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Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes

Primary Purpose

Diabetes, Type 1, Diabetes, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Technosphere® Insulin Inhalation Powder
Usual Care
Sponsored by
Mannkind Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes, Type 1

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: For All Subjects: Nonsmoking Body mass index <42 kg/m2 FEV1 greater than or equal to 70% of predicted , DLco and TLC greater than or equal to 80% of predicted at screening, No abnormalities in screening pulmonary radiology For Subjects with diabetes mellitus: Type 1 or type 2 diabetes for at least 2 years HbA1c greater than or equal to 6.6 % and less than or equal to 12.0 % For Subjects without abnormalities in glucose control: No history of diabetes Normal results from a formal glucose tolerance test Exclusion Criteria: History of chronic obstructive pulmonary disease, asthma, or other significant pulmonary disease Significant renal, hepatic, or cardiac disease Women who are pregnant, lactating, or planning on becoming pregnant Subjects who have participated in studies of other investigational drugs within the previous 3 months Evidence of severe complications of diabetes

Sites / Locations

  • Southwest Health Ltd Research Division
  • Lovelace Scientific Resources
  • Northwest Medical Center
  • Arizona Center for Clinical Research
  • Premiere Pharmaceutical Research LLC
  • Canyon Clinical Research
  • Arizona Research Associates
  • Private Practice
  • Saint Agnes Medical Center
  • Valley Research
  • (Private Practice)
  • Diabetes/Lipid Management Center
  • Interlink Research Institute
  • Diabetes Care Center
  • San Diego Sports Medicine and Family Health Center
  • Dorothy L & James E Frank Diabetes Research Institute
  • Sansum Medical Research Institute
  • Encompass Clinical Research
  • Kaiser Permanente
  • Denver VA Medical Center
  • Alliance Medical Group of Greater Waterbury
  • New Britain General Hosptal c?o Betsy Keller
  • Chase Medical Research, LLC
  • Perimeter Institute for Clinical Research (PICR)
  • Executive Health and Research Associates Inc
  • Rockdale Medical Research Associates
  • Private Practice
  • Atlanta Pharmaceutical Research Center
  • North Atlanta Endocrinology & Diabetes PC
  • Southeastern Endocrine & Diabetes
  • Fox Valley Clinical Research Center LLC
  • Cedar-Crosse Research Center
  • Deerbrook Medical Associates
  • Medical Research of Louisiana
  • Ochsner Clinic and Foundation
  • Health Trends Research LLC
  • Franklin Square Hospital
  • MODEL Clinical Research
  • East Coast Clinical Research Inc
  • Clinical Research
  • Michigan Institute of Medicine
  • PPS Clinical Research / Southwest Medical Center
  • Healthcare Research
  • MedEx Healthcare Research Inc
  • Washington University School of Medicine
  • Mercy Health Research
  • Billings Clinic Research Division
  • Your Doctors Care
  • Hopewell Valley Family Medicine PA
  • Umdnj-Som
  • New Mexico Clinical Research & Osteoporosis Center
  • Lovelace Scientific Resources (Albuquerque)
  • Southwest Endocrinology Associates
  • Physicians Associates of Park Place
  • Diabetes Care & Information Center of New York
  • Eastside Comprehensive Medical Center
  • M.E.R.I.
  • Physicians Clinical Research Service (PCRS) (SMO)
  • Metrolina Medical Research
  • Endocrine Research - Physician's East PA
  • Rapid Medical Research Inc
  • Your Diabetes Endocrine Nutrition Group
  • New Hope Research of Oregon
  • Buckingham Family Medicine
  • Bucks County Clinical Research
  • Upstate Pharmaceutical Research
  • Texas Familicare Clinical Research
  • Dallas Diabetes & Endocrine Center
  • University of Texas Southwestern Medical Center
  • Houston Medical Research Associates
  • North Texas Medical Research
  • Diabetes & Glandular Disease Research Assoc PA
  • Scott & White Hospital and Clinic
  • McLennan County Medical Education and Research Foundation
  • Magna Center for Family Medicine
  • Davis Family Practice
  • Radiant Research Salt Lake City
  • Southeastern PA Med Inst LLC (SMO)
  • Granger Medical Clinic
  • Hampton Roads Center for Clinical Research Inc
  • Rainier Clinical Research Center Inc
  • Clinical Research Department Wenatchee Valley Medical Center
  • Finchlea Medical Group
  • Courtice Health Centre
  • Parkwood Hospital
