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Diabetes, Type IPhase 3NCT00308308

Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes

A Phase 3 study testing Technosphere Insulin and Active comparator in people with Diabetes, Type I, run by Mannkind Corporation at 129 sites in 10 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

To determine the safety and efficacy of inhaled insulin in the treatment of type 1 diabetes Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes, Type I
What is being tested?
Technosphere Insulin and Active comparator
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
589 participants
Where
129 sitesin 10 countries
Study dates
Feb 2006to Aug 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 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of type 1 diabetes for at least 1 year
  • Nonsmokers for prior 6 months
  • BMI less than or equal to 35kg/m2
  • HbA1c > or = 7% and < or = 11%
  • Serum creatinine < or = 1.8 mg/dL in female subjects and < or = 2.0 mg/dL in male subjects
  • FEV1 > or = 70% of predicted, DLco > or = 70% , TLC > or = 80% predicted
  • Maintenance of a treatment regimen of insulin less than or equal to 1.4 iu/kg/day
  • Urine cotinine < or = 100 ng/mL

Who cannot join

  • History of chronic obstructive pulmonary disease, asthma, any other clinically significant pulmonary disease confirmed by documented history, pulmonary function testing or radiologic findings
  • Evidence of severe complications of diabetes
  • Aminotransferase and/or alanine aminotransferase > than 3 times the upper limit of normal

Trial locations and contacts

129 sites in 10 countries.

129 sites in 10 countries

United States61 sites

  • University of New Mexico HCS

    Albuquerque, New Mexico, 87131

  • Israel Hartman MD

    Arlington, Texas, 76014

  • Laureate Clinical Research Group

    Atlanta, Georgia, 30308

  • AM Diabetes and Endocrinology Center

    Bartlett, Tennessee, 38133

  • Pennsylvania Research Institute

    Bensalem, Pennsylvania, 19020

  • Billings Clinic Research Division

    Billings, Montana, 59101

  • Radiant Research (Phoenix)

    Chandler, Arizona, 85225

  • John H Stoger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • International Clinical Research Network

    Chula Vista, California, 91911

  • Amin Radparvar's Private Practice

    City of Saint Peters, Missouri, 63376

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Dallas Diabetes & Endocrine Center

    Dallas, Texas, 75230

  • Radiant Research Dallas-North

    Dallas, Texas, 75231

  • Baylor Endocrine Center

    Dallas, Texas, 75246

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Providence Health Partners - Center of Clinical Research

    Dayton, Ohio, 45439

  • Wayne State University

    Detroit, Michigan, 48201

  • Atlanta Pharmaceutical Research Center

    Dunwoody, Georgia, 30338

  • Radiant Research Inc (Minneapolis)

    Edina, Minnesota, 55435

  • Larry D Stonesifer MD Inc PS

    Federal Way, Washington, 98003

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Healthcare Research

    Florissant, Missouri, 63031

  • Family Medical Center

    Foothill Ranch, California, 92610

  • Spuhler Medical Associates

    Friendswood, Texas, 77546

  • Endocrine Research - Physician's East PA

    Greenville, North Carolina, 27834

  • Diabetes/Lipid Management and Research Center

    Huntington Beach, California, 92648

  • South Bay Clinical Research

    Inglewood, California, 90301

  • North Atlanta Endocrinology & Diabetes PC

    Lawrenceville, Georgia, 30045

  • Michigan Institute of Medicine

    Livonia, Michigan, 48152

  • The Endocrine Clinic

    Memphis, Tennessee, 38119

  • Medical Research of Louisiana

    Metairie, Louisiana, 70002

  • International Research Associates LLC

    Miami, Florida, 33156

  • Winthrop University Hospital

    Mineola, New York, 11501

  • International Diabetes Center

    Minneapolis, Minnesota, 55416

  • Center for Urologic Clinical Trials University of Minnesota

    Minneapolis, Minnesota, 55455

  • Coastal Clinical Research Inc

    Mobile, Alabama, 36608

  • North Shore Diabetes and Endocrine Associates

    New Hyde Park, New York, 11042

  • Oschner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Creighton Diabetes Center

    Omaha, Nebraska, 68131

  • Portland Diabetes & Endocrinology Center

    Portland, Oregon, 97210

  • Legacy Clinical Research

    Portland, Oregon, 97232

  • Covance CRU Inc.

    Portland, Oregon, 97239

  • Endocrine Research Solutions, Inc.

