Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma
- Conditions
- Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2Asthma
- Registration Number
- NCT00332826
- Lead Sponsor
- Mannkind Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
- 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%
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary safety outcome will be measurements of post bronchodilator FEV1 throughout the treatment period
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (77)
Finchlea Medical Group
๐จ๐ฆBrampton, Ontario, Canada
Executive Health and Research Associates Inc
๐บ๐ธAtlanta, Georgia, United States
Pinaccle Trials Inc (SMO)
๐บ๐ธAtlanta, Georgia, United States
Cleveland Clinic Dept of Endocrinology
๐บ๐ธCleveland, Ohio, United States
Albany Medical Center
๐จ๐ฆToronto, Ontario, Canada
Hospital de Clinicas de Porto Alegre
๐ง๐ทPorto Alegre, Rio Grande do Sul, Brazil
Family Medical Center
๐บ๐ธFoothill Ranch, California, United States
Southeastern Endocrine & Diabetes
๐บ๐ธRoswell, Georgia, United States
Eastside Comprehensive Medical Center
๐บ๐ธNew York, New York, United States
Health Care Partners Medical Group
๐บ๐ธLong Beach, California, United States
Associated Pharmaceutical Research Center Inc
๐บ๐ธBuena Park, California, United States
The London Road Diagnostic Clinic and Medical Centre
๐จ๐ฆSarnia, Ontario, Canada
Healthcare Research
๐บ๐ธFlorissant, Missouri, United States
MedEx Healthcare Research Inc(009)
๐บ๐ธSt Louis, Missouri, United States
Carolinas Research
๐บ๐ธConcord, North Carolina, United States
Keck USC School of Medicine
๐บ๐ธLos Angeles, California, United States
Franklin Square Hospital
๐บ๐ธBaltimore, Maryland, United States
Windsor Professional Research
๐จ๐ฆWindsor, Ontario, Canada
Golden Pine Clinical Research
๐บ๐ธLong Beach, California, United States
Cedar-Crosse Research Center
๐บ๐ธChicago, Illinois, United States
Birmingham Heartland Hospital
๐ฌ๐งWest Midlands, GBR, United Kingdom
Atlanta Pharmaceutical Research Center
๐บ๐ธDunwoody, Georgia, United States
Hospital Sao Lucas - PUCRS (Fritscher)
๐ง๐ทPorto Alegre, Brazil
Clinical Research Centre The Royal London Hospital
๐ฌ๐งLondon, GBR, United Kingdom
Institute of Endocrinology and Metabolism
๐บ๐ฆKiev, UKR, Ukraine
Hospital 2 de Maig
๐ช๐ธBarcelona, Spain
Addenbrooke's Hospital Department of Medicine
๐ฌ๐งCambridge, United Kingdom
CPClin-Centro de Pesquisas Clinicas
๐ง๐ทSao Paulo, Brazil
Billings Clinic Research Division
๐บ๐ธBillings, Montana, United States
Ins De Inv Cardiovascular La Plata
๐ฆ๐ทLa Plata, Argentina
Oddzial Chorob Wewnetrznych Wojewodzki
๐ต๐ฑLodz, Zgierz, Poland
Diabetes & Glandular Disease Research Assoc PA
๐บ๐ธSan Antonio, Texas, United States
McLennan County Medical Education and Research Foundation
๐บ๐ธWaco, Texas, United States
DIM (Clinica Privada)
๐ฆ๐ทBuenos Aires, Argentina
Irmandade da Santa Casa de Misericordia de Porto Alegre
๐ง๐ทPorto Alegre, Brazil
Ccbr Brasil Centro de Analises e Pesquisas Clinicas Ltda
๐ง๐ทRio de Janeiro, Brazil
Clinica de Endocrinologia
๐ง๐ทSao Paulo, Brazil
Parkwood Hospital
๐จ๐ฆLondon, Ontario, Canada
Courtice Health Centre
๐จ๐ฆCourtice, Ontario, Canada
Surgery of Diabetology
๐จ๐ฟMelnik, CZE, Czech Republic
Interni oddeleni nemocnice Na Homolce
๐จ๐ฟPraha 5, CZE, Czech Republic
Nuevo Sanatorio Durango
๐ฒ๐ฝDelegacion Cuauhtemoc, Mexico
Diabetologicka Outpatient Surgery of Diabetology
๐จ๐ฟSlany, CZE, Czech Republic
Hospital Angeles de las Lomas
๐ฒ๐ฝHuixquilucan, Mexico
Internร- a diabetologickรยก Outpatient
๐จ๐ฟOstrava, Czech Republic
Mexican Institute of Clinical Research
๐ฒ๐ฝMexico City, MX, Mexico
I Internร- klinika
๐จ๐ฟOstrava, Czech Republic
Hospital Angeles Mocel
๐ฒ๐ฝMexico City, DF, Mexico
III Oddzial Chorob Wewnetrznych Szpital
๐ต๐ฑKrakow, POL, Poland
Klinika Endocrinologii Diabetologii I
๐ต๐ฑBialystock, POL, Poland
NHI Kemerovo Regional Clinical Hospital
๐ท๐บKemerovo, RUS, Russian Federation
NI Principal Military Clinical Hospital n a academician N.N. Burdenko
๐ท๐บMoscow, RUS, Russian Federation
Smolensk Medical Academy Smolensk Regional Clinical Hospital
๐ท๐บSmolensk, RUS, Russian Federation
Central Medical Sanitary Unit #122
๐ท๐บSt Petersburg, RUS, Russian Federation
Federal State Institution Pulmonology Research Institute of Federal Agency of HC&SD
๐ท๐บMoscow, Russian Federation
City Hospital # 2 Endocrinology Department
๐ท๐บSt. Petersburg, RUS, Russian Federation
Central Clinical Hospital of Russian Science Academy
๐ท๐บMoscow, Russian Federation
Yaroslavl Municipal Health Care Institution Clinical Hospital for Emergency Care na NV Soloviev
๐ท๐บYaroslavl, RUS, Russian Federation
Russian Scientific Center of Restoration Medicine & Balneology
๐ท๐บMoscow, Russian Federation
City Clinical Hospital # 61
๐ท๐บMoscow, Russian Federation
St Petersburg Medical Academy (Ilkovich)
๐ท๐บSt Petersburg, Russian Federation
Donetsk State Medical University
๐บ๐ฆDonetsk, UKR, Ukraine
Northern General Hospital
๐ฌ๐งSheffield, GBR, United Kingdom
Hospital Nossa Senhora da Conceicao
๐ง๐ทPorto Alegre, Brazil
Your Doctors Care
๐บ๐ธHillsborough, New Jersey, United States
Oddzial Kliniczny Diabetologii (009) Kliniczny nr 1 im Norberta Barlickiego Uniwersytety Meycznego
๐ต๐ฑLodz, Poland
Moscow State Medico-Stomatological University City Hospital # 23
๐ท๐บMoscow, RUS, Russian Federation
Railway Clinical Hospital on Donetsk Station
๐บ๐ฆDonetsk, UKR, Ukraine
Chair Family Med of National Med University
๐บ๐ฆKiev, UKR, Ukraine
NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny
๐ต๐ฑBialystok, POL, Poland
Arizona Research Center
๐บ๐ธPhoenix, Arizona, United States
Northwest Medical Center
๐บ๐ธPhoenix, Arizona, United States
Hopewell Valley Family Medicine PA
๐บ๐ธTrenton, New Jersey, United States
Premiere Pharmaceutical Research LLC
๐บ๐ธTempe, Arizona, United States
Dzial Badan Klinicznych Malopoiskie
๐ต๐ฑKrakow, POL, Poland
Canyon Internal Medicine
๐บ๐ธTucson, Arizona, United States
City Clinical Hospital #64 Center of Applied Clinical Paharmacology Friendship University
๐ท๐บMoscow, Russian Federation