Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes

October 9, 2014 updated by: Mannkind Corporation

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

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

589

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina, C1117ABH
        • Centro Endocrinologic Tiempo
      • Buenos Aires, Argentina, C1181ACH
        • Hospital Italiano de Buenos Aires
      • Buenos Aires, Argentina, C1405CWB
        • Hospital Durand /Buenos Aires
      • Buenos Aires, Argentina, C1406FWY
        • Hospital Gral De Agudos Dr. Teodoro Alvarez
      • Buenos Aires, Argentina, C1425AGC
        • Cons Asoc de Endocrinologia
      • Buenos Aires, Argentina, C1426ABP
        • Centro Medico Dra de Salvo
      • Buenos Aires, Argentina
        • CIMEL
    • Buenos Aires
      • Avellaneda, Buenos Aires, Argentina, B1870ARG
        • Hospital Interzonal de Agudos Pedro Fiorito
      • Maringa Parana, Brazil, 87020-900
        • Universidade Estabual de Maringa
      • Mogi das Cruzes, Brazil, 08780-090
        • Nucleo de Medicina Integrada
      • Rio de Janeiro, Brazil, 20211-340
        • Instituto Estadual De Diabetes e Endocrinologia Luis Capriglione
      • Rio de Janeiro, Brazil, 22271-100
        • CCBR Brasil Centro de Analises e Pesquisas Clínicas LTDA
      • Santos, Brazil, 11045-904
        • Hospital Guilherme Alvaro
      • Sao Paulo, Brazil, 01244-030
        • CPClin-Centro de Pesquisas Clinicas
      • Sao Paulo, Brazil, 04020-041
        • Centro de Diabetes/UNIFESP-EPM
      • Sao Paulo, Brazil, 05302-001
        • Blumenau Servicos Medicos S/C Ltda
      • Sao Paulo, Brazil, 05437-010
        • Instituto de Pesquisa Clinica e Medicina Avancada
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Hospital Sao Lucas da PUCRS
    • Ontario
      • Oakville, Ontario, Canada, L6H 3P1
        • Lifestyle Metabolism Center
      • Thornhill, Ontario, Canada, L4J 8L7
        • Lifestyle Metabolism Center
      • Toronto, Ontario, Canada, M4R 2G4
        • Lifestyle Metabolism Center
      • Windsor, Ontario, Canada, N8X 3V6
        • Windsor Professional Research
      • Santiago, Chile, 1196
        • Hospital San José
      • Santiago, Chile
        • Hospital Clinico Pontificia Universidad (009)Catolica de Chile
      • Santiago, Chile
        • Hospital Padre Alberto Hurtado
      • Santiago, Chile
        • Hospital San Borja ArriaranUniversidad de Chile
      • Santiago, Chile
        • Instituto de Informacion de Tramiento y Educacion en Salud
    • Region Metropolitana
      • Santiago, Region Metropolitana, Chile
        • Hospital del Salvador
      • Garza Garcia, Mexico, 66260
        • Hospital Santa Engracia-CIMA
      • Mexico City, Mexico, 01120
        • Centro de Estudios en Diabetes
      • Mexico City, Mexico, 06726
        • Hospital General de Mexico Servicio EndocrinologiaJefe Del Servicio
      • Monterrey, Mexico, 64000
        • Hospital OCA-MIRC (009)
    • Durango
      • Mexico City, Durango, Mexico, 06700
        • Instituto Mexicano de Investigacion
      • Bialystok, Poland, 15-950
        • Oddzial Chorob Wewnetrznych (009 Endokrynologii I Diabetologii Szpitala Wojewodzkiego
      • Lodz, Poland, 90-153
        • Oddzial Kliniczny Diabetologii (009) Kliniczny nr 1 im Norberta Barlickiego Uniwersytety Meycznego
      • Warszawa, Poland, 01-911
        • NZOZ Diabetologiczna Poradnia Specjalistyczna
    • POL
      • Bialystok, POL, Poland, 15-435
        • NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny
      • Krakow, POL, Poland, 31 501
        • Katedra I Klinika Chorob Metabolicznych Collegium Medicum Uniwersytety Jagiellonskiego
      • Lodz, POL, Poland, 93-338
        • Instytut Centrum Zdrowia (009) Matki Polki
      • Pruszkow, POL, Poland, 05 800
        • Szpital Kolejowy im Dr w Roeflera(009) Oddzial Gastorenterologii
      • Moscow, Russian Federation, 119 048
        • City Clinical Hospital # 61
      • Moscow, Russian Federation, 121069
        • Russian Scientific Center of Restoration Medicine & Balneology
    • RUS
      • Kemerovo, RUS, Russian Federation, 650061
        • NHI Kemerovo Regional Clinical Hospital
      • Moscow, RUS, Russian Federation, 105229
        • NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense
      • Moscow, RUS, Russian Federation, 111399
        • NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70
      • Moscow, RUS, Russian Federation, 115280
        • Moscow City Clinical Hospital # 13
      • Moscow, RUS, Russian Federation, 119435
        • SEI HPE Moscow Medical Academy IM Sechenov of Roszdrav Clinic of Endocrinology
