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Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma
This study has been terminated.
( Non-safety related business decision to combine special population protocols )
First Received: June 1, 2006   Last Updated: October 12, 2009   History of Changes
Sponsor: Mannkind Corporation
Information provided by: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT00332826
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Asthma
Drug: Technosphere Insulin
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment
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

Resource links provided by NLM:


Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:
  • The primary safety outcome will be measurements of post bronchodilator FEV1 throughout the treatment period

Estimated Enrollment: 193
Study Start Date: June 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00332826

  Hide Study Locations
Locations
United States, Arizona
Arizona Research Center
Phoenix, Arizona, United States, 85023
Northwest Medical Center
Phoenix, Arizona, United States, 85029
Premiere Pharmaceutical Research LLC
Tempe, Arizona, United States, 85282
Canyon Internal Medicine
Tucson, Arizona, United States, 85712
United States, California
Family Medical Center
Foothill Ranch, California, United States, 92610
Golden Pine Clinical Research
Long Beach, California, United States, 90807
Associated Pharmaceutical Research Center Inc
Buena Park, California, United States, 90620
Keck USC School of Medicine
Los Angeles, California, United States, 90033
Health Care Partners Medical Group
Long Beach, California, United States, 90806
United States, Georgia
Pinaccle Trials Inc (SMO)
Atlanta, Georgia, United States, 30329
Pinaccle Trials Inc (SMO)
Atlanta, Georgia, United States, 30329
Executive Health and Research Associates Inc
Atlanta, Georgia, United States, 30342
Atlanta Pharmaceutical Research Center
Dunwoody, Georgia, United States, 30338
Southeastern Endocrine & Diabetes
Roswell, Georgia, United States, 30076
United States, Illinois
Cedar-Crosse Research Center
Chicago, Illinois, United States, 60607
United States, Maryland
Franklin Square Hospital
Baltimore, Maryland, United States, 21237
United States, Missouri
MedEx Healthcare Research Inc(009)
St Louis, Missouri, United States, 63117
Healthcare Research
Florissant, Missouri, United States, 63031
United States, Montana
Billings Clinic Research Division
Billings, Montana, United States, 59101
United States, New Jersey
Hopewell Valley Family Medicine PA
Trenton, New Jersey, United States, 08618
Your Doctors Care
Hillsborough, New Jersey, United States, 08844
United States, New York
Eastside Comprehensive Medical Center
New York, New York, United States, 10021
United States, North Carolina
Carolinas Research
Concord, North Carolina, United States, 28025
United States, Ohio
Cleveland Clinic Dept of Endocrinology
Cleveland, Ohio, United States, 44195
United States, Texas
Diabetes & Glandular Disease Research Assoc PA
San Antonio, Texas, United States, 78229
McLennan County Medical Education and Research Foundation
Waco, Texas, United States, 76707
Argentina
Ins De Inv Cardiovascular La Plata
La Plata, Argentina
DIM (Clinica Privada)
Buenos Aires, Argentina, 1704
Brazil
Ccbr Brasil Centro de Analises e Pesquisas Clinicas Ltda
Rio de Janeiro, Brazil, 22271-100
CPClin-Centro de Pesquisas Clinicas
Sao Paulo, Brazil, 01244-030
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Brazil, 90035-070
Hospital Nossa Senhora da Conceicao
Porto Alegre, Brazil, 91350-200
Hospital Sao Lucas - PUCRS (Fritscher)
Porto Alegre, Brazil, 90610-000
Clinica de Endocrinologia
Sao Paulo, Brazil, 01323-001
Brazil, Rio Grande do Sul
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Canada, Ontario
Windsor Professional Research
Windsor, Ontario, Canada, N8X 3V6
Finchlea Medical Group
Brampton, Ontario, Canada, L6T 3J1
Courtice Health Centre
Courtice, Ontario, Canada, L1E 3C3
Parkwood Hospital
London, Ontario, Canada, N6C 5J1
The London Road Diagnostic Clinic and Medical Centre
Sarnia, Ontario, Canada, N7T 4X3
