents (Metformin and a Secretagogue) in Subjects With Type 2 Diabetes Mellitus Sub-Optimally Controlled on Combination Metformin and a Secretagogue.

Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline to Week 12 in glycated hemoglobin

Secondary outcome: Change in HbA1c from baseline

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Non-smokers with clinical diagnosis of Type 2 diabetes mellitus for >or= to 6 months

- Stable regimen of metformin for > or = to 1000mg/day 9or maximum tolerated dose) and a

secretagogue < or = 1/2 the maximum manufacturer-recommended daily dose without any dose adjustments within the preceding 6 wks.

- Fixed dose combination products of metformin and sulfonylurea are acceptable as long

as each individual dose meets inclusion criteria

- HbA1c >or= to 7. 5% and < or= to 11. 0%

- BMI < or = to 40kg/m2.

- FEV1> or = to 70%, Total Lung capacity and > or =80% DLco > or= to 70%

Exclusion Criteria:

- Treatment with any type of anti-diabetic therapy, other than metformin & secretagogues

within the preceding 12 weeks

- Serum creatinine > 1. 4mg/dL in female subjects and >1. 5mg/dL in male subjects

- History of chronic obstructive pulmonary disease, clinically proven asthma and/or any

other clinically important pulmonary function testing and/or radiologic findings

- Evidence of serious complications of diabetes (e. g. autonomic neuropathy)

Centro Endocrinologic Tiempo, Buenos Aires C1117ABH, Argentina

CIMeL, Buenos Aires, Argentina

Hospital Italiano de Buenos Aires, Buenos Aires C1181ACH, Argentina

Cons Asoc de Endocrinologia, Buenos Aires C1425AGC, Argentina

Ccbr Brasil Centro de Analises e Pesquisas Clinicas Ltda, Rio de Janeiro 22271-100, Brazil

UNIFRSP, Sao Paulo 04020-050, Brazil

Instituto de Pesquisa Clinica e Medicina Avancada, Sao Paulo 05437-010, Brazil

CPClin-Centro de Pesquisas Clinicas, Sao Paulo 01244-030, Brazil

Hospital Guilherme Alvaro, Santos 11045-904, Brazil

Hospital do Rim e Hipertensao, Sao Paulo 04025-011, Brazil

Unimedico Management, Richmond Hill L4C 9M7, Canada

Hospital Clinico Pontificia Universidad Catolica de Chile, Santiago, Chile

Hospital del Salvador, Santiago, Chile

Instituto de Informacion de Tramiento y Educacion en Salud, Santiago, Chile

Diabetologicka ambulance (Chmura), Ostrava 70200, Czech Republic

Endokrinologicky ustav, Praha 1 11694, Czech Republic

3rd Medical Department General Faculty Hospital, Praha 2 12801, Czech Republic

II interni klinika FN Kralovske Vinohrady, Praha 10 10034, Czech Republic

Interní a diabetologická Outpatient, Ostrava 70900, Czech Republic

Hospital General de Mexico Servicio Endocrinologia Jefe Del Servicio, Mexico City 06726, Mexico

Centro de Estudios en Diabetes, Mexico City 01120, Mexico

OCA-MIRC, Monterrey 64020, Mexico

Hospital Santa Engracia-CIMA, Garza Garcia 66260, Mexico

Oddzial Kliniczny Diabetologii (009) Kliniczny nr 1 im Norberta Barlickiego Uniwersytety Meycznego, Lodz 90-153, Poland

Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED, Warsaw 03 580, Poland

Centrum Leczenia Chorob cywilizacyjnych, Warszawa 02 777, Poland

NI Central Clinical Hospital of RAS, Moscow 117 593, Russian Federation

Hospital Ramon y Cajal, Madrid 28034, Spain

Hospital Universitario de la Princessa, Madrid 28006, Spain

Corporacion Sanitaria Parc Tauli Unidad de Endocrinologia, Sabadell 08208, Spain

Hospital Clinic I Provincial, Barcelona 08036, Spain

Public Institution City Policlinic #20 Odessa, Odessa 65114, Ukraine

Outpatient Clinic of Family Physician "Rusanovka", Kiev 02147, Ukraine

Radiant Research-Birmingham, Birmingham, Alabama 35209, United States

Parkway Medical Center, Birmingham, Alabama 35215, United States

Complejo Hospitalario Nuestra Senora de Valme, Sevilla, Andalucia 41014, Spain

Redpoint Research, Phoenix, Arizona 85029, United States

Arizona Center for Clinical Research, Phoenix, Arizona 85032, United States

Hospital Interzonal de Agudos Pedro Fiorito, Avellaneda, Buenos Aires B1870ARG, Argentina

Institute for Clinical and Exp Medicine, Prague 4, CZE 140 21, Czech Republic

University Hospital Na Bulovce, Prague 8, CZE 180 81, Czech Republic

Diabetologicka a interni ambulance, 707 02 Ostrava-Kuncice, CZE 70702, Czech Republic

International Clinical Research Network, Chula Vista, California 91911, United States

Jennifer Hone MD, Denver, Colorado 80220, United States

Creekside Endocrine Associates, Denver, Colorado 80209, United States

National Jewish Medical & Research Center, Denver, Colorado 80206, United States

Chase Medical Research, LLC, Waterbury, Connecticut 06708, United States

Instituto Mexicano de Investigacion, Mexico City, Durango 06700, Mexico

Center for Diabetes & Endocrine Care, Hollywood, Florida 33021, United States

International Research Associates LLC, Miami, Florida 33156, United States

John H Stoger Jr Hospital of Cook County, Chicago, Illinois 60612, United States

Cedar-Crosse Research Center, Chicago, Illinois 60607, United States

Clintell Inc, Skokie, Illinois 60076, United States

James A Dicke MDPA, Towson, Maryland 21204, United States

East Coast Clinical Research Inc, Haverhill, Massachusetts 01830, United States

Wayne State University, Detroit, Michigan 48201, United States

Michigan Institute of Medicine, Livonia, Michigan 48152, United States

Raidant Research-St Louis, St Louis, Missouri 63141, United States

Clayton Medical Research, St Louis, Missouri 63117, United States

Washington University School of Medicine, St. Louis, Missouri 63110, United States

Creighton Diabetes Center, Omaha, Nebraska 68131, United States

Lovelace Scientific Resources (Albuquerque), Albuquerque, New Mexico 87108, United States

North Shore Diabetes and Endocrine Associates, New Hyde Park, New York 11042, United States

Winthrop University Hospital, Mineola, New York 11501, United States

Charlotte Clinical Research Inc, Charlotte, North Carolina 28211, United States

Sensenbrenner Primary Care, Charlotte, North Carolina 28277, United States

Metrolina Internal Medicine, Charlotte, North Carolina 28204, United States

Duke Medical Center, Durham, North Carolina 27710, United States

Hospital Universitario Dr Jose E Gonzalez, Monterrey, Nuevo Leon 64460, Mexico

Providence Health Partners - Center of Clinical Research, Dayton, Ohio 45439, United States

Dayton Clinical Research, Dayton, Ohio 45406, United States

Lifestyle Metabolism Center, Toronto, Ontario M4R 2G4, Canada

Lifestyle Metabolism Center, Thornhill, Ontario L4J 8L7, Canada

Lifestyle Metabolism Center, Oakville, Ontario L6H 3P1, Canada

Quest Clinical Trials, Markham, Ontario L6B 1A1, Canada

Trial Management Group Inc (Henein, Toronto, Ontario M4T 1N5, Canada

Radiant Research, Portland, Oregon 97239, United States

NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny, Bialystok, POL 15-435, Poland

Instytut Centrum Zdrowia (009) Matki Polki, Lodz, POL 93-338, Poland

Katedra I Klinika Chorob Metabolicznych Collegium Medicum Uniwersytety Jagiellonskiego, Krakow, POL 31 501, Poland

Spzital Kolejowy imm Wlodzimierza Roeflera, Pruszkow, POL 05-800, Poland

Klinika Endocrinologii Diabetologii I, Bialystock, POL 15-276, Poland

NHI Kemerovo Regional Clinical Hospital, Kemerovo, RUS 650061, Russian Federation

NI Moscow Regional Scientific Research Clinical Institute na MF Vladimirsky, Moscow, RUS 129110, Russian Federation

Central Medical Sanitary Unit #122, St Petersburg, RUS 194291, Russian Federation

NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense, Moscow, RUS 105229, Russian Federation

MHI Clinical Hospital for Emergency Care na NV Soloviev, Yaroslavl, RUS 150003, Russian Federation

St Petersburg NHI City Polytclinic #77 City Diabetological Center #4, St Petersburg, RUS 193012, Russian Federation

NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70, Moscow, RUS 111399, Russian Federation

TUV Medico-Military Academy, St Petersburg, RUS 198013, Russian Federation

St Petersburg NHI Municipal Multi-Speciality Hospital # 2, St. Petersburg, RUS 194354, Russian Federation

NHI Yaroslavl Regional Clinical Hospital, Yaroslavl, RUS 150062, Russian Federation

NI Endrocrinological Research Centre of RAMS In patient replacing technologies department, Moscow, RUS 115478, Russian Federation

NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital, Smolensk, RUS 214018, Russian Federation

Hospital Padre Alberto Hurtado, Santiago, Region Metropolitana, Chile

Hospital Sao Lucas da PUCRS, Porto Alegre, Rio Grande do Sul 90610-000, Brazil

Hospital de Clinicas de Porto Alegre, Porto Alegre, Rio Grande do Sul 90035-903, Brazil

Upstate Pharmaceutical Research, Greenville, South Carolina 29615, United States

GoodLife Medical Center PLLC, Memphis, Tennessee 38120, United States

Memphis Internal Medicine (Kathawala), Memphis, Tennessee 38119, United States

Collierville Medical Specialists, Collierville, Tennessee 38017, United States

Clinical Trials of Texas Inc, San Antonio, Texas 78229, United States

Covenant Clinic Research, San Antonio, Texas 78229, United States

Diabetes & Glandular Disease Research Assoc PA, San Antonio, Texas 78229, United States

Quality Assurance Research Center Inc, San Antonio, Texas 78205, United States

Baylor Endocrine Center, Dallas, Texas 75246, United States

SAM Clinical Research Center, San Antonio, Texas 78229, United States

Railway Clinical Hospital on Donetsk Station, Donetsk, UKR 83114, Ukraine

Ukr Scientifically Practical Centre of Endocrine Surgery, Kiev, UKR 2175, Ukraine

Donetsk State Medical University, Donetsk, UKR 83003, Ukraine

Institute of Endocrinology and Metabolism, Kiev, UKR 04114, Ukraine

Odessa Reg. Clinical Hosp Outpatient Department, Odessa, UKR 65025, Ukraine

Odessa State Med Dept of Family Med and Gen Practice, Odessa, UKR 65039, Ukraine

Donetsk State Medical University (Chair of Immun Allergogoly & Endocrin), Donetsk, UKR 83099, Ukraine

Bukovinian State Medical University Dept of Clinical Immun, Chernivtcy, UKR 58022, Ukraine

Dniepropetrovsh State Medical Academy, Dniepropetrovsk, UKR 49023, Ukraine

Vinnitsa State Medical University, Vinnitsa, UKR 21010, Ukraine

Chair Family Med of National Med University, Kiev, UKR 04050, Ukraine

Odessa State Medical University Dept of Gen Practice and Med Rehab, Odessa, UKR 65009, Ukraine

Cedar Research, Tacoma, Washington 98405, United States

Starting date: December 2004
Ending date: October 2008
Last updated: February 28, 2008