Clinical trial NCT00332488: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Mannkind Corporation
Sponsor class: INDUSTRY
First posted: 2006-06-01
Enrollment: 547
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility 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 or 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)

Primary outcomes:
measure: Difference in Change From Baseline for HbA1c Between TI+ Metformin and Metformin+Secretagogue
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Difference in Change From Baseline for HbA1c Between TI Alone and Metformin+Secretagogue
timeFrame: Baseline to Week 12
measure: Change in HbA1c From Baseline to Week 24 (Subjects Who Stayed on Original Treatment)
timeFrame: Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Radiant Research-Birmingham
state: Alabama
city: Birmingham
country: United States
facility: Parkway Medical Center
state: Alabama
city: Phoenix
country: United States
facility: Redpoint Research
state: Arizona
city: Phoenix
country: United States
facility: Arizona Center for Clinical Research
state: Arizona
city: Chula Vista
country: United States
facility: International Clinical Research Network
state: California
city: Denver
country: United States
facility: National Jewish Medical & Research Center
state: Colorado
city: Denver
country: United States
facility: Creekside Endocrine Associates
state: Colorado
city: Denver
country: United States
facility: Jennifer Hone MD
state: Colorado
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Hollywood
country: United States
facility: Center for Diabetes & Endocrine Care
state: Florida
city: Miami
country: United States
facility: International Research Associates LLC
state: Florida
city: Chicago
country: United States
facility: Cedar-Crosse Research Center
state: Illinois
city: Chicago
country: United States
facility: John H Stoger Jr Hospital of Cook County
state: Illinois
city: Skokie
country: United States
facility: Clintell Inc
state: Illinois
city: Towson
country: United States
facility: James A Dicke MDPA
state: Maryland
city: Haverhill
country: United States
facility: East Coast Clinical Research Inc
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Livonia
country: United States
facility: Michigan Institute of Medicine
state: Michigan
city: St Louis
country: United States
facility: Clayton Medical Research
state: Missouri
city: St Louis
country: United States
facility: Raidant Research-St Louis
state: Missouri
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Omaha
country: United States
facility: Creighton Diabetes Center
state: Nebraska
city: Albuquerque
country: United States
facility: Lovelace Scientific Resources (Albuquerque)
state: New Mexico
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: New Hyde Park
country: United States
facility: North Shore Diabetes and Endocrine Associates
state: New York
city: Charlotte
country: United States
facility: Metrolina Internal Medicine
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Clinical Research Inc
state: North Carolina
city: Charlotte
country: United States
facility: Sensenbrenner Primary Care
state: North Carolina
city: Durham
country: United States
facility: Duke Medical Center
state: North Carolina
city: Dayton
country: United States
facility: Dayton Clinical Research
state: Ohio
city: Dayton
country: United States
facility: Providence Health Partners - Center of Clinical Research
state: Ohio
city: Portland
country: United States
facility: Radiant Research
state: Oregon
city: Greenville
country: United States
facility: Upstate Pharmaceutical Research
state: South Carolina
city: Collierville
country: United States
facility: Collierville Medical Specialists
state: Tennessee
city: Memphis
country: United States
facility: Memphis Internal Medicine (Kathawala)
state: Tennessee
city: Memphis
country: United States
facility: GoodLife Medical Center PLLC
state: Tennessee
city: Dallas
country: United States
facility: Baylor Endocrine Center
state: Texas
city: San Antonio
country: United States
facility: Quality Assurance Research Center Inc
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas Inc
state: Texas
city: San Antonio
country: United States
facility: Covenant Clinic Research
state: Texas
city: San Antonio
country: United States
facility: Diabetes & Glandular Disease Research Assoc PA
state: Texas
city: San Antonio
country: United States
facility: SAM Clinical Research Center
state: Texas
city: Tacoma
country: United States
facility: Cedar Research
state: Washington
city: Avellaneda
country: Argentina
facility: Hospital Interzonal de Agudos Pedro Fiorito
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Centro Endocrinologic Tiempo
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Cons Asoc de Endocrinologia
city: Buenos Aires
country: Argentina
facility: CIMeL
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da PUCRS
state: Rio Grande do Sul
city: Rio de Janeiro
country: Brazil
facility: Ccbr Brasil Centro de Analises e Pesquisas Clinicas Ltda
city: Santos
country: Brazil
facility: Hospital Guilherme Alvaro
city: Sao Paulo
country: Brazil
facility: CPClin-Centro de Pesquisas Clinicas
city: Sao Paulo
country: Brazil
facility: UNIFRSP
city: Sao Paulo
country: Brazil
facility: Hospital do Rim e Hipertensao
city: Sao Paulo
country: Brazil
facility: Instituto de Pesquisa Clinica e Medicina Avancada
city: Markham
country: Canada
facility: Quest Clinical Trials
state: Ontario
city: Oakville
country: Canada
facility: Lifestyle Metabolism Center
state: Ontario
city: Thornhill
country: Canada
facility: Lifestyle Metabolism Center
state: Ontario
city: Toronto
country: Canada
facility: Lifestyle Metabolism Center
state: Ontario
city: Toronto
country: Canada
facility: Trial Management Group Inc (Henein
state: Ontario
city: Richmond Hill
country: Canada
facility: Unimedico Management
city: Santiago
country: Chile
facility: Hospital Padre Alberto Hurtado
state: Region Metropolitana
city: Santiago
country: Chile
facility: Hospital Clinico Pontificia Universidad Catolica de Chile
city: Santiago
country: Chile
facility: Hospital del Salvador
city: Santiago
country: Chile
facility: Instituto de Informacion de Tramiento y Educacion en Salud
city: Ostrava-Kuncice
country: Czech Republic
facility: Diabetologicka a interni ambulance
state: CZE
city: Prague 4
country: Czech Republic
facility: Institute for Clinical and Exp Medicine
state: CZE
city: Prague 8
country: Czech Republic
facility: University Hospital Na Bulovce
state: CZE
city: Ostrava
country: Czech Republic
facility: Diabetologicka ambulance (Chmura)
city: Ostrava
country: Czech Republic
facility: Interní a diabetologická Outpatient
city: Praha 10
country: Czech Republic
facility: II interni klinika FN Kralovske Vinohrady
city: Praha 1
country: Czech Republic
facility: Endokrinologicky ustav
city: Praha 2
country: Czech Republic
facility: 3rd Medical Department General Faculty Hospital
city: Mexico City
country: Mexico
facility: Instituto Mexicano de Investigacion
state: Durango
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr Jose E Gonzalez
state: Nuevo Leon
city: Garza Garcia
country: Mexico
facility: Hospital Santa Engracia-CIMA
city: Mexico City
country: Mexico
facility: Centro de Estudios en Diabetes
city: Mexico City
country: Mexico
facility: Hospital General de Mexico Servicio EndocrinologiaJefe Del Servicio
city: Monterrey
country: Mexico
facility: OCA-MIRC
city: Bialystock
country: Poland
facility: Klinika Endocrinologii Diabetologii I
state: POL
city: Bialystok
country: Poland
facility: NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny
state: POL
city: Krakow
country: Poland
facility: Katedra I Klinika Chorob Metabolicznych Collegium Medicum Uniwersytety Jagiellonskiego
state: POL
city: Lodz
country: Poland
facility: Instytut Centrum Zdrowia (009) Matki Polki
state: POL
city: Pruszkow
country: Poland
facility: Spzital Kolejowy imm Wlodzimierza Roeflera
state: POL
city: Lodz
country: Poland
facility: Oddzial Kliniczny Diabetologii (009) Kliniczny nr 1 im Norberta Barlickiego Uniwersytety Meycznego
city: Warsaw
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED
city: Warszawa
country: Poland
facility: Centrum Leczenia Chorob cywilizacyjnych
city: Kemerovo
country: Russian Federation
facility: NHI Kemerovo Regional Clinical Hospital
state: RUS
city: Moscow
country: Russian Federation
facility: NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense
state: RUS
city: Moscow
country: Russian Federation
facility: NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70
state: RUS
city: Moscow
country: Russian Federation
facility: NI Endrocrinological Research Centre of RAMS In patient replacing technologies department
state: RUS
city: Moscow
country: Russian Federation
facility: NI Moscow Regional Scientific Research Clinical Institute na MF Vladimirsky
state: RUS
city: Smolensk
country: Russian Federation
facility: NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital
state: RUS
city: St Petersburg
country: Russian Federation
facility: St Petersburg NHI City Polytclinic #77 City Diabetological Center #4
state: RUS
city: St Petersburg
country: Russian Federation
facility: Central Medical Sanitary Unit #122
state: RUS
city: St Petersburg
country: Russian Federation
facility: TUV Medico-Military Academy
state: RUS
city: St. Petersburg
country: Russian Federation
facility: St Petersburg NHI Municipal Multi-Speciality Hospital # 2
state: RUS
city: Yaroslavl
country: Russian Federation
facility: MHI Clinical Hospital for Emergency Care na NV Soloviev
state: RUS
city: Yaroslavl
country: Russian Federation
facility: NHI Yaroslavl Regional Clinical Hospital
state: RUS
city: Moscow
country: Russian Federation
facility: NI Central Clinical Hospital of RAS
city: Sevilla
country: Spain
facility: Complejo Hospitalario Nuestra Senora de Valme
state: Andalucia
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial
city: Madrid
country: Spain
facility: Hospital Universitario de la Princessa
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Sabadell
country: Spain
facility: Corporacion Sanitaria Parc Tauli Unidad de Endocrinologia
city: Chernivtsy
country: Ukraine
facility: Bukovinian State Medical University Dept of Clinical Immun
state: UKR
city: Dniepropetrovsk
country: Ukraine
facility: Dniepropetrovsh State Medical Academy
state: UKR
city: Donetsk
country: Ukraine
facility: Donetsk State Medical University
state: UKR
city: Donetsk
country: Ukraine
facility: Donetsk State Medical University (Chair of Immun Allergogoly & Endocrin)
state: UKR
city: Donetsk
country: Ukraine
facility: Railway Clinical Hospital on Donetsk Station
state: UKR
city: Kiev
country: Ukraine
facility: Chair Family Med of National Med University
state: UKR
city: Kiev
country: Ukraine
facility: Institute of Endocrinology and Metabolism
state: UKR
city: Kiev
country: Ukraine
facility: Ukr Scientifically Practical Centre of Endocrine Surgery
state: UKR
city: Odessa
country: Ukraine
facility: Odessa State Medical University Dept of Gen Practice and Med Rehab
state: UKR
city: Odessa
country: Ukraine
facility: Odessa Reg. Clinical Hosp Outpatient Department
state: UKR
city: Odessa
country: Ukraine
facility: Odessa State Med Dept of Family Med and Gen Practice
state: UKR
city: Vinnitsa
country: Ukraine
facility: Vinnitsa State Medical University
state: UKR
city: Kiev
country: Ukraine
facility: Outpatient Clinic of Family Physician "Rusanovka"
city: Odessa
country: Ukraine
facility: Public Institution City Policlinic #20 Odessa
Study officials:
affiliation: Mannkind Corporation
name: For MannKind sponsored trials, the Overall Study Official is the Chief Scientific Officer
role: STUDY_DIRECTOR
References: