AzTrials
AzTrials

Diabetes, Type 1Phase 3NCT00308737

Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes

A Phase 3 study testing Technosphere® Insulin Inhalation Powder in people with Diabetes, Type 1 and Diabetes, Type 2, run by Mannkind Corporation at 176 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Pulmonary Safety in Diabetics with T/I Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes, Type 1, Diabetes, Type 2
What is being tested?
Technosphere® Insulin Inhalation Powder
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,053 participants
Where
176 sitesin 8 countries
Study dates
Jun 2005to Oct 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 11Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

176 sites in 8 countries.

176 sites in 8 countries

United States82 sites

  • New Mexico Clinical Research & Osteoporosis Center

    Albuquerque, New Mexico, 87106

  • Lovelace Scientific Resources (Albuquerque)

    Albuquerque, New Mexico, 87108

  • Southwest Endocrinology Associates

    Albuquerque, New Mexico, 87109

  • Perimeter Institute for Clinical Research (PICR)

    Atlanta, Georgia, 30338

  • Executive Health and Research Associates Inc

    Atlanta, Georgia, 30342

  • Fox Valley Clinical Research Center LLC

    Aurora, Illinois, 60504

  • Health Trends Research LLC

    Baltimore, Maryland, 21208-6391

  • Franklin Square Hospital

    Baltimore, Maryland, 21237

  • Billings Clinic Research Division

    Billings, Montana, 59101

  • Physicians Associates of Park Place

    Brooklyn, New York, 11216

  • Private Practice

    Burlingame, California, 94010

  • Metrolina Medical Research

    Charlotte, North Carolina, 28209

  • PPS Clinical Research / Southwest Medical Center

    Chesterfield, Missouri, 63017

  • Cedar-Crosse Research Center

    Chicago, Illinois, 60607

  • Rapid Medical Research Inc

    Cleveland, Ohio, 44122

  • Texas Familicare Clinical Research

    Colleyville, Texas, 76034

  • Rockdale Medical Research Associates

    Conyers, Georgia, 30094

  • Dallas Diabetes & Endocrine Center

    Dallas, Texas, 75230

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Private Practice

    Decatur, Georgia, 30035-4000

  • Kaiser Permanente

    Denver, Colorado, 80205

  • Denver VA Medical Center

    Denver, Colorado, 80220

  • Buckingham Family Medicine

    Doyleston, Pennsylvania, 18912

  • Atlanta Pharmaceutical Research Center

    Dunwoody, Georgia, 30338

  • Healthcare Research

    Florissant, Missouri, 63031

  • Diabetes Care & Information Center of New York

    Flushing, New York, 11365

  • Saint Agnes Medical Center

    Fresno, California, 93720

  • Valley Research

    Fresno, California, 93720

  • (Private Practice)

    Garden Grove, California, 92840

  • Endocrine Research - Physician's East PA

    Greenville, North Carolina, 27834

  • Upstate Pharmaceutical Research

    Greenville, South Carolina, 29615

  • East Coast Clinical Research Inc

    Haverhill, Massachusetts, 01830

  • Your Doctors Care

    Hillsborough, New Jersey, 08844

  • Houston Medical Research Associates

    Houston, Texas, 77030

  • Diabetes/Lipid Management Center

    Huntington Beach, California, 92648

  • North Atlanta Endocrinology & Diabetes PC

    Lawrenceville, Georgia, 30045

  • Michigan Institute of Medicine

    Livonia, Michigan, 48152

  • Interlink Research Institute

    Los Alamitos, California, 90720

  • Magna Center for Family Medicine

    Magna, Utah, 84044

  • Your Diabetes Endocrine Nutrition Group

    Mentor, Ohio, 44060

  • Medical Research of Louisiana

    Metairie, Louisiana, 70001

  • Alliance Medical Group of Greater Waterbury

    Middlebury, Connecticut, 06762

  • Bucks County Clinical Research

    Morrisville, Pennsylvania, 19067

  • New Britain General Hosptal c?o Betsy Keller

    New Britain, Connecticut, 06050

  • Ochsner Clinic and Foundation

    New Orleans, Louisiana, 70121

  • Eastside Comprehensive Medical Center

    New York, New York, 10021

  • M.E.R.I.

    New York, New York, 10023

  • Hampton Roads Center for Clinical Research Inc

    Norfolk, Virginia, 23502

  • Southwest Health Ltd Research Division

    Phoenix, Arizona, 85016

  • Lovelace Scientific Resources

    Phoenix, Arizona, 85018

  • Northwest Medical Center

    Phoenix, Arizona, 85029

  • Arizona Center for Clinical Research

    Phoenix, Arizona, 85032

  • North Texas Medical Research

    Plano, Texas, 75093

  • New Hope Research of Oregon

    Portland, Oregon, 97219

  • Rainier Clinical Research Center Inc

    Renton, Washington, 98055

  • Southeastern Endocrine & Diabetes

    Roswell, Georgia, 30076

  • Diabetes Care Center

    Salinas, California, 93901

  • Davis Family Practice

    Salt Lake City, Utah, 84041

  • Radiant Research Salt Lake City

    Salt Lake City, Utah, 84107

  • Southeastern PA Med Inst LLC (SMO)

    Salt Lake City, Utah, 84107

  • Diabetes & Glandular Disease Research Assoc PA

    San Antonio, Texas, 78229

  • San Diego Sports Medicine and Family Health Center

    San Diego, California, 92120

  • Dorothy L & James E Frank Diabetes Research Institute

    San Mateo, California, 94401

  • Sansum Medical Research Institute

    Santa Barbara, California, 93105

  • Encompass Clinical Research

    Spring Valley, California, 91978

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • MedEx Healthcare Research Inc

    St Louis, Missouri, 63117

  • Mercy Health Research

    St Louis, Missouri, 63141

  • Premiere Pharmaceutical Research LLC

    Tempe, Arizona, 85282

  • Scott & White Hospital and Clinic

    Temple, Texas, 76508

  • MODEL Clinical Research

    Towson, Maryland, 21204

  • Hopewell Valley Family Medicine PA

    Trenton, New Jersey, 08618

  • Canyon Clinical Research

    Tucson, Arizona, 85712

  • Arizona Research Associates

    Tuscon, Arizona, 85712

  • Deerbrook Medical Associates

    Vernon Hills, Illinois, 60061

  • Umdnj-Som

    Voorhees Township, New Jersey, 08084

  • McLennan County Medical Education and Research Foundation

    Waco, Texas, 76707

  • Clinical Research

    Waltham, Massachusetts, 02453

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • Clinical Research Department Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801

  • Granger Medical Clinic

    West Valley City, Utah, 84120

  • Physicians Clinical Research Service (PCRS) (SMO)

    White Plains, New York, 10604

Other trials in United States

Russia25 sites

  • Kemerovo State Medical Academy of Ministry of Health

    Kemerovo, RUS, 650061

  • NHI Kemerovo Regional Clinical Hospital

    Kemerovo, RUS, 650061

  • NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense

    Moscow, RUS, 105229

  • Russian State Medical University City Hospital # 4

    Moscow, RUS, 113093

  • NI Endrocrinological Research Centre of RAMS In patient replacing technologies department

    Moscow, RUS, 115478

  • Russian Academy of Medical Sciences National Research Ctr for Endocrinology Institute of Diabetes

    Moscow, RUS, 117036

  • Russian State Medical University Central Clinical Hospital Russian Science Academy

    Moscow, RUS, 117593

  • RAAMS Endocrinology and Diabetology Department

    Moscow, RUS, 125315

  • SIH of Moscow City Clinical Hopsital #81 Endocrinology and Diabetology

    Moscow, RUS, 127644

  • NI Moscow Regional Scientific Research Clinical Institute na MF Vladimirsky

    Moscow, RUS, 129110

  • Municipal Clinical Hospital #13

    Moscow, RUS, 150062

  • Moscow State Medical-Stomatological University City Clinical Hospital # 23

    Moscow, RUS

  • Federal State Institution Pulmonology Research Institute of Federal Agency of HC&SD