    Roswell, Georgia, 30076

  • KMED Research

    Saint Clair Shores, Michigan, 48081

  • Radiant Research Salt Lake City

    Salt Lake City, Utah, 84107

  • Salt Lake Research

    Salt Lake City, Utah, 84107

  • Quality Assurance Research Center (900)

    San Antonio, Texas, 78205

  • Diabetes & Glandular Disease Research Assoc PA

    San Antonio, Texas, 78229

  • SAM Clinical Research Center

    San Antonio, Texas, 78229

  • Radiant Research

    San Diego, California, 92123

  • Coastal Biomedical Research Inc

    Santa Monica, California, 90404

  • Edward Bali MD PA

    Seguin, Texas, 78155

  • Clintell Inc

    Skokie, Illinois, 60076

  • MedEx Healthcare Research Inc(009)

    St Louis, Missouri, 63117

  • University of Physicians Group Endocrine Division

    Staten Island, New York, 10301

  • Cedar Research

    Tacoma, Washington, 98405

  • Liberty Research Center

    Tacoma, Washington, 98405

  • James A Dicke MDPA

    Towson, Maryland, 21204

  • Diabetes Research Center

    Tustin, California, 92780

  • Sentara Medical Group

    Virginia Beach, Virginia, 23462

  • Southeastern Research Associates Inc

    Williamston, South Carolina, 29697

Other trials in United States

Russia17 sites

  • 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

  • NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70

    Moscow, RUS, 111399

  • Moscow City Clinical Hospital # 13

    Moscow, RUS, 115280

  • SEI HPE Moscow Medical Academy IM Sechenov of Roszdrav Clinic of Endocrinology

    Moscow, RUS, 119435

  • SI Internal Affairs of Moscow- Clinical Hospital

    Moscow, RUS, 125299

  • RAAMS Endocrinology and Diabetology Department

    Moscow, RUS, 125315

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

    Moscow, RUS, 127644

  • City Clinical Hospital # 61

    Moscow, 119 048

  • Russian Scientific Center of Restoration Medicine & Balneology

    Moscow, 121069

  • 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

  • Pavlov State Medical Univ of St Petersburg

    Saint Petersburg, RUS, 197022

  • MHI Clinical Hospital for Emergency Care na NV Soloviev

    Yaroslavl, RUS, 150003

  • MCHI Medical Sanitary Unit of Novo-Yaroslavsky Oil Refining Plant

    Yaroslavl, RUS, 150023

  • NHI Yaroslavl Regional Clinical Hospital

    Yaroslavl, RUS, 150062

Other trials in Russia

Brazil11 sites

  • Universidade Estabual de Maringa

    Maringa Parana, 87020-900

  • Nucleo de Medicina Integrada

    Mogi das Cruzes, 08780-090

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital Sao Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Instituto Estadual De Diabetes e Endocrinologia Luis Capriglione

    Rio de Janeiro, 20211-340

  • Ccbr Brasil Centro de Analises e Pesquisas Clinicas Ltda

    Rio de Janeiro, 22271-100

  • Hospital Guilherme Alvaro

    Santos, 11045-904

  • CPClin-Centro de Pesquisas Clinicas

    São Paulo, São Paulo, 01244-030

  • Centro de Diabetes/UNIFESP-EPM

    São Paulo, 04020-041

  • Blumenau Servicos Medicos S/C Ltda

    São Paulo, 05302-001

  • Instituto de Pesquisa Clinica e Medicina Avancada

    São Paulo, 05437-010

Other trials in Brazil

Argentina8 sites

  • Hospital Interzonal de Agudos Pedro Fiorito

    Avellaneda, Buenos Aires, B1870ARG

  • Centro Endocrinologic Tiempo

    Buenos Aires, C1117ABH

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1181ACH

  • Hospital Durand /Buenos Aires

    Buenos Aires, C1405CWB

  • Hospital Gral De Agudos Dr. Teodoro Alvarez

    Buenos Aires, C1406FWY

  • Cons Asoc de Endocrinologia

    Buenos Aires, C1425AGC

  • Centro Medico Dra De Salvo

    Buenos Aires, C1426ABP

  • CIMeL

    Buenos Aires

Other trials in Argentina

Poland7 sites

  • NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny

    Bialystok, POL, 15-435

  • Oddzial Chorob Wewnetrznych (009 Endokrynologii I Diabetologii Szpitala Wojewodzkiego

    Bialystok, 15-950

  • Katedra I Klinika Chorob Metabolicznych Collegium Medicum Uniwersytety Jagiellonskiego

    Krakow, POL, 31 501

  • Instytut Centrum Zdrowia (009) Matki Polki

    Lodz, POL, 93-338

  • Oddzial Kliniczny Diabetologii (009) Kliniczny nr 1 im Norberta Barlickiego Uniwersytety Meycznego

    Lodz, 90-153

  • Szpital Kolejowy im Dr w Roeflera(009) Oddzial Gastorenterologii

    Pruszków, POL, 05 800

  • NZOZ Diabetologiczna Poradnia Specjalistyczna

    Warsaw, 01-911

Other trials in Poland

Chile6 sites

  • Hospital del Salvador

    Santiago, Santiago Metropolitan

  • Hospital San Jose

    Santiago, 1196

  • Hospital Clinico Pontificia Universidad (009)Catolica de Chile

    Santiago

  • Hospital Padre Alberto Hurtado

    Santiago

  • Hospital San Borja ArriaranUniversidad de Chile

    Santiago

  • Instituto de Informacion de Tramiento y Educacion en Salud

    Santiago

Other trials in Chile

Mexico5 sites

  • Hospital Santa Engracia-CIMA

    Garza García, 66260

  • Instituto Mexicano de Investigacion

    Mexico City, Durango, 06700

  • Centro de Estudios en Diabetes

    Mexico City, 01120

  • Hospital General de Mexico Servicio EndocrinologiaJefe Del Servicio

    Mexico City, 06726

  • Hospital OCA-MIRC (009)