  • Quest Clinical Trials
  • Sarnia Institute of Clinical Research
  • The London Road Diagnostic Clinic and Medical Centre
  • Lifestyle Metabolism Center
  • Albany Medical Center
  • Lifestyle Metabolism Center (600-118 Eglinton Ave W)
  • Manna Research
  • Diabetologicka ambulance
  • Surgery of Diabetology
  • Internal Clinic
  • Diabetologicka a interni ambulance
  • Diabetologicka a interni ambulance
  • Surgery of Diabetology Petrovice
  • FN Motol Interni Klinika
  • Klinika Endocrinologii Diabetologii I
  • Oddzial Chorob Wewnetrznych
  • Dzial Badan Klinicznych Malopoiskie
  • Endokrynologiczno Metaboliczne DIAB_ENDO_MET
  • III Oddzial Chorob Wewnetrznych Szpital
  • Oddzial Internistyczny Specjalistyczna
  • Oddzial Wewnetrzny B
  • Klliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
  • Oddzial Diabetologiczny Centrum
  • Spzital Kolejowy imm Wlodzimierza Roeflera
  • Katedra i Klinika Gastroentereologii i
  • Oddzial Chorob Wewnetznych i Diabetologii
  • ZPZOZ w Otwocku Szpital Miejski
  • Klinika Medycyny Rodzinnej i Chorob
  • Kemerovo State Medical Academy of Ministry of Health
  • NHI Kemerovo Regional Clinical Hospital
  • NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense
  • Russian State Medical University City Hospital # 4
  • NI Endrocrinological Research Centre of RAMS In patient replacing technologies department
  • Russian Academy of Medical Sciences National Research Ctr for Endocrinology Institute of Diabetes
  • Russian State Medical University Central Clinical Hospital Russian Science Academy
  • RAAMS Endocrinology and Diabetology Department
  • SIH of Moscow City Clinical Hopsital #81 Endocrinology and Diabetology
  • NI Moscow Regional Scientific Research Clinical Institute na MF Vladimirsky
  • Municipal Clinical Hospital #13
  • Moscow State Medical-Stomatological University City Clinical Hospital # 23
  • Ryazan State Medical University na academician IP Pavlov
  • NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital
  • Krestovsky Island Medical Institute
  • St Petersburg NHI City Polytclinic #77 City Diabetological Center #4
  • Central Medical Sanitary Unit #122
  • St Petersburg Medical Academy St Elizabeth Hospital
  • Pavlov State Medical Univ of St Petersburg
  • St Petersburg NHI Municipal Multi-Speciality Hospital # 2
  • Clinical Pharm Dept of Yaroslavl Clin Hospital
  • MHI Clinical Hospital for Emergency Care na NV Soloviev
  • NHI Yaroslavl Regional Clinical Hospital
  • Yaroslavl Regional Clinical Hospital
  • Federal State Institution Pulmonology Research Institute of Federal Agency of HC&SD
  • Fundacio Sarda Farriol
  • Fundacion Jimenez Diaz Servicio Endocrinologia y Nutricion
  • Hospital 12 de Octubre Consultas Extremas - Endocrinologia
  • Hospital Universitario de la Paz
  • Hospital Univ Virgen del Rocío Scio Endocrinología Centro de Diagnosticos Pl Baja
  • Hospital Clinic I Provincial
  • Bukovinian State Medical University Dept of Clinical Immun
  • Dniepropetrovsh State Medical Academy
  • Donetsk State Medical University
  • Donetsk State Medical University
  • Railway Clinical Hospital on Donetsk Station
  • V Danilevsky Inst of Endocrinology Pathology
  • Medical University at Kiev Center of Endocrinology and Metab
  • Chair Family Med of National Med University
  • Ukr Scientifically Practical Centre of Endocrine Surgery
  • Lugansk State Medical University Chair of Hosp Therapy #2
  • Lugansk State Medical University Chair of Therapy #1
  • Chair of Endocrin & Clinical Pharmacology of Lvov State Medical University
  • Odessa State Medical University Dept of Gen Practice and Med Rehab
  • Odessa Reg. Clinical Hosp Outpatient Department
  • Odessa State Med Dept of Family Med and Gen Practice
  • Crimean State Medical University Dept of Therapy #1
  • Vinnitsa State Medical University
  • Outpatient Clinic of Family Physician "Rusanovka"
  • Public Institution City Policlinic #20 Odessa
  • Barnsley Hospital
  • Kingthorne Group Practice
  • Manny Cussins Centre
  • Royal liverpool University Hospital
  • Clinical Research Centre The Royal London Hospital
  • Medinova Research Mount Vernon Hospital
  • Edith Cavel Hospital Diabetes Centre
  • Northern General Hospital
  • Woolpit Medical Practice
  • West Suffolk Hospital
  • Birmingham Heartland Hospital
  • Bradford Hospital Dept of Diabetes & Endocrinology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

No Intervention

Arm Label

TI Inhalation Powder

Usual care

Non-diabetes

Arm Description

Technosphere® Insulin Inhalation Powder

Usual care

Subjects without abnormalities in glucose control (Note: Hypoglycemia and HbA1c were not reported for this group)

Outcomes

Primary Outcome Measures

Change From Baseline to Month 24 in Forced Expiratory Volume in 1 Second (FEV1) by MMRM for TI vs Usual Care
Change from Baseline to End of Study in FEV1 by MMRM
FEV1 Decrease of ≥ 15% From Baseline Value at Last Measurement for TI vs Usual Care
FEV1 decrease of ≥ 15% from Baseline value at last measurement

Secondary Outcome Measures

Change From Baseline to Last Measurement in FEV1 for TI vs Usual Care
Change from Baseline to last measurement(Month 24) in FEV1
Change From Baseline to Month 24 in Forced Vital Capacity (FVC) by MMRM
Change from Baseline to Month 24 in FVC by MMRM
Change From Baseline to Month 24 in Total Lung Capacity (TLC) by MMRM
Change from baseline to Month 24 in TLC by MMRM
Change From Baseline to Month 24 in Hemoglobin Corrected DLco by MMRM
Change from baseline to Month 24 in hemoglobin-corrected DLco by MMRM
Forced Vital Capacity (FVC) Decrease of ≥ 15% From Baseline Value at Last Measurement
FVC Decrease of ≥15% from Baseline Value at Last Measurement
Total Lung Capacity (TLC) Decrease of ≥ 15% From Baseline Value at Last Measurement
TLC Decrease of ≥ 15% from Baseline Value at Last Measurement
Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of ≥ 15% From Baseline Value at Last Measurement
Hemoglobin-corrected DLco decrease of ≥ 15% from baseline value at last measurement
Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of >3 ml/Min/mmHg From Baseline Value at Last Measurement
Hemoglobin-corrected DLco decrease of >3 ml/min/mmHg from baseline value at last measurement
Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Last Measurement for TI vs Usual Care
Change from baseline in HbA1c at last measurement
Change in Weight From Baseline at Month 24
Change from baseline in weight at Month 24

Full Information

First Posted
March 28, 2006
Last Updated
October 9, 2014
Sponsor
Mannkind Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00308737
Brief Title
Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes
Official Title
Pulmonary Outcomes Within a 2-Year Period in Subjects With Diabetes Mellitus Treated With Technosphere /Insulin or Usual Antidiabetic Treatment and in Subjects Without Abnormalities in Glucose Control.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mannkind Corporation

4. Oversight

5. Study Description

Brief Summary
Pulmonary Safety in Diabetics with T/I

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Type 1, Diabetes, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2053 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TI Inhalation Powder
Arm Type
Experimental
Arm Description
Technosphere® Insulin Inhalation Powder
Arm Title
Usual care
Arm Type
Other
Arm Description
Usual care
Arm Title
Non-diabetes
Arm Type
No Intervention
Arm Description
Subjects without abnormalities in glucose control (Note: Hypoglycemia and HbA1c were not reported for this group)
Intervention Type
Drug
Intervention Name(s)
Technosphere® Insulin Inhalation Powder
Intervention Description
Inhalation, 15U/30U
Intervention Type
Drug
Intervention Name(s)
Usual Care
Intervention Description
Subjects will receive antidiabetes treatment at the discretion of their physicians
Primary Outcome Measure Information:
Title
Change From Baseline to Month 24 in Forced Expiratory Volume in 1 Second (FEV1) by MMRM for TI vs Usual Care
Description
Change from Baseline to End of Study in FEV1 by MMRM
Time Frame
Baseline to Month 24
Title
FEV1 Decrease of ≥ 15% From Baseline Value at Last Measurement for TI vs Usual Care
Description
FEV1 decrease of ≥ 15% from Baseline value at last measurement
Time Frame
Baseline to Month 24
Secondary Outcome Measure Information:
Title
Change From Baseline to Last Measurement in FEV1 for TI vs Usual Care
Description
Change from Baseline to last measurement(Month 24) in FEV1
Time Frame
Baseline to Month 24
Title
Change From Baseline to Month 24 in Forced Vital Capacity (FVC) by MMRM
Description
Change from Baseline to Month 24 in FVC by MMRM
Time Frame
Baseline to Month 24
Title
Change From Baseline to Month 24 in Total Lung Capacity (TLC) by MMRM
Description
Change from baseline to Month 24 in TLC by MMRM
Time Frame
Baseline to Month 24
Title
Change From Baseline to Month 24 in Hemoglobin Corrected DLco by MMRM
Description
Change from baseline to Month 24 in hemoglobin-corrected DLco by MMRM
Time Frame
Baseline to Month 24
Title
Forced Vital Capacity (FVC) Decrease of ≥ 15% From Baseline Value at Last Measurement
Description
FVC Decrease of ≥15% from Baseline Value at Last Measurement
Time Frame
Baseline to Month 24
Title
Total Lung Capacity (TLC) Decrease of ≥ 15% From Baseline Value at Last Measurement
Description
TLC Decrease of ≥ 15% from Baseline Value at Last Measurement
Time Frame
Baseline to Month 24
Title
Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of ≥ 15% From Baseline Value at Last Measurement
Description
Hemoglobin-corrected DLco decrease of ≥ 15% from baseline value at last measurement
Time Frame
Baseline to Month 24
Title
Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of >3 ml/Min/mmHg From Baseline Value at Last Measurement
Description
Hemoglobin-corrected DLco decrease of >3 ml/min/mmHg from baseline value at last measurement
Time Frame
Baseline to Month 24
Title
Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Last Measurement for TI vs Usual Care
Description
Change from baseline in HbA1c at last measurement
Time Frame
Baseline to Month 24
Title
Change in Weight From Baseline at Month 24
Description
Change from baseline in weight at Month 24
Time Frame
Baseline to Month 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: For All Subjects: Nonsmoking Body mass index <42 kg/m2 FEV1 greater than or equal to 70% of predicted , DLco and TLC greater than or equal to 80% of predicted at screening, No abnormalities in screening pulmonary radiology For Subjects with diabetes mellitus: Type 1 or type 2 diabetes for at least 2 years HbA1c greater than or equal to 6.6 % and less than or equal to 12.0 % For Subjects without abnormalities in glucose control: No history of diabetes Normal results from a formal glucose tolerance test Exclusion Criteria: History of chronic obstructive pulmonary disease, asthma, or other significant pulmonary disease Significant renal, hepatic, or cardiac disease Women who are pregnant, lactating, or planning on becoming pregnant Subjects who have participated in studies of other investigational drugs within the previous 3 months Evidence of severe complications of diabetes
Facility Information:
Facility Name
Southwest Health Ltd Research Division
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Lovelace Scientific Resources
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Northwest Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85029
Country
United States
Facility Name
Arizona Center for Clinical Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Premiere Pharmaceutical Research LLC
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Canyon Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Arizona Research Associates
City
Tuscon
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Private Practice
City
Burlingame
State/Province
California
ZIP/Postal Code
94010
Country
United States
Facility Name
Saint Agnes Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Valley Research
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
(Private Practice)
City
Garden Grove
State/Province
California
ZIP/Postal Code
92840
Country
United States
Facility Name
Diabetes/Lipid Management Center
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
Interlink Research Institute
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Diabetes Care Center
City
Salinas
State/Province
California
ZIP/Postal Code
93901
Country
United States
Facility Name
San Diego Sports Medicine and Family Health Center
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Dorothy L & James E Frank Diabetes Research Institute
City
San Mateo
State/Province
California
ZIP/Postal Code
94401
Country
United States
Facility Name
Sansum Medical Research Institute
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Encompass Clinical Research
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Kaiser Permanente
City
Denver
State/Province
Colorado
ZIP/Postal Code
80205
Country
United States
Facility Name
Denver VA Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Alliance Medical Group of Greater Waterbury
City
Middlebury
State/Province
Connecticut
ZIP/Postal Code
06762
Country
United States
Facility Name
New Britain General Hosptal c?o Betsy Keller
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States
Facility Name
Chase Medical Research, LLC
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Perimeter Institute for Clinical Research (PICR)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
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
Rockdale Medical Research Associates
City
Conyers
State/Province
Georgia
ZIP/Postal Code
30094
Country
United States
Facility Name
Private Practice
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30035-4000
Country
United States
Facility Name
Atlanta Pharmaceutical Research Center
City
Dunwoody
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
North Atlanta Endocrinology & Diabetes PC
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30045
Country
United States
Facility Name
Southeastern Endocrine & Diabetes
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Fox Valley Clinical Research Center LLC
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
Facility Name
Cedar-Crosse Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Deerbrook Medical Associates
City
Vernon Hills
State/Province
Illinois
ZIP/Postal Code
60061
Country
United States
Facility Name
Medical Research of Louisiana
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Facility Name
Ochsner Clinic and Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Health Trends Research LLC
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208-6391
Country
United States
Facility Name
Franklin Square Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
MODEL Clinical Research
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
East Coast Clinical Research Inc
City
Haverhill
State/Province
Massachusetts
ZIP/Postal Code
01830
Country
United States
Facility Name
Clinical Research
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02453
Country
United States
Facility Name
Michigan Institute of Medicine
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48152
Country
United States
Facility Name
PPS Clinical Research / Southwest Medical Center
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
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
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Mercy Health Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
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
Umdnj-Som
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08084
Country
United States
Facility Name
New Mexico Clinical Research & Osteoporosis Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Lovelace Scientific Resources (Albuquerque)
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Southwest Endocrinology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Physicians Associates of Park Place
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11216
Country
United States
Facility Name
Diabetes Care & Information Center of New York