    Moscow, 105077

  • Ryazan State Medical University na academician IP Pavlov

    Ryazan, RUS, 390026

  • Krestovsky Island Medical Institute

    Saint Petersburg, RUS, 107110

  • St Petersburg NHI City Polytclinic #77 City Diabetological Center #4

    Saint Petersburg, RUS, 193012

  • Central Medical Sanitary Unit #122

    Saint Petersburg, RUS, 194291

  • St Petersburg NHI Municipal Multi-Speciality Hospital # 2

    Saint Petersburg, RUS, 194354

  • St Petersburg Medical Academy St Elizabeth Hospital

    Saint Petersburg, RUS, 195257

  • Pavlov State Medical Univ of St Petersburg

    Saint Petersburg, RUS, 197022

  • NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital

    Smolensk, RUS, 214018

  • Clinical Pharm Dept of Yaroslavl Clin Hospital

    Yaroslavl, RUS, 150003

  • MHI Clinical Hospital for Emergency Care na NV Soloviev

    Yaroslavl, RUS, 150003

  • NHI Yaroslavl Regional Clinical Hospital

    Yaroslavl, RUS, 150062

  • Yaroslavl Regional Clinical Hospital

    Yaroslavl, RUS, 150062

Other trials in Russia

Ukraine19 sites

  • Bukovinian State Medical University Dept of Clinical Immun

    Chernivtcy, UKR, 58022

  • Dniepropetrovsh State Medical Academy

    Dniepropetrovsk, UKR, 49023

  • Donetsk State Medical University

    Donetsk, UKR, 83003

  • Donetsk State Medical University

    Donetsk, UKR, 83009

  • Railway Clinical Hospital on Donetsk Station

    Donetsk, UKR, 83114

  • V Danilevsky Inst of Endocrinology Pathology

    Kharkiv, UKR, 61070

  • Medical University at Kiev Center of Endocrinology and Metab

    Kiev, UKR, 01004

  • Chair Family Med of National Med University

    Kiev, UKR, 04050

  • Ukr Scientifically Practical Centre of Endocrine Surgery

    Kiev, UKR, 2175

  • Outpatient Clinic of Family Physician "Rusanovka"

    Kiev, 02147

  • Lugansk State Medical University Chair of Hosp Therapy #2

    Luhansk, UKR, 91045

  • Lugansk State Medical University Chair of Therapy #1

    Luhansk, UKR, 91045

  • Chair of Endocrin & Clinical Pharmacology of Lvov State Medical University

    Lviv, UKR, 79010

  • Odessa State Medical University Dept of Gen Practice and Med Rehab

    Odesa, UKR, 65009

  • Odessa Reg. Clinical Hosp Outpatient Department

    Odesa, UKR, 65025

  • Odessa State Med Dept of Family Med and Gen Practice

    Odesa, UKR, 65039

  • Public Institution City Policlinic #20 Odessa

    Odesa, 65114

  • Crimean State Medical University Dept of Therapy #1

    Simferopol, UKR, 95017

  • Vinnitsa State Medical University

    Vinnitsa, UKR, 21020

Other trials in Ukraine

Poland14 sites

  • Klinika Endocrinologii Diabetologii I

    Bialystock, POL, 15-276

  • Oddzial Chorob Wewnetrznych

    Bialystock, POL, 15-950

  • Dzial Badan Klinicznych Malopoiskie

    Krakow, POL, 30 510

  • Endokrynologiczno Metaboliczne DIAB_ENDO_MET

    Krakow, POL, 31-261

  • III Oddzial Chorob Wewnetrznych Szpital

    Krakow, POL, 31121

  • Oddzial Internistyczny Specjalistyczna

    Łask, POL, 98-100

  • Oddzial Wewnetrzny B

    Lodz, POL, 092-003

  • Klliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

    Lodz, POL, 90 153

  • Oddzial Diabetologiczny Centrum

    Lodz, POL, 93-338

  • Spzital Kolejowy imm Wlodzimierza Roeflera

    Pruszków, POL, 05-800

  • Klinika Medycyny Rodzinnej i Chorob

    Warsaw, POL, 00-416

  • Katedra i Klinika Gastroentereologii i

    Warsaw, POL, 02-097

  • Oddzial Chorob Wewnetznych i Diabetologii

    Warsaw, POL, 02-507

  • ZPZOZ w Otwocku Szpital Miejski

    Warsaw, POL, 05-400

Other trials in Poland

United Kingdom12 sites

  • Barnsley Hospital

    Barnsley, GBR, S75 2EP

  • Kingthorne Group Practice

    Doncaster, GBR, DN3 2LX

  • Manny Cussins Centre

    Leeds, GBR, LS9 7TF

  • Royal liverpool University Hospital

    Liverpool, GBR, L7 8XP

  • Clinical Research Centre The Royal London Hospital

    London, GBR, E1 2AT

  • Medinova Research Mount Vernon Hospital

    Middlesex, GBR, HA6 2RN

  • Edith Cavel Hospital Diabetes Centre

    Peterborough, GBR, PE3 9GZ

  • Northern General Hospital

    Sheffield, GBR, S5 7AU

  • Woolpit Medical Practice

    Suffolk, GBR, IP30 9QU

  • West Suffolk Hospital

    Suffolk, GBR, IP33 2QZ

  • Birmingham Heartland Hospital

    West Midlands, GBR, B9 5SS

  • Bradford Hospital Dept of Diabetes & Endocrinology

    West Yorkshire, GBR, BD9 6RJ

Other trials in United Kingdom

Canada10 sites

  • Finchlea Medical Group

    Brampton, Ontario, L6T 3J1

  • Courtice Health Centre

    Courtice, Ontario, Ontario, L1E 3C3

  • Parkwood Hospital

    London, Ontario, N6C 5J1

  • Quest Clinical Trials

    Markham, Ontario, L6B 1A1

  • Sarnia Institute of Clinical Research

    Sarnia, Ontario, N7T 4X3

  • The London Road Diagnostic Clinic and Medical Centre

    Sarnia, Ontario, N7T 4X3

  • Lifestyle Metabolism Center

    Thornhill, Ontario, L4J 8L7

  • Albany Medical Center

    Toronto, Ontario, M4K 1N5

  • Lifestyle Metabolism Center (600-118 Eglinton Ave W)

