Clinical trial NCT00332826: Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma
Official title: A Phase 3, 12-month Treatment, Multicenter, Randomized, Open-Label, Parallel Group Clinical Trial Comparing Prandial Subcutaneous Insulin With Prandial Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Asthma
Keywords: Inhaled insulin
Diabetes Type I and II with Asthma
Lead sponsor: Mannkind Corporation
Sponsor class: INDUSTRY
First posted: 2006-06-02
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The clinical trial is designed to evaluate the safety of inhaled Technosphere/Insulin compared with non-inhaled anti-diabetic therapies in subjects with type 1 or type 2 diabetes mellitus and concurrent asthma.


Eligibility criteria: Inclusion Criteria:

* A clinical diagnosis of Step 1 to 3 asthma as per the NAEPP guidelines
* Clinical diagnosis of Type 1 or Type 2 diabetes mellitus for at least 1 year
* Current stable anti-diabetic regimen (insulin alone or in combination with oral anti-hyperglycemic agents)
* Subjects must exhibit \<30% variability in PEF measurements during the 2 week run in period.
* Subjects must not meet any criteria for exacerbations of asthma during the 2 week run in period
* Body mass index (BMI) \< 40kg/m2
* HbA1c \>6.0% to \<11.5%

Exclusion Criteria:

* Severe complications of diabetes in the opinion of the investigator
* Seizure disorder
* Significant cardiovascular dysfunction and/or history within 3 months of screening
* Hypertension with systolic blood pressure of !80 mm Hg and/or diastolic blood pressure \>110 mm HG at screening despite pharmacologic therapy.
* Clinical nephrotic syndrome or renal dysfunction or disease
* Total daily insulin requirement of \>1.4 U/kg body weight
* Clinical diagnosis of Step 4 asthma
* Use of \>6 puffs/day of fast acting bronchodilator
* Currently using an insulin delivery pump
* Use of Pramlintide acetate or any incretins must be discontinued 8 weeks prior to screening
* Two or more severe hypoglycemic episodes within the past 6 months.
* Any hospitalization or emergency room visit due to poor diabetic control with 6 months of screening.
* Current use of systemic steroids
* Subjects who currently smoke tobacco or who have smoked within the past 6 months
* Urine cotinine test of \> 100ng/ml
* Current drug or alcohol abuse
* Clinically significant abnormalities on screening laboratory evaluation
* Cancer within the past 5 years or any history of lung neoplasms
* History of active and/or cirrhotic hepatic disease and/or abnormal liver enzymes.
* Active infection or history of severe infection with 30 days of screening.
* Anemia
* History of anaphylaxis and/or angioneurotic edema
* Diagnosis of chronic obstructive pulmonary disease (COPE)
* Previous exposure to any inhaled insulin product