City
Flushing
State/Province
New York
ZIP/Postal Code
11365
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
M.E.R.I.
City
New York
State/Province
New York
ZIP/Postal Code
10023
Country
United States
Facility Name
Physicians Clinical Research Service (PCRS) (SMO)
City
White Plains
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Metrolina Medical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Endocrine Research - Physician's East PA
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Rapid Medical Research Inc
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Your Diabetes Endocrine Nutrition Group
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
New Hope Research of Oregon
City
Portland
State/Province
Oregon
ZIP/Postal Code
97219
Country
United States
Facility Name
Buckingham Family Medicine
City
Doyleston
State/Province
Pennsylvania
ZIP/Postal Code
18912
Country
United States
Facility Name
Bucks County Clinical Research
City
Morrisville
State/Province
Pennsylvania
ZIP/Postal Code
19067
Country
United States
Facility Name
Upstate Pharmaceutical Research
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Texas Familicare Clinical Research
City
Colleyville
State/Province
Texas
ZIP/Postal Code
76034
Country
United States
Facility Name
Dallas Diabetes & Endocrine Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Houston Medical Research Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
North Texas Medical Research
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
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
Scott & White Hospital and Clinic
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
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
Magna Center for Family Medicine
City
Magna
State/Province
Utah
ZIP/Postal Code
84044
Country
United States
Facility Name
Davis Family Practice
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Radiant Research Salt Lake City
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Southeastern PA Med Inst LLC (SMO)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Granger Medical Clinic
City
West Valley City
State/Province
Utah
ZIP/Postal Code
84120
Country
United States
Facility Name
Hampton Roads Center for Clinical Research Inc
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Rainier Clinical Research Center Inc
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
Facility Name
Clinical Research Department Wenatchee Valley Medical Center
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Finchlea Medical Group
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 3J1
Country
Canada
Facility Name
Courtice Health Centre
City
Courtice, Ontario
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
Quest Clinical Trials
City
Markham
State/Province
Ontario
ZIP/Postal Code
L6B 1A1
Country
Canada
Facility Name
Sarnia Institute of Clinical Research
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
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
Lifestyle Metabolism Center
City
Thornhill
State/Province
Ontario
ZIP/Postal Code
L4J 8L7
Country
Canada
Facility Name
Albany Medical Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4K 1N5
Country
Canada
Facility Name
Lifestyle Metabolism Center (600-118 Eglinton Ave W)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4R 2G4
Country
Canada
Facility Name
Manna Research
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
Facility Name
Diabetologicka ambulance
City
Litomerice
State/Province
CZE
ZIP/Postal Code
41201
Country
Czech Republic
Facility Name
Surgery of Diabetology
City
Melnik
State/Province
CZE
ZIP/Postal Code
276 01
Country
Czech Republic
Facility Name
Internal Clinic
City
Ostrava - Poruba
State/Province
CZE
ZIP/Postal Code
708 52
Country
Czech Republic
Facility Name
Diabetologicka a interni ambulance
City
Ostrava 1
State/Province
CZE
ZIP/Postal Code
70200
Country
Czech Republic
Facility Name
Diabetologicka a interni ambulance
City
Ostrava-Kuncice
State/Province
CZE
ZIP/Postal Code
70702
Country
Czech Republic
Facility Name
Surgery of Diabetology Petrovice
City
Prague 15
State/Province
CZE
ZIP/Postal Code
109 00
Country
Czech Republic
Facility Name
FN Motol Interni Klinika
City
Praha 6
State/Province
CZE
ZIP/Postal Code
150 06
Country
Czech Republic
Facility Name
Klinika Endocrinologii Diabetologii I
City
Bialystock
State/Province
POL
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Oddzial Chorob Wewnetrznych
City
Bialystock
State/Province
POL
ZIP/Postal Code
15-950
Country
Poland
Facility Name
Dzial Badan Klinicznych Malopoiskie
City
Krakow
State/Province