      • Moscow, RUS, Russian Federation, 125299
        • SI Internal Affairs of Moscow- Clinical Hospital
      • Moscow, RUS, Russian Federation, 125315
        • RAAMS Endocrinology and Diabetology Department
      • Moscow, RUS, Russian Federation, 127644
        • SIH of Moscow City Clinical Hopsital #81Endocrinology and Diabetology
      • St Petersburg, RUS, Russian Federation, 193012
        • St Petersburg NHI City Polytclinic #77 City Diabetological Center #4
      • St Petersburg, RUS, Russian Federation, 194291
        • Central Medical Sanitary Unit #122
      • St Petersburg, RUS, Russian Federation, 197022
        • Pavlov State Medical Univ of St Petersburg
      • St. Petersburg, RUS, Russian Federation, 194354
        • St Petersburg NHI Municipal Multi-Speciality Hospital # 2
      • Yaroslavl, RUS, Russian Federation, 150003
        • MHI Clinical Hospital for Emergency Care na NV Soloviev
      • Yaroslavl, RUS, Russian Federation, 150023
        • MCHI Medical Sanitary Unit of Novo-Yaroslavsky Oil Refining Plant
      • Yaroslavl, RUS, Russian Federation, 150062
        • NHI Yaroslavl Regional Clinical Hospital
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal
      • Sevilla, Spain, 41013
        • Complejo Hospitalario Virgen del Rocío
      • Sevilla, Spain, 41071
        • Hospital Virgen Macarena (policlinico) 2ª planta Servicio de Endocrinologia y Nutricion
    • Andalucia
      • Sevilla, Andalucia, Spain, 41014
        • Complejo Hospitalario Nuestra Senora de Valme
      • London, United Kingdom, SE1 9RT
        • Guy's & St Thomas Hospital
      • Peterborough, United Kingdom, PE7 3JL
        • Yaxley Group Practice
    • Herts
      • Letchworth, Herts, United Kingdom, SG6 4UB
        • Birchwood Surgery
      • Stevenage, Herts, United Kingdom, SG1 4AB
        • Lister Hospital
    • West Bromwich
      • Lyndon, West Bromwich, United Kingdom, B71 4HJ
        • Sandwell General Hospital
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Coastal Clinical Research Inc
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Radiant Research (Phoenix)
    • California
      • Chula Vista, California, United States, 91911
        • International Clinical Research Network
      • Foothill Ranch, California, United States, 92610
        • Family Medical Center
      • Huntington Beach, California, United States, 92648
        • Diabetes/Lipid Management and Research Center
      • Inglewood, California, United States, 90301
        • South Bay Clinical Research
      • San Diego, California, United States, 92123
        • Radiant Research
      • Santa Monica, California, United States, 90404
        • Coastal Biomedical Research Inc
      • Tustin, California, United States, 92780
        • Diabetes Research Center
    • Florida
      • Miami, Florida, United States, 33156
        • International Research Associates LLC
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Laureate Clinical Research Group
      • Dunwoody, Georgia, United States, 30338
        • Atlanta Pharmaceutical Research Center
      • Lawrenceville, Georgia, United States, 30045
        • North Atlanta Endocrinology & Diabetes PC
      • Roswell, Georgia, United States, 30076
        • Endocrine Research Solutions, Inc.
    • Illinois
      • Chicago, Illinois, United States, 60612
        • John H Stoger Jr Hospital of Cook County
      • Skokie, Illinois, United States, 60076
        • Clintell Inc
    • Louisiana
      • Metairie, Louisiana, United States, 70002
        • Medical Research of Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Oschner Clinic Foundation
    • Maryland
      • Towson, Maryland, United States, 21204
        • James A Dicke MDPA
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center
      • Livonia, Michigan, United States, 48152
        • Michigan Institute of Medicine
      • St Clair Shores, Michigan, United States, 48081
        • KMED Research
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Radiant Research Inc (Minneapolis)
      • Minneapolis, Minnesota, United States, 55416
        • International Diabetes Center
      • Minneapolis, Minnesota, United States, 55455
        • Center for Urologic Clinical Trials University of Minnesota
    • Missouri
      • Florissant, Missouri, United States, 63031
        • HealthCare Research
      • St Louis, Missouri, United States, 63117
        • MedEx Healthcare Research Inc(009)
      • St Peters, Missouri, United States, 63376
        • Amin Radparvar's Private Practice
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic Research Division
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton Diabetes Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico HCS
    • New York
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
      • New Hyde Park, New York, United States, 11042
        • North Shore Diabetes and Endocrine Associates
      • Staten Island, New York, United States, 10301
        • University of Physicians Group Endocrine Division
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Endocrine Research - Physician's East PA
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Dayton, Ohio, United States, 45439
        • Providence Health Partners - Center of Clinical Research
    • Oregon
      • Portland, Oregon, United States, 97210
        • Portland Diabetes & Endocrinology Center
      • Portland, Oregon, United States, 97232
        • Legacy Clinical Research
      • Portland, Oregon, United States, 97239
        • Covance CRU Inc.
    • Pennsylvania
      • Bensalem, Pennsylvania, United States, 19020
        • Pennsylvania Research Institute
    • South Carolina
      • Williamston, South Carolina, United States, 29697
        • Southeastern Research Associates Inc
    • Tennessee
      • Bartlett, Tennessee, United States, 38133
        • AM Diabetes And Endocrinology Center
      • Memphis, Tennessee, United States, 38119
        • The Endocrine Clinic
    • Texas
      • Arlington, Texas, United States, 76014
        • Israel Hartman MD
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Dallas, Texas, United States, 75231
        • Radiant Research Dallas-North
      • Dallas, Texas, United States, 75246
        • Baylor Endocrine Center
      • Dallas, Texas, United States, 75230
        • Dallas Diabetes & Endocrine Center
      • Friendswood, Texas, United States, 77546
        • Spuhler Medical Associates
      • San Antonio, Texas, United States, 78229
        • Diabetes & Glandular Disease Research Assoc PA
      • San Antonio, Texas, United States, 78205
        • Quality Assurance Research Center (900)
      • San Antonio, Texas, United States, 78229
        • Sam Clinical Research Center
      • Seguin, Texas, United States, 78155
        • Edward Bali MD PA
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Radiant Research Salt Lake City
      • Salt Lake City, Utah, United States, 84107
        • Salt Lake Research
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
        • Sentara Medical Group
    • Washington
      • Federal Way, Washington, United States, 98003
        • Larry D Stonesifer MD Inc PS
      • Tacoma, Washington, United States, 98405
        • Cedar Research
      • Tacoma, Washington, United States, 98405
        • Liberty Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Technosphere Insulin
Inhalation, 15U/30U
Active Comparator: 2
Rapid-acting analogue insulin plus basal insulin glargine
sc injectable insulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare the Mean Change From Baseline to Week 52 in HbA1c
Time Frame: Baseline to Week 52
Baseline to Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Weight to Week 52
Time Frame: Baseline to Week 52
Change from baseline in weight at Week 52
Baseline to Week 52
Change From Baseline in Fasting Plasma Glucose to Week 52
Time Frame: Baseline to Week 52
Change from baseline in fasting plasma glucose at Week 52
Baseline to Week 52
Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0%
Time Frame: Baseline to Week 52
Number of subjects achieving week 52 HbA1c levels less than or equal to 7.0%
Baseline to Week 52
Incidence of Total Hypoglycemia
Time Frame: Baseline to Week 52
Defined as hypoglycemic symptoms that are relieved with carbohydrate intake or blood glucose measurement <= 63 mg/dL, regardless of symptoms.
Baseline to Week 52
Incidence of Severe Hypoglycemia
Time Frame: Baseline to Week 52

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.
Baseline to Week 52
Total Hypoglycemia Event Rate
Time Frame: Baseline to Week 52
Number of Hypoglycemic Events/Total Subject Exposure Time (in months)
Baseline to Week 52
Severe Hypoglycemia Event Rate
Time Frame: Baseline to Week 52
Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)
Baseline to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

March 27, 2006

First Submitted That Met QC Criteria

March 27, 2006

First Posted (Estimate)

March 29, 2006

Study Record Updates

Last Update Posted (Estimate)

October 16, 2014

Last Update Submitted That Met QC Criteria

October 9, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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