Albany Medical Center
Toronto, Ontario, Canada, M4K 1N5
Czech Republic
I InternÃ- klinika
Ostrava, Czech Republic, 728 80
InternÃ- a diabetologická Outpatient
Ostrava, Czech Republic, 70900
Czech Republic, CZE
Surgery of Diabetology
Melnik, CZE, Czech Republic, 276 01
Diabetologicka Outpatient Surgery of Diabetology
Slany, CZE, Czech Republic, 274 01
Interni oddeleni nemocnice Na Homolce
Praha 5, CZE, Czech Republic, 15031
Mexico
Nuevo Sanatorio Durango
Delegacion Cuauhtemoc, Mexico, 6700
Hospital Angeles de las Lomas
Huixquilucan, Mexico, 52760
Mexico, DF
Hospital Angeles Mocel
Mexico City, DF, Mexico, 06726
Mexico, MX
Mexican Institute of Clinical Research
Mexico City, MX, Mexico, 06700
Poland
Oddzial Kliniczny Diabetologii (009) Kliniczny nr 1 im Norberta Barlickiego Uniwersytety Meycznego
Lodz, Poland, 90-153
Poland, POL
NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny
Bialystok, POL, Poland, 15-435
Klinika Endocrinologii Diabetologii I
Bialystock, POL, Poland, 15-276
III Oddzial Chorob Wewnetrznych Szpital
Krakow, POL, Poland, 31121
Dzial Badan Klinicznych Malopoiskie
Krakow, POL, Poland, 30 510
Poland, Zgierz
Oddzial Chorob Wewnetrznych Wojewodzki
Lodz, Zgierz, Poland, 95-100
Russian Federation
City Clinical Hospital # 61
Moscow, Russian Federation, 119 048
Central Clinical Hospital of Russian Science Academy
Moscow, Russian Federation, 117 593
Federal State Institution Pulmonology Research Institute of Federal Agency of HC&SD
Moscow, Russian Federation, 105077
St Petersburg Medical Academy (Ilkovich)
St Petersburg, Russian Federation
City Clinical Hospital #64 Center of Applied Clinical Paharmacology Friendship University
Moscow, Russian Federation, 117 198
Russian Scientific Center of Restoration Medicine & Balneology
Moscow, Russian Federation, 121069
Russian Federation, RUS
Smolensk Medical Academy Smolensk Regional Clinical Hospital
Smolensk, RUS, Russian Federation, 214018
Yaroslavl Municipal Health Care Institution Clinical Hospital for Emergency Care na NV Soloviev
Yaroslavl, RUS, Russian Federation, 150003
Central Medical Sanitary Unit #122
St Petersburg, RUS, Russian Federation, 194291
NI Principal Military Clinical Hospital n a academician N.N. Burdenko
Moscow, RUS, Russian Federation, 105229
Moscow State Medico-Stomatological University City Hospital # 23
Moscow, RUS, Russian Federation, 109240
City Hospital # 2 Endocrinology Department
St. Petersburg, RUS, Russian Federation, 194354
NHI Kemerovo Regional Clinical Hospital
Kemerovo, RUS, Russian Federation, 650061
Spain
Hospital 2 de Maig
Barcelona, Spain, 30108025
Ukraine, UKR
Chair Family Med of National Med University
Kiev, UKR, Ukraine, 04050
Railway Clinical Hospital on Donetsk Station
Donetsk, UKR, Ukraine, 83114
Donetsk State Medical University
Donetsk, UKR, Ukraine, 83003
Donetsk State Medical University
Donetsk, UKR, Ukraine, 83009
Institute of Endocrinology and Metabolism
Kiev, UKR, Ukraine, 04114
United Kingdom
Addenbrooke's Hospital Department of Medicine
Cambridge, United Kingdom, CB2 2QQ
United Kingdom, GBR
Birmingham Heartland Hospital
West Midlands, GBR, United Kingdom, B9 5SS
Northern General Hospital
Sheffield, GBR, United Kingdom, S5 7AU
Clinical Research Centre The Royal London Hospital
London, GBR, United Kingdom, E1 2AT
Sponsors and Collaborators
Mannkind Corporation
  More Information

No publications provided

Study ID Numbers: MKC-TI-105
Study First Received: June 1, 2006
Last Updated: October 12, 2009
ClinicalTrials.gov Identifier: NCT00332826     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Mannkind Corporation:
Inhaled insulin
Diabetes Type I and II with Asthma

Additional relevant MeSH terms:
Autoimmune Diseases
Metabolic Diseases
Bronchial Diseases
Immune System Diseases
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Asthma
Pharmacologic Actions
Insulin
Lung Diseases, Obstructive
Hypersensitivity
Hypoglycemic Agents
Diabetes Mellitus, Type 1
Respiratory Tract Diseases
Lung Diseases
Diabetes Mellitus, Type 2
Hypersensitivity, Immediate
Glucose Metabolism Disorders
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on November 27, 2009