    Toronto, Ontario, M4R 2G4

  • Manna Research

    Toronto, Ontario, M9W 4L6

Other trials in Canada

Czechia7 sites

  • Diabetologicka ambulance

    Litoměřice, CZE, 41201

  • Surgery of Diabetology

    Mělník, CZE, 276 01

  • Diabetologicka a interni ambulance

    Ostrava, CZE, 70200

  • Internal Clinic

    Ostrava - Poruba, CZE, 708 52

  • Diabetologicka a interni ambulance

    Ostrava-Kunčice, CZE, 70702

  • Surgery of Diabetology Petrovice

    Prague, CZE, 109 00

  • FN Motol Interni Klinika

    Prague, CZE, 150 06

Other trials in Czechia

Spain7 sites

  • Fundacio Sarda Farriol

    Barcelona, ESP, 08017

  • Hospital Clinic I Provincial

    Barcelona, 08036

  • Fundacion Jimenez Diaz Servicio Endocrinologia y Nutricion

    Madrid, ESP, 28040

  • Hospital 12 de Octubre Consultas Extremas - Endocrinologia

    Madrid, ESP, 28041

  • Hospital Universitario de la Paz

    Madrid, ESP, 28046

  • Study site

    Seville, ESP, 41009

  • Hospital Univ Virgen del Rocío Scio Endocrinología Centro de Diagnosticos Pl Baja

    Seville, ESP, 41013

Other trials in Spain

About this study

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.

Pulmonary Safety in Diabetics with T/I

Being tested
Technosphere® Insulin Inhalation Powder, Usual Care
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Technosphere® Insulin Inhalation PowderDrug

    Inhalation, 15U/30U

  • Usual CareDrug

    Subjects will receive antidiabetes treatment at the discretion of their physicians

Study groups in NCT00308737
Study groupRoleWhat they receive
TI Inhalation PowderExperimentalTechnosphere® Insulin Inhalation Powder
Receives: Drug: Technosphere® Insulin Inhalation Powder
Usual careOtherUsual care
Receives: Drug: Usual Care
Non-diabetesNo interventionSubjects without abnormalities in glucose control (Note: Hypoglycemia and HbA1c were not reported for this group)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline to Month 24

  2. 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

    Measured: Baseline to Month 24

Secondary outcomes (10)

  1. Change From Baseline to Last Measurement in FEV1 for TI vs Usual Care

    Change from Baseline to last measurement(Month 24) in FEV1

    Measured: Baseline to Month 24

  2. Change From Baseline to Month 24 in Forced Vital Capacity (FVC) by MMRM

    Change from Baseline to Month 24 in FVC by MMRM

    Measured: Baseline to Month 24

  3. Change From Baseline to Month 24 in Total Lung Capacity (TLC) by MMRM

    Change from baseline to Month 24 in TLC by MMRM

    Measured: Baseline to Month 24

  4. Change From Baseline to Month 24 in Hemoglobin Corrected DLco by MMRM

    Change from baseline to Month 24 in hemoglobin-corrected DLco by MMRM

    Measured: Baseline to Month 24

  5. Forced Vital Capacity (FVC) Decrease of ≥ 15% From Baseline Value at Last Measurement

    FVC Decrease of ≥15% from Baseline Value at Last Measurement

    Measured: Baseline to Month 24

  6. Total Lung Capacity (TLC) Decrease of ≥ 15% From Baseline Value at Last Measurement

    TLC Decrease of ≥ 15% from Baseline Value at Last Measurement

    Measured: Baseline to Month 24

  7. 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

    Measured: Baseline to Month 24

  8. 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

    Measured: Baseline to Month 24

  9. Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Last Measurement for TI vs Usual Care

    Change from baseline in HbA1c at last measurement

    Measured: Baseline to Month 24

  10. Change in Weight From Baseline at Month 24

    Change from baseline in weight at Month 24

    Measured: Baseline to Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2006 (estimated)
  2. Study startJun 2005
  3. Primary completionSep 2008
  4. Study completionOct 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,053 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00308737
Sponsor's protocol ID
MKC-TI-030
Status last verified
Oct 2014
First submitted
28 Mar 2006
Last updated
16 Oct 2014

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Technosphere® Insulin Inhalation Powder in people with Diabetes, Type 1 and Diabetes, Type 2, run by Mannkind Corporation at 176 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 176 sites in United States, Russia, Ukraine, Poland, United Kingdom and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Month 24 in Forced Expiratory Volume in 1 Second (FEV1) by MMRM for TI vs Usual Care (time frame: Baseline to Month 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00308737.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in