Back to resultsInhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma
Primary Purpose
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Asthma
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Technosphere Insulin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Inhaled insulin, Diabetes Type I and II with 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
Sites / Locations
- Arizona Research Center
- Northwest Medical Center
- Premiere Pharmaceutical Research LLC
- Canyon Internal Medicine
- Associated Pharmaceutical Research Center Inc
- Family Medical Center
- Health Care Partners Medical Group
- Golden Pine Clinical Research
- Keck USC School of Medicine
- Pinaccle Trials Inc (SMO)
- Executive Health and Research Associates Inc
- Atlanta Pharmaceutical Research Center
- Southeastern Endocrine & Diabetes
- Cedar-Crosse Research Center
- Franklin Square Hospital
- Healthcare Research
- MedEx Healthcare Research Inc(009)
- Billings Clinic Research Division
- Your Doctors Care
- Hopewell Valley Family Medicine PA
- Eastside Comprehensive Medical Center
- Carolinas Research
- Cleveland Clinic Dept of Endocrinology
- Diabetes & Glandular Disease Research Assoc PA
- McLennan County Medical Education and Research Foundation
- DIM (Clinica Privada)
- Ins De Inv Cardiovascular La Plata
- Hospital de Clinicas de Porto Alegre
- Irmandade da Santa Casa de Misericordia de Porto Alegre
- Hospital Sao Lucas - PUCRS (Fritscher)
- Hospital Nossa Senhora da Conceicao
- Ccbr Brasil Centro de Analises e Pesquisas Clinicas Ltda
- CPClin-Centro de Pesquisas Clinicas
- Clinica de Endocrinologia
- Finchlea Medical Group
- Courtice Health Centre
- Parkwood Hospital
- The London Road Diagnostic Clinic and Medical Centre
- Albany Medical Center
- Windsor Professional Research
- Surgery of Diabetology
- Interni oddeleni nemocnice Na Homolce
- Diabetologicka Outpatient Surgery of Diabetology
- InternÃ- a diabetologická Outpatient
- I InternÃ- klinika
- Hospital Angeles Mocel
- Mexican Institute of Clinical Research
- Nuevo Sanatorio Durango
- Hospital Angeles de las Lomas
- Klinika Endocrinologii Diabetologii I
- NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny
- Dzial Badan Klinicznych Malopoiskie
- III Oddzial Chorob Wewnetrznych Szpital
- Oddzial Chorob Wewnetrznych Wojewodzki
- Oddzial Kliniczny Diabetologii (009) Kliniczny nr 1 im Norberta Barlickiego Uniwersytety Meycznego
- NHI Kemerovo Regional Clinical Hospital
- NI Principal Military Clinical Hospital n a academician N.N. Burdenko
- Moscow State Medico-Stomatological University City Hospital # 23
- Smolensk Medical Academy Smolensk Regional Clinical Hospital
- Central Medical Sanitary Unit #122
- City Hospital # 2 Endocrinology Department
- Yaroslavl Municipal Health Care Institution Clinical Hospital for Emergency Care na NV Soloviev
- Federal State Institution Pulmonology Research Institute of Federal Agency of HC&SD
- City Clinical Hospital #64 Center of Applied Clinical Paharmacology Friendship University
- Central Clinical Hospital of Russian Science Academy
- City Clinical Hospital # 61
- Russian Scientific Center of Restoration Medicine & Balneology
- St Petersburg Medical Academy (Ilkovich)
- Hospital 2 de Maig
- Donetsk State Medical University
- Donetsk State Medical University
- Railway Clinical Hospital on Donetsk Station
- Chair Family Med of National Med University
- Institute of Endocrinology and Metabolism
- Clinical Research Centre The Royal London Hospital
- Northern General Hospital
- Birmingham Heartland Hospital
- Addenbrooke's Hospital Department of Medicine
Outcomes
Primary Outcome Measures
The primary safety outcome will be measurements of post bronchodilator FEV1 throughout the treatment period
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00332826
Brief Title
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
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Terminated
Why Stopped
Non-safety related business decision to combine special population protocols
Study Start Date
June 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mannkind Corporation
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Asthma
Keywords
Inhaled insulin, Diabetes Type I and II with Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Technosphere Insulin
Primary Outcome Measure Information:
Title
The primary safety outcome will be measurements of post bronchodilator FEV1 throughout the treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Northwest Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85029
Country
United States
Facility Name
Premiere Pharmaceutical Research LLC
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Canyon Internal Medicine
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Associated Pharmaceutical Research Center Inc
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
Family Medical Center
City
Foothill Ranch
State/Province
California
ZIP/Postal Code
92610
Country
United States
Facility Name
Health Care Partners Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Golden Pine Clinical Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
Keck USC School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Pinaccle Trials Inc (SMO)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Executive Health and Research Associates Inc
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Atlanta Pharmaceutical Research Center
City
Dunwoody
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Southeastern Endocrine & Diabetes
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Cedar-Crosse Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Franklin Square Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Healthcare Research
City
Florissant
State/Province
Missouri
ZIP/Postal Code
63031
Country
United States
Facility Name
MedEx Healthcare Research Inc(009)
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Billings Clinic Research Division
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Your Doctors Care
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Facility Name
Hopewell Valley Family Medicine PA
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08618
Country
United States
Facility Name
Eastside Comprehensive Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Carolinas Research
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Cleveland Clinic Dept of Endocrinology
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Diabetes & Glandular Disease Research Assoc PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
McLennan County Medical Education and Research Foundation
City
Waco
State/Province
Texas
ZIP/Postal Code
76707
Country
United States
Facility Name
DIM (Clinica Privada)
City
Buenos Aires
ZIP/Postal Code
1704
Country
Argentina
Facility Name
Ins De Inv Cardiovascular La Plata
City
La Plata
Country
Argentina
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Irmandade da Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90035-070
Country
Brazil
Facility Name
Hospital Sao Lucas - PUCRS (Fritscher)
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceicao
City
Porto Alegre
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Ccbr Brasil Centro de Analises e Pesquisas Clinicas Ltda
City
Rio de Janeiro
ZIP/Postal Code
22271-100
Country
Brazil
Facility Name
CPClin-Centro de Pesquisas Clinicas
City
Sao Paulo
ZIP/Postal Code
01244-030
Country
Brazil
Facility Name
Clinica de Endocrinologia
City
Sao Paulo
ZIP/Postal Code
01323-001
Country
Brazil
Facility Name
Finchlea Medical Group
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 3J1
Country
Canada
Facility Name
Courtice Health Centre
City
Courtice
State/Province
Ontario
ZIP/Postal Code
L1E 3C3
Country
Canada
Facility Name
Parkwood Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 5J1
Country
Canada
Facility Name
The London Road Diagnostic Clinic and Medical Centre
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Albany Medical Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4K 1N5
Country
Canada
Facility Name
Windsor Professional Research
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 3V6
Country
Canada
Facility Name
Surgery of Diabetology
City
Melnik
State/Province
CZE
ZIP/Postal Code
276 01
Country
Czech Republic
Facility Name
Interni oddeleni nemocnice Na Homolce
City
Praha 5
State/Province
CZE
ZIP/Postal Code
15031
Country
Czech Republic
Facility Name
Diabetologicka Outpatient Surgery of Diabetology
City
Slany
State/Province
CZE
ZIP/Postal Code
274 01
Country
Czech Republic
Facility Name
InternÃ- a diabetologická Outpatient
City
Ostrava
ZIP/Postal Code
70900
Country
Czech Republic
Facility Name
I InternÃ- klinika
City
Ostrava
ZIP/Postal Code
728 80
Country
Czech Republic
Facility Name
Hospital Angeles Mocel
City
Mexico City
State/Province
DF
ZIP/Postal Code
06726
Country
Mexico
Facility Name
Mexican Institute of Clinical Research
City
Mexico City
State/Province
MX
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Nuevo Sanatorio Durango
City
Delegacion Cuauhtemoc
ZIP/Postal Code
6700
Country
Mexico
Facility Name
Hospital Angeles de las Lomas
City
Huixquilucan
ZIP/Postal Code
52760
Country
Mexico
Facility Name
Klinika Endocrinologii Diabetologii I
City
Bialystock
State/Province
POL
ZIP/Postal Code
15-276
Country
Poland
Facility Name
NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny
City
Bialystok
State/Province
POL
ZIP/Postal Code
15-435
Country
Poland
Facility Name
Dzial Badan Klinicznych Malopoiskie
City
Krakow
State/Province
POL
ZIP/Postal Code
30 510
Country
Poland
Facility Name
III Oddzial Chorob Wewnetrznych Szpital
City
Krakow
State/Province
POL
ZIP/Postal Code
31121
Country
Poland
Facility Name
Oddzial Chorob Wewnetrznych Wojewodzki
City
Lodz
State/Province
Zgierz
ZIP/Postal Code
95-100
Country
Poland
Facility Name
Oddzial Kliniczny Diabetologii (009) Kliniczny nr 1 im Norberta Barlickiego Uniwersytety Meycznego
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
NHI Kemerovo Regional Clinical Hospital
City
Kemerovo
State/Province
RUS
ZIP/Postal Code
650061
Country
Russian Federation
Facility Name
NI Principal Military Clinical Hospital n a academician N.N. Burdenko
City
Moscow
State/Province
RUS
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
Moscow State Medico-Stomatological University City Hospital # 23
City
Moscow
State/Province
RUS
ZIP/Postal Code
109240
Country
Russian Federation
Facility Name
Smolensk Medical Academy Smolensk Regional Clinical Hospital
City
Smolensk
State/Province
RUS
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
Central Medical Sanitary Unit #122
City
St Petersburg
State/Province
RUS
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
City Hospital # 2 Endocrinology Department
City
St. Petersburg
State/Province
RUS
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Yaroslavl Municipal Health Care Institution Clinical Hospital for Emergency Care na NV Soloviev
City
Yaroslavl
State/Province
RUS
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Federal State Institution Pulmonology Research Institute of Federal Agency of HC&SD
City
Moscow
ZIP/Postal Code
105077
Country
Russian Federation
Facility Name
City Clinical Hospital #64 Center of Applied Clinical Paharmacology Friendship University
City
Moscow
ZIP/Postal Code
117 198
Country
Russian Federation
Facility Name
Central Clinical Hospital of Russian Science Academy
City
Moscow
ZIP/Postal Code
117 593
Country
Russian Federation
Facility Name
City Clinical Hospital # 61
City
Moscow
ZIP/Postal Code
119 048
Country
Russian Federation
Facility Name
Russian Scientific Center of Restoration Medicine & Balneology
City
Moscow
ZIP/Postal Code
121069
Country
Russian Federation
Facility Name
St Petersburg Medical Academy (Ilkovich)
City
St Petersburg
Country
Russian Federation
Facility Name
Hospital 2 de Maig
City
Barcelona
ZIP/Postal Code
30108025
Country
Spain
Facility Name
Donetsk State Medical University
City
Donetsk
State/Province
UKR
ZIP/Postal Code
83003
Country
Ukraine
Facility Name
Donetsk State Medical University
City
Donetsk
State/Province
UKR
ZIP/Postal Code
83009
Country
Ukraine
Facility Name
Railway Clinical Hospital on Donetsk Station
City
Donetsk
State/Province
UKR
ZIP/Postal Code
83114
Country
Ukraine
Facility Name
Chair Family Med of National Med University
City
Kiev
State/Province
UKR
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
Institute of Endocrinology and Metabolism
City
Kiev
State/Province
UKR
ZIP/Postal Code
04114
Country
Ukraine
Facility Name
Clinical Research Centre The Royal London Hospital
City
London
State/Province
GBR
ZIP/Postal Code
E1 2AT
Country
United Kingdom
Facility Name
Northern General Hospital
City
Sheffield
State/Province
GBR
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Facility Name
Birmingham Heartland Hospital
City
West Midlands
State/Province
GBR
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Addenbrooke's Hospital Department of Medicine
City
Cambridge
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma
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