Study Stopped
Non-safety related business decision to combine special population protocols
Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma
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
1 other identifier
interventional
3
11 countries
78
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2006
Shorter than P25 for phase_3
78 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2006
CompletedStudy Start
First participant enrolled
June 1, 2006
CompletedFirst Posted
Study publicly available on registry
June 2, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedMay 4, 2012
May 1, 2012
1.3 years
June 1, 2006
May 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary safety outcome will be measurements of post bronchodilator FEV1 throughout the treatment period
Interventions
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (78)
Arizona Research Center
Phoenix, Arizona, 85023, United States
Northwest Medical Center
Phoenix, Arizona, 85029, United States
Premiere Pharmaceutical Research LLC
Tempe, Arizona, 85282, United States
Canyon Internal Medicine
Tucson, Arizona, 85712, United States
Associated Pharmaceutical Research Center Inc
Buena Park, California, 90620, United States
Family Medical Center
Foothill Ranch, California, 92610, United States
Health Care Partners Medical Group
Long Beach, California, 90806, United States
Golden Pine Clinical Research
Long Beach, California, 90807, United States
Keck USC School of Medicine
Los Angeles, California, 90033, United States
Pinaccle Trials Inc (SMO)
Atlanta, Georgia, 30329, United States
Executive Health and Research Associates Inc
Atlanta, Georgia, 30342, United States
Atlanta Pharmaceutical Research Center
Dunwoody, Georgia, 30338, United States
Southeastern Endocrine & Diabetes
Roswell, Georgia, 30076, United States
Cedar-Crosse Research Center
Chicago, Illinois, 60607, United States
Franklin Square Hospital
Baltimore, Maryland, 21237, United States
Healthcare Research
Florissant, Missouri, 63031, United States
MedEx Healthcare Research Inc(009)
St Louis, Missouri, 63117, United States
Billings Clinic Research Division
Billings, Montana, 59101, United States
Your Doctors Care
Hillsborough, New Jersey, 08844, United States
Hopewell Valley Family Medicine PA
Trenton, New Jersey, 08618, United States
Eastside Comprehensive Medical Center
New York, New York, 10021, United States
Carolinas Research
Concord, North Carolina, 28025, United States
Cleveland Clinic Dept of Endocrinology
Cleveland, Ohio, 44195, United States
Diabetes & Glandular Disease Research Assoc PA
San Antonio, Texas, 78229, United States
McLennan County Medical Education and Research Foundation
Waco, Texas, 76707, United States
DIM (Clinica Privada)
Buenos Aires, 1704, Argentina
Ins De Inv Cardiovascular La Plata
La Plata, Argentina
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90035-070, Brazil
Hospital Sao Lucas - PUCRS (Fritscher)
Porto Alegre, 90610-000, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre, 91350-200, Brazil
Ccbr Brasil Centro de Analises e Pesquisas Clinicas Ltda
Rio de Janeiro, 22271-100, Brazil
CPClin-Centro de Pesquisas Clinicas
São Paulo, 01244-030, Brazil
Clinica de Endocrinologia
São Paulo, 01323-001, Brazil
Finchlea Medical Group
Brampton, Ontario, L6T 3J1, Canada
Courtice Health Centre
Courtice, Ontario, L1E 3C3, Canada
Parkwood Hospital
London, Ontario, N6C 5J1, Canada
The London Road Diagnostic Clinic and Medical Centre
Sarnia, Ontario, N7T 4X3, Canada
Albany Medical Center
Toronto, Ontario, M4K 1N5, Canada
Windsor Professional Research
Windsor, Ontario, N8X 3V6, Canada
Surgery of Diabetology
Mělník, CZE, 276 01, Czechia
Interni oddeleni nemocnice Na Homolce
Prague, CZE, 15031, Czechia
Diabetologicka Outpatient Surgery of Diabetology
Slaný, CZE, 274 01, Czechia
InternÃ- a diabetologická Outpatient
Ostrava, Ostrava, 70900, Czechia
I InternÃ- klinika
Ostrava, Ostrava, 728 80, Czechia
Hospital Angeles Mocel
Mexico City, Mexico City, 06726, Mexico
Mexican Institute of Clinical Research
Mexico City, MX, 06700, Mexico
Nuevo Sanatorio Durango
Delegacion Cuauhtemoc, 6700, Mexico
Hospital Angeles de las Lomas
Huixquilucan, 52760, Mexico
Klinika Endocrinologii Diabetologii I
Bialystock, POL, 15-276, Poland
NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny
Bialystok, POL, 15-435, Poland
Dzial Badan Klinicznych Malopoiskie
Krakow, POL, 30 510, Poland
III Oddzial Chorob Wewnetrznych Szpital
Krakow, POL, 31121, Poland
Oddzial Chorob Wewnetrznych Wojewodzki
Lodz, Zgierz, 95-100, Poland
Oddzial Kliniczny Diabetologii (009) Kliniczny nr 1 im Norberta Barlickiego Uniwersytety Meycznego
Lodz, 90-153, Poland
NHI Kemerovo Regional Clinical Hospital
Kemerovo, RUS, 650061, Russia
NI Principal Military Clinical Hospital n a academician N.N. Burdenko
Moscow, RUS, 105229, Russia
Moscow State Medico-Stomatological University City Hospital # 23
Moscow, RUS, 109240, Russia
Central Medical Sanitary Unit #122
Saint Petersburg, RUS, 194291, Russia
City Hospital # 2 Endocrinology Department
Saint Petersburg, RUS, 194354, Russia
Smolensk Medical Academy Smolensk Regional Clinical Hospital
Smolensk, RUS, 214018, Russia
Yaroslavl Municipal Health Care Institution Clinical Hospital for Emergency Care na NV Soloviev
Yaroslavl, RUS, 150003, Russia
Federal State Institution Pulmonology Research Institute of Federal Agency of HC&SD
Moscow, 105077, Russia
City Clinical Hospital #64 Center of Applied Clinical Paharmacology Friendship University
Moscow, 117 198, Russia
Central Clinical Hospital of Russian Science Academy
Moscow, 117 593, Russia
City Clinical Hospital # 61
Moscow, 119 048, Russia
Russian Scientific Center of Restoration Medicine & Balneology
Moscow, 121069, Russia
St Petersburg Medical Academy (Ilkovich)
Saint Petersburg, Russia
Hospital 2 de Maig
Barcelona, Barcelona, 30108025, Spain
Donetsk State Medical University
Donetsk, UKR, 83003, Ukraine
Donetsk State Medical University
Donetsk, UKR, 83009, Ukraine
Railway Clinical Hospital on Donetsk Station
Donetsk, UKR, 83114, Ukraine
Chair Family Med of National Med University
Kiev, UKR, 04050, Ukraine
Institute of Endocrinology and Metabolism
Kiev, UKR, 04114, Ukraine
Clinical Research Centre The Royal London Hospital
London, GBR, E1 2AT, United Kingdom
Northern General Hospital
Sheffield, GBR, S5 7AU, United Kingdom
Birmingham Heartland Hospital
West Midlands, GBR, B9 5SS, United Kingdom
Addenbrooke's Hospital Department of Medicine
Cambridge, CB2 2QQ, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 1, 2006
First Posted
June 2, 2006
Study Start
June 1, 2006
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
May 4, 2012
Record last verified: 2012-05