Primary outcomes:
measure: The primary safety outcome will be measurements of post bronchodilator FEV1 throughout the treatment period
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Phoenix
country: United States
facility: Northwest Medical Center
state: Arizona
city: Tempe
country: United States
facility: Premiere Pharmaceutical Research LLC
state: Arizona
city: Tucson
country: United States
facility: Canyon Internal Medicine
state: Arizona
city: Buena Park
country: United States
facility: Associated Pharmaceutical Research Center Inc
state: California
city: Foothill Ranch
country: United States
facility: Family Medical Center
state: California
city: Long Beach
country: United States
facility: Health Care Partners Medical Group
state: California
city: Long Beach
country: United States
facility: Golden Pine Clinical Research
state: California
city: Los Angeles
country: United States
facility: Keck USC School of Medicine
state: California
city: Atlanta
country: United States
facility: Pinaccle Trials Inc (SMO)
state: Georgia
city: Atlanta
country: United States
facility: Executive Health and Research Associates Inc
state: Georgia
city: Dunwoody
country: United States
facility: Atlanta Pharmaceutical Research Center
state: Georgia
city: Roswell
country: United States
facility: Southeastern Endocrine & Diabetes
state: Georgia
city: Chicago
country: United States
facility: Cedar-Crosse Research Center
state: Illinois
city: Baltimore
country: United States
facility: Franklin Square Hospital
state: Maryland
city: Florissant
country: United States
facility: Healthcare Research
state: Missouri
city: St Louis
country: United States
facility: MedEx Healthcare Research Inc(009)
state: Missouri
city: Billings
country: United States
facility: Billings Clinic Research Division
state: Montana
city: Hillsborough
country: United States
facility: Your Doctors Care
state: New Jersey
city: Trenton
country: United States
facility: Hopewell Valley Family Medicine PA
state: New Jersey
city: New York
country: United States
facility: Eastside Comprehensive Medical Center
state: New York
city: Concord
country: United States
facility: Carolinas Research
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Dept of Endocrinology
state: Ohio
city: San Antonio
country: United States
facility: Diabetes & Glandular Disease Research Assoc PA
state: Texas
city: Waco
country: United States
facility: McLennan County Medical Education and Research Foundation
state: Texas
city: Buenos Aires
country: Argentina
facility: DIM (Clinica Privada)
city: La Plata
country: Argentina
facility: Ins De Inv Cardiovascular La Plata
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas - PUCRS (Fritscher)
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao
city: Rio de Janeiro
country: Brazil
facility: Ccbr Brasil Centro de Analises e Pesquisas Clinicas Ltda
city: Sao Paulo
country: Brazil
facility: CPClin-Centro de Pesquisas Clinicas
city: Sao Paulo
country: Brazil
facility: Clinica de Endocrinologia
city: Brampton
country: Canada
facility: Finchlea Medical Group
state: Ontario
city: Courtice
country: Canada
facility: Courtice Health Centre
state: Ontario
city: London
country: Canada
facility: Parkwood Hospital
state: Ontario
city: Sarnia
country: Canada
facility: The London Road Diagnostic Clinic and Medical Centre
state: Ontario
city: Toronto
country: Canada
facility: Albany Medical Center
state: Ontario
city: Windsor
country: Canada
facility: Windsor Professional Research
state: Ontario
city: Melnik
country: Czech Republic
facility: Surgery of Diabetology
state: CZE
city: Praha 5
country: Czech Republic
facility: Interni oddeleni nemocnice Na Homolce
state: CZE
city: Slany
country: Czech Republic
facility: Diabetologicka Outpatient Surgery of Diabetology
state: CZE
city: Ostrava
country: Czech Republic
facility: InternÃ- a diabetologickÃ¡ Outpatient
city: Ostrava
country: Czech Republic
facility: I InternÃ- klinika
city: Mexico City
country: Mexico
facility: Hospital Angeles Mocel
state: DF
city: Mexico City
country: Mexico
facility: Mexican Institute of Clinical Research
state: MX
city: Delegacion Cuauhtemoc
country: Mexico
facility: Nuevo Sanatorio Durango
city: Huixquilucan
country: Mexico
facility: Hospital Angeles de las Lomas
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: Dzial Badan Klinicznych Malopoiskie
state: POL
city: Krakow
country: Poland
facility: III Oddzial Chorob Wewnetrznych Szpital
state: POL
city: Lodz
country: Poland
facility: Oddzial Chorob Wewnetrznych Wojewodzki
state: Zgierz
city: Lodz
country: Poland
facility: Oddzial Kliniczny Diabetologii (009) Kliniczny nr 1 im Norberta Barlickiego Uniwersytety Meycznego
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
state: RUS
city: Moscow
country: Russian Federation
facility: Moscow State Medico-Stomatological University City Hospital # 23
state: RUS
city: Smolensk
country: Russian Federation
facility: Smolensk Medical Academy Smolensk Regional Clinical Hospital
state: RUS
city: St Petersburg
country: Russian Federation
facility: Central Medical Sanitary Unit #122
state: RUS
city: St. Petersburg
country: Russian Federation
facility: City Hospital # 2 Endocrinology Department
state: RUS
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Municipal Health Care Institution Clinical Hospital for Emergency Care na NV Soloviev
state: RUS
city: Moscow
country: Russian Federation
facility: Federal State Institution Pulmonology Research Institute of Federal Agency of HC&SD
city: Moscow
country: Russian Federation
facility: City Clinical Hospital #64 Center of Applied Clinical Paharmacology Friendship University
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital of Russian Science Academy
city: Moscow
country: Russian Federation
facility: City Clinical Hospital # 61
city: Moscow
country: Russian Federation
facility: Russian Scientific Center of Restoration Medicine & Balneology
city: St Petersburg
country: Russian Federation
facility: St Petersburg Medical Academy (Ilkovich)
city: Barcelona
country: Spain
facility: Hospital 2 de Maig
city: Donetsk
country: Ukraine
facility: Donetsk State Medical University
state: UKR
city: Donetsk
country: Ukraine
facility: Donetsk State Medical University
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: London
country: United Kingdom
facility: Clinical Research Centre The Royal London Hospital
state: GBR
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
state: GBR
city: West Midlands
country: United Kingdom
facility: Birmingham Heartland Hospital
state: GBR
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital Department of Medicine
Study officials:
References: