Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma

May 3, 2012 updated by: Mannkind Corporation

A Phase 3, 12-month Treatment, Multicenter, Randomized, Open-Label, Parallel Group Clinical Trial Comparing Prandial Subcutaneous Insulin With Prandial Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma

The clinical trial is designed to evaluate the safety of inhaled Technosphere/Insulin compared with non-inhaled anti-diabetic therapies in subjects with type 1 or type 2 diabetes mellitus and concurrent asthma.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

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

  • Argentina
      • Buenos Aires, Argentina, 1704
        • DIM (Clinica Privada)
      • La Plata, Argentina
        • Ins De Inv Cardiovascular La Plata
  • Brazil
      • Porto Alegre, Brazil, 90035-070
        • Irmandade da Santa Casa de Misericordia de Porto Alegre
      • Porto Alegre, Brazil, 90610-000
        • Hospital Sao Lucas - PUCRS (Fritscher)
      • Porto Alegre, Brazil, 91350-200
        • Hospital Nossa Senhora da Conceicao
      • Rio de Janeiro, Brazil, 22271-100
        • CCBR Brasil Centro de Analises e Pesquisas Clínicas LTDA
      • Sao Paulo, Brazil, 01244-030
        • CPClin-Centro de Pesquisas Clinicas
      • Sao Paulo, Brazil, 01323-001
        • Clinica de Endocrinologia
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre
  • Canada
    • Ontario
      • Brampton, Ontario, Canada, L6T 3J1
        • Finchlea Medical Group
      • Courtice, Ontario, Canada, L1E 3C3
        • Courtice Health Centre
      • London, Ontario, Canada, N6C 5J1
        • Parkwood Hospital
      • Sarnia, Ontario, Canada, N7T 4X3
        • The London Road Diagnostic Clinic and Medical Centre
      • Toronto, Ontario, Canada, M4K 1N5
        • Albany Medical Center
      • Windsor, Ontario, Canada, N8X 3V6
        • Windsor Professional Research
  • Czech Republic
      • Ostrava, Czech Republic, 70900
        • InternÃ- a diabetologická Outpatient
      • Ostrava, Czech Republic, 728 80
        • I InternÃ- klinika
    • CZE
      • Melnik, CZE, Czech Republic, 276 01
        • Surgery of Diabetology
      • Praha 5, CZE, Czech Republic, 15031
        • Interni oddeleni nemocnice Na Homolce
      • Slany, CZE, Czech Republic, 274 01
        • Diabetologicka Outpatient Surgery of Diabetology
  • Mexico
      • Delegacion Cuauhtemoc, Mexico, 6700
        • Nuevo Sanatorio Durango
      • Huixquilucan, Mexico, 52760
        • Hospital Angeles de las Lomas
    • DF
      • Mexico City, DF, Mexico, 06726
        • Hospital Angeles Mocel
    • MX
      • Mexico City, MX, Mexico, 06700
        • Mexican Institute of Clinical Research
  • Poland
      • Lodz, Poland, 90-153
        • Oddzial Kliniczny Diabetologii (009) Kliniczny nr 1 im Norberta Barlickiego Uniwersytety Meycznego
    • POL
      • Bialystock, POL, Poland, 15-276
        • Klinika Endocrinologii Diabetologii I
      • Bialystok, POL, Poland, 15-435
        • NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny
      • Krakow, POL, Poland, 30 510
        • Dzial Badan Klinicznych Malopoiskie
      • Krakow, POL, Poland, 31121
        • III Oddzial Chorob Wewnetrznych Szpital
    • Zgierz
      • Lodz, Zgierz, Poland, 95-100
        • Oddzial Chorob Wewnetrznych Wojewodzki
  • Russian Federation
      • Moscow, Russian Federation, 119 048
        • City Clinical Hospital # 61
      • Moscow, Russian Federation, 121069
        • Russian Scientific Center of Restoration Medicine & Balneology
      • Moscow, Russian Federation, 105077
        • Federal State Institution Pulmonology Research Institute of Federal Agency of HC&SD
      • Moscow, Russian Federation, 117 198
        • City Clinical Hospital #64 Center of Applied Clinical Paharmacology Friendship University
      • Moscow, Russian Federation, 117 593
        • Central Clinical Hospital of Russian Science Academy
      • St Petersburg, Russian Federation
        • St Petersburg Medical Academy (Ilkovich)
    • 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
      • Moscow, RUS, Russian Federation, 109240
        • Moscow State Medico-Stomatological University City Hospital # 23
      • Smolensk, RUS, Russian Federation, 214018
        • Smolensk Medical Academy Smolensk Regional Clinical Hospital
      • St Petersburg, RUS, Russian Federation, 194291
        • Central Medical Sanitary Unit #122
      • St. Petersburg, RUS, Russian Federation, 194354
        • City Hospital # 2 Endocrinology Department
      • Yaroslavl, RUS, Russian Federation, 150003
        • Yaroslavl Municipal Health Care Institution Clinical Hospital for Emergency Care na NV Soloviev
  • Spain
      • Barcelona, Spain, 30108025
        • Hospital 2 de Maig
  • Ukraine
    • UKR
      • Donetsk, UKR, Ukraine, 83003
        • Donetsk State Medical University
      • Donetsk, UKR, Ukraine, 83009
        • Donetsk State Medical University
      • Donetsk, UKR, Ukraine, 83114
        • Railway Clinical Hospital on Donetsk Station
      • Kiev, UKR, Ukraine, 04050
        • Chair Family Med of National Med University
      • Kiev, UKR, Ukraine, 04114
        • Institute of Endocrinology and Metabolism
  • United Kingdom
      • Cambridge, United Kingdom, CB2 2QQ
        • Addenbrooke's Hospital Department of Medicine
    • GBR
      • London, GBR, United Kingdom, E1 2AT
        • Clinical Research Centre The Royal London Hospital
      • Sheffield, GBR, United Kingdom, S5 7AU
        • Northern General Hospital
      • West Midlands, GBR, United Kingdom, B9 5SS
        • Birmingham Heartland Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Arizona Research Center
      • Phoenix, Arizona, United States, 85029
        • Northwest Medical Center
      • Tempe, Arizona, United States, 85282
        • Premiere Pharmaceutical Research LLC
      • Tucson, Arizona, United States, 85712
        • Canyon Internal Medicine
    • California
      • Buena Park, California, United States, 90620
        • Associated Pharmaceutical Research Center Inc
      • Foothill Ranch, California, United States, 92610
        • Family Medical Center
      • Long Beach, California, United States, 90806
        • Health Care Partners Medical Group
      • Long Beach, California, United States, 90807
        • Golden Pine Clinical Research
      • Los Angeles, California, United States, 90033
        • Keck USC School of Medicine
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Pinaccle Trials Inc (SMO)
      • Atlanta, Georgia, United States, 30342
        • Executive Health and Research Associates Inc
      • Dunwoody, Georgia, United States, 30338
        • Atlanta Pharmaceutical Research Center
      • Roswell, Georgia, United States, 30076
        • Southeastern Endocrine & Diabetes
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Cedar-Crosse Research Center
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Franklin Square Hospital
    • Missouri
      • Florissant, Missouri, United States, 63031
        • HealthCare Research
      • St Louis, Missouri, United States, 63117
        • MedEx Healthcare Research Inc(009)
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic Research Division
    • New Jersey
      • Hillsborough, New Jersey, United States, 08844
        • Your Doctors Care
      • Trenton, New Jersey, United States, 08618
        • Hopewell Valley Family Medicine PA
    • New York
      • New York, New York, United States, 10021
        • Eastside Comprehensive Medical Center
    • North Carolina
      • Concord, North Carolina, United States, 28025
        • Carolinas Research
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Dept of Endocrinology
    • Texas
      • San Antonio, Texas, United States, 78229
        • Diabetes & Glandular Disease Research Assoc PA
      • Waco, Texas, United States, 76707
        • McLennan County Medical Education and Research Foundation

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A clinical diagnosis of Step 1 to 3 asthma as per the NAEPP guidelines
  • Clinical diagnosis of Type 1 or Type 2 diabetes mellitus for at least 1 year
  • Current stable anti-diabetic regimen (insulin alone or in combination with oral anti-hyperglycemic agents)
  • Subjects must exhibit <30% variability in PEF measurements during the 2 week run in period.
  • Subjects must not meet any criteria for exacerbations of asthma during the 2 week run in period
  • Body mass index (BMI) < 40kg/m2
  • HbA1c >6.0% to <11.5%

Exclusion Criteria:

  • Severe complications of diabetes in the opinion of the investigator
  • Seizure disorder
  • Significant cardiovascular dysfunction and/or history within 3 months of screening
  • Hypertension with systolic blood pressure of !80 mm Hg and/or diastolic blood pressure >110 mm HG at screening despite pharmacologic therapy.
  • Clinical nephrotic syndrome or renal dysfunction or disease
  • Total daily insulin requirement of >1.4 U/kg body weight
  • Clinical diagnosis of Step 4 asthma
  • Use of >6 puffs/day of fast acting bronchodilator
  • Currently using an insulin delivery pump
  • Use of Pramlintide acetate or any incretins must be discontinued 8 weeks prior to screening
  • Two or more severe hypoglycemic episodes within the past 6 months.
  • Any hospitalization or emergency room visit due to poor diabetic control with 6 months of screening.
  • Current use of systemic steroids
  • Subjects who currently smoke tobacco or who have smoked within the past 6 months
  • Urine cotinine test of > 100ng/ml
  • Current drug or alcohol abuse
  • Clinically significant abnormalities on screening laboratory evaluation
  • Cancer within the past 5 years or any history of lung neoplasms
  • History of active and/or cirrhotic hepatic disease and/or abnormal liver enzymes.
  • Active infection or history of severe infection with 30 days of screening.
  • Anemia
  • History of anaphylaxis and/or angioneurotic edema
  • Diagnosis of chronic obstructive pulmonary disease (COPE)
  • Previous exposure to any inhaled insulin product

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary safety outcome will be measurements of post bronchodilator FEV1 throughout the treatment period

Collaborators and Investigators

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

Sponsor

Mannkind Corporation

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

June 1, 2006

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

June 1, 2006

First Submitted That Met QC Criteria

June 1, 2006

First Posted (Estimate)

June 2, 2006

Study Record Updates

Last Update Posted (Estimate)

May 4, 2012

Last Update Submitted That Met QC Criteria

May 3, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MKC-TI-105

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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