POL
ZIP/Postal Code
30 510
Country
Poland
Facility Name
Endokrynologiczno Metaboliczne DIAB_ENDO_MET
City
Krakow
State/Province
POL
ZIP/Postal Code
31-261
Country
Poland
Facility Name
III Oddzial Chorob Wewnetrznych Szpital
City
Krakow
State/Province
POL
ZIP/Postal Code
31121
Country
Poland
Facility Name
Oddzial Internistyczny Specjalistyczna
City
Lask
State/Province
POL
ZIP/Postal Code
98-100
Country
Poland
Facility Name
Oddzial Wewnetrzny B
City
Lodz
State/Province
POL
ZIP/Postal Code
092-003
Country
Poland
Facility Name
Klliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
City
Lodz
State/Province
POL
ZIP/Postal Code
90 153
Country
Poland
Facility Name
Oddzial Diabetologiczny Centrum
City
Lodz
State/Province
POL
ZIP/Postal Code
93-338
Country
Poland
Facility Name
Spzital Kolejowy imm Wlodzimierza Roeflera
City
Pruszkow
State/Province
POL
ZIP/Postal Code
05-800
Country
Poland
Facility Name
Katedra i Klinika Gastroentereologii i
City
Warsaw
State/Province
POL
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Oddzial Chorob Wewnetznych i Diabetologii
City
Warsaw
State/Province
POL
ZIP/Postal Code
02-507
Country
Poland
Facility Name
ZPZOZ w Otwocku Szpital Miejski
City
Warsaw
State/Province
POL
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Klinika Medycyny Rodzinnej i Chorob
City
Warszawa
State/Province
POL
ZIP/Postal Code
00-416
Country
Poland
Facility Name
Kemerovo State Medical Academy of Ministry of Health
City
Kemerovo
State/Province
RUS
ZIP/Postal Code
650061
Country
Russian Federation
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 of the Ministry of Defense
City
Moscow
State/Province
RUS
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
Russian State Medical University City Hospital # 4
City
Moscow
State/Province
RUS
ZIP/Postal Code
113093
Country
Russian Federation
Facility Name
NI Endrocrinological Research Centre of RAMS In patient replacing technologies department
City
Moscow
State/Province
RUS
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Russian Academy of Medical Sciences National Research Ctr for Endocrinology Institute of Diabetes
City
Moscow
State/Province
RUS
ZIP/Postal Code
117036
Country
Russian Federation
Facility Name
Russian State Medical University Central Clinical Hospital Russian Science Academy
City
Moscow
State/Province
RUS
ZIP/Postal Code
117593
Country
Russian Federation
Facility Name
RAAMS Endocrinology and Diabetology Department
City
Moscow
State/Province
RUS
ZIP/Postal Code
125315
Country
Russian Federation
Facility Name
SIH of Moscow City Clinical Hopsital #81 Endocrinology and Diabetology
City
Moscow
State/Province
RUS
ZIP/Postal Code
127644
Country
Russian Federation
Facility Name
NI Moscow Regional Scientific Research Clinical Institute na MF Vladimirsky
City
Moscow
State/Province
RUS
ZIP/Postal Code
129110
Country
Russian Federation
Facility Name
Municipal Clinical Hospital #13
City
Moscow
State/Province
RUS
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
Moscow State Medical-Stomatological University City Clinical Hospital # 23
City
Moscow
State/Province
RUS
Country
Russian Federation
Facility Name
Ryazan State Medical University na academician IP Pavlov
City
Ryazan
State/Province
RUS
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital
City
Smolensk
State/Province
RUS
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
Krestovsky Island Medical Institute
City
St Petersburg
State/Province
RUS
ZIP/Postal Code
107110
Country
Russian Federation
Facility Name
St Petersburg NHI City Polytclinic #77 City Diabetological Center #4
City
St Petersburg
State/Province
RUS
ZIP/Postal Code
193012
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
St Petersburg Medical Academy St Elizabeth Hospital
City
St Petersburg
State/Province
RUS
ZIP/Postal Code
195257
Country
Russian Federation
Facility Name
Pavlov State Medical Univ of St Petersburg
City
St Petersburg
State/Province
RUS
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
St Petersburg NHI Municipal Multi-Speciality Hospital # 2
City
St. Petersburg
State/Province
RUS
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Clinical Pharm Dept of Yaroslavl Clin Hospital
City
Yaroslavl
State/Province
RUS
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
MHI Clinical Hospital for Emergency Care na NV Soloviev
City
Yaroslavl
State/Province
RUS
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
NHI Yaroslavl Regional Clinical Hospital
City
Yaroslavl
State/Province
RUS
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
Yaroslavl Regional Clinical Hospital
City
Yaroslavl
State/Province
RUS
ZIP/Postal Code
150062
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
Fundacio Sarda Farriol
City
Barcelona
State/Province
ESP
ZIP/Postal Code
08017
Country
Spain
Facility Name
Fundacion Jimenez Diaz Servicio Endocrinologia y Nutricion
City
Madrid
State/Province
ESP
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital 12 de Octubre Consultas Extremas - Endocrinologia
City
Madrid
State/Province
ESP
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario de la Paz
City
Madrid
State/Province
ESP
ZIP/Postal Code
28046
Country
Spain
City
Sevilla
State/Province
ESP
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Univ Virgen del Rocío Scio Endocrinología Centro de Diagnosticos Pl Baja
City
Sevilla
State/Province
ESP
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Clinic I Provincial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Bukovinian State Medical University Dept of Clinical Immun
City
Chernivtcy
State/Province
UKR
ZIP/Postal Code
58022
Country
Ukraine
Facility Name
Dniepropetrovsh State Medical Academy
City
Dniepropetrovsk
State/Province
UKR
ZIP/Postal Code
49023
Country
Ukraine
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
V Danilevsky Inst of Endocrinology Pathology
City
Kharkiv
State/Province
UKR
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Medical University at Kiev Center of Endocrinology and Metab
City
Kiev
State/Province
UKR
ZIP/Postal Code
01004
Country
Ukraine
Facility Name
Chair Family Med of National Med University
City
Kiev
State/Province
UKR
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
Ukr Scientifically Practical Centre of Endocrine Surgery
City
Kiev
State/Province
UKR
ZIP/Postal Code
2175
Country
Ukraine
Facility Name
Lugansk State Medical University Chair of Hosp Therapy #2
City
Lugansk
State/Province
UKR
ZIP/Postal Code
91045
Country
Ukraine
Facility Name
Lugansk State Medical University Chair of Therapy #1
City
Lugansk
State/Province
UKR
ZIP/Postal Code
91045
Country
Ukraine
Facility Name
Chair of Endocrin & Clinical Pharmacology of Lvov State Medical University
City
Lvov
State/Province
UKR
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Odessa State Medical University Dept of Gen Practice and Med Rehab
City
Odessa
State/Province
UKR
ZIP/Postal Code
65009
Country
Ukraine
Facility Name
Odessa Reg. Clinical Hosp Outpatient Department
City
Odessa
State/Province
UKR
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Odessa State Med Dept of Family Med and Gen Practice
City
Odessa
State/Province
UKR
ZIP/Postal Code
65039
Country
Ukraine
Facility Name
Crimean State Medical University Dept of Therapy #1
City
Simferopol
State/Province
UKR
ZIP/Postal Code
95017
Country
Ukraine
Facility Name
Vinnitsa State Medical University
City
Vinnitsa
State/Province
UKR
ZIP/Postal Code
21020
Country
Ukraine
Facility Name
Outpatient Clinic of Family Physician "Rusanovka"
City
Kiev
ZIP/Postal Code
02147
Country
Ukraine
Facility Name
Public Institution City Policlinic #20 Odessa
City
Odessa
ZIP/Postal Code
65114
Country
Ukraine
Facility Name
Barnsley Hospital
City
Barnsley
State/Province
GBR
ZIP/Postal Code
S75 2EP
Country
United Kingdom
Facility Name
Kingthorne Group Practice
City
Doncaster
State/Province
GBR
ZIP/Postal Code
DN3 2LX
Country
United Kingdom
Facility Name
Manny Cussins Centre
City
Leeds
State/Province
GBR
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Royal liverpool University Hospital
City
Liverpool
State/Province
GBR
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Clinical Research Centre The Royal London Hospital
City
London
State/Province
GBR
ZIP/Postal Code
E1 2AT
Country
United Kingdom
Facility Name
Medinova Research Mount Vernon Hospital
City
Middlesex
State/Province
GBR
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Edith Cavel Hospital Diabetes Centre
City
Petersborough
State/Province
GBR
ZIP/Postal Code
PE3 9GZ
Country
United Kingdom
Facility Name
Northern General Hospital
City
Sheffield
State/Province
GBR
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Facility Name
Woolpit Medical Practice
City
Suffolk
State/Province
GBR
ZIP/Postal Code
IP30 9QU
Country
United Kingdom
Facility Name
West Suffolk Hospital
City
Suffolk
State/Province
GBR
ZIP/Postal Code
IP33 2QZ
Country
United Kingdom
Facility Name
Birmingham Heartland Hospital
City
West Midlands
State/Province
GBR
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Bradford Hospital Dept of Diabetes & Endocrinology
City
West Yorkshire
State/Province
GBR
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes

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