    Monterrey, 64000

Other trials in Mexico

Spain5 sites

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Ramon y Cajal

    Madrid, 28034

  • Complejo Hospitalario Nuestra Senora de Valme

    Seville, Andalusia, 41014

  • Complejo Hospitalario Virgen del Rocio

    Seville, 41013

  • Hospital Virgen Macarena (policlinico) 2ª planta Servicio de Endocrinologia y Nutricion

    Seville, 41071

Other trials in Spain

United Kingdom5 sites

  • Birchwood Surgery

    Letchworth Garden City, Herts, SG6 4UB

  • Guy's & St Thomas Hospital

    London, SE1 9RT

  • Sandwell General Hospital

    Lyndon, West Bromwich, B71 4HJ

  • Yaxley Group Practice

    Peterborough, PE7 3JL

  • Lister Hospital

    Stevenage, Herts, SG1 4AB

Other trials in United Kingdom

Canada4 sites

  • Lifestyle Metabolism Center

    Oakville, Ontario, L6H 3P1

  • Lifestyle Metabolism Center

    Thornhill, Ontario, L4J 8L7

  • Lifestyle Metabolism Center

    Toronto, Ontario, M4R 2G4

  • Windsor Professional Research

    Windsor, Ontario, N8X 3V6

Other trials in Canada

About this study

Official title: A Prospective, Multi-Center, Open-Label, Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety in Subjects With Type 1 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Basal and Prandial Insulin Over a 52-Week Treatment Period and a 4-Week Follow Up

To determine the safety and efficacy of inhaled insulin in the treatment of type 1 diabetes

Being tested
Technosphere Insulin, Active comparator
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

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

  • Technosphere InsulinDrug

    Inhalation, 15U/30U

  • Active comparatorDrug

    sc injectable insulin

Study groups in NCT00308308
Study groupRoleWhat they receive
1ExperimentalTechnosphere Insulin
Receives: Drug: Technosphere Insulin
2Active comparatorRapid-acting analogue insulin plus basal insulin glargine
Receives: Drug: Active comparator

What is being measured

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

  1. Compare the Mean Change From Baseline to Week 52 in HbA1c

    Measured: Baseline to Week 52

Secondary outcomes (7)

  1. Change From Baseline in Weight to Week 52

    Change from baseline in weight at Week 52

    Measured: Baseline to Week 52

  2. Change From Baseline in Fasting Plasma Glucose to Week 52

    Change from baseline in fasting plasma glucose at Week 52

    Measured: Baseline to Week 52

  3. Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0%

    Number of subjects achieving week 52 HbA1c levels less than or equal to 7.0%

    Measured: Baseline to Week 52

  4. Incidence of Total Hypoglycemia

    Defined as hypoglycemic symptoms that are relieved with carbohydrate intake or blood glucose measurement <= 63 mg/dL, regardless of symptoms.

    Measured: Baseline to Week 52

  5. Incidence of Severe Hypoglycemia

    Severe hypoglycemia occurs when all 3 of the following occur simultaneously:

    • Subject requires the assistance of another person;
    • Subject exhibits at least 1 cognitive neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, seizure, loss of consciousness);
    • Measured BG is ≤ 49 mg/dL (2.7 mmol/L), or, in the absence of a BG measurement, clinical symptoms are reversed by oral carbohydrates, sc glucagon or intravenous glucose administration; OR,
    • Measured BG is ≤ 36 mg/dL (2.0 mmol/L) with or without symptoms.

    Measured: Baseline to Week 52

  6. Total Hypoglycemia Event Rate

    Number of Hypoglycemic Events/Total Subject Exposure Time (in months)

    Measured: Baseline to Week 52

  7. Severe Hypoglycemia Event Rate

    Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)

    Measured: Baseline to Week 52

Timeline

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

  1. First posted29 Mar 2006 (estimated)
  2. Study startFeb 2006
  3. Primary completionJul 2008
  4. Study completionAug 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
589 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00308308
Sponsor's protocol ID
MKC-TI-009
Status last verified
Oct 2014
First submitted
27 Mar 2006
Last updated
16 Oct 2014

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Technosphere Insulin and Active comparator in people with Diabetes, Type I, run by Mannkind Corporation at 129 sites in 10 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 8 inclusion and 3 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 129 sites in United States, Russia, Brazil, Argentina, Poland and 5 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?

Compare the Mean Change From Baseline to Week 52 in HbA1c (time frame: Baseline to Week 52). 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 NCT00308308.

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.

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