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Type 1 DiabetesNCT00741429

A 2-Month Safety Follow-Up Trial

An observational study of Type 1 Diabetes and Type 2 Diabetes, run by Mannkind Corporation at 150 sites in 4 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

The main purpose of the trial is to evaluate pulmonary function in subjects who had completed any one of the 4 MKC parent trials (MKC-TI-009, MKC-TI-102, MKC-TI-103, or MKC-TI-030) for an additional 2-month safety follow-up. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Type 1 Diabetes, Type 2 Diabetes
What is being tested?
Technosphere Insulin Inhalation Powder and Comparator
How many people
649 participants
Where
150 sitesin 4 countries
Study dates
May 2007to Sep 2008
Phase
Observational
Are there results?
None posted in the registry

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
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population consists of eligible type 1 and type 2 diabetic subjects who have completed any of the 4 MKC parent trials (MKC-TI-103, MKC-TI-009, MKC-TI-102, MKC-TI-030).

Who may be able to join

  • Subjects who have completed any of the 4 MKC parent trials (MKC-TI-103, MKC-TI-009, MKC-TI-102, MKC-TI-030)
  • Urine cotinine test of less than or equal to 100 ng/mL
  • Written informed consent

Who cannot join

  • Subjects who started smoking during the 4 week follow-up phase of the parent trial
  • Subjects who began a new inhaled insulin regimen with an investigational drug during the 4 week follow-up phase of the parent trial and/or are participation in another clinical trial
  • Female subjects who are pregnant, lactating or planning on becoming pregnant
  • Subjects with a positive urine drug screening at Visit 1
  • Female subjects of child-bearing potential not practicing adequate birth control

Trial locations and contacts

150 sites in 4 countries.

150 sites in 4 countries

United States109 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

  • University of New Mexico HCS

    Albuquerque, New Mexico, 87131

  • Israel Hartman MD

    Arlington, Texas, 76014

  • Laureate Clinical Research Group

    Atlanta, Georgia, 30308

  • Executive Health and Research Associates Inc

    Atlanta, Georgia, 30342

  • MODEL Clinical Research

    Baltimore, Maryland, 21204

  • Health Trends Research LLC

    Baltimore, Maryland, 21209

  • Franklin Square Hospital

    Baltimore, Maryland, 21237

  • AM Diabetes and Endocrinology Center

    Bartlett, Tennessee, 38133

  • Deaconess Billings Clinic Research Center

    Billings, Montana, 59101

  • Montana Health Research Institute

    Billings, Montana, 59102

  • Parkway Medical Center

    Birmingham, Alabama, 35215

  • Pharmaceutical Research Organization

    Bountiful, Utah, 84010

  • Private Practice

    Burlingame, California, 94010

  • Radiant Research (Phoenix)

    Chandler, Arizona, 85225

  • Metrolina Medical Research

    Charlotte, North Carolina, 28209

  • Sensenbrenner Primary Care

    Charlotte, North Carolina, 28277

  • Cedar-Crosse Research Center

    Chicago, Illinois, 60607

  • 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

  • Rapid Medical Research Inc

    Cleveland, Ohio, 44122

  • Texas Familicare Clinical Research

    Colleyville, Texas, 76034

  • Collierville Medical Specialists

    Collierville, Tennessee, 38017

  • Rockdale Medical Research Associates

    Conyers, Georgia, 30094

  • Dallas Diabetes & Endocrine Center

    Dallas, Texas, 75230

  • North Texas Endocrine Center

    Dallas, Texas, 75231

  • Radiant Research Dallas-North

    Dallas, Texas, 75231

  • Baylor Endocrine Center

    Dallas, Texas, 75246

  • Galenos Research

    Dallas, Texas, 75251

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Providence Health Partners - Center of Clinical Research

    Dayton, Ohio, 45439

  • Private Practice

    Decatur, Georgia, 30035

  • Creekside Endocrine Associates

    Denver, Colorado, 80209

  • 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

  • Diabetes Care & Information Center of New York

    Flushing, New York, 11365

  • Family Medical Center

    Foothill Ranch, California, 92610

  • Saad Hijazi MD Inc

    Fresno, California, 93710

  • Saint Agnes Medical Center

    Fresno, California, 93720

  • Valley Research

    Fresno, California, 93720

  • Spuhler Medical Associates

    Friendswood, Texas, 77546

  • Digestive & Liver Disease Specialist A Medical Group Inc

    Garden Grove, California, 92840

  • Physician's East PA

    Greenville, North Carolina, 27834

  • Upstate Pharmaceutical Research

    Greenville, South Carolina, 29615

  • Your Doctors Care

    Hillsborough, New Jersey, 08844

  • Center for Diabetes & Endocrine Care

    Hollywood, Florida, 33021

  • Diabetes/Lipid Management and Research Center

    Huntington Beach, California, 92648

  • Wells Institute for Health Awareness

    Kettering, Ohio, 45429

  • North Atlanta Endocrinology & Diabetes PC

    Lawrenceville, Georgia, 30045

  • Interlink Research Institute

    Los Alamitos, California, 90720

  • Magna Center for Family Medicine

    Magna, Utah, 84044

  • Memphis Internal Medicine PLLC

    Memphis, Tennessee, 38119

  • Your Diabetes Endocrine Nutrition Group

    Mentor, Ohio, 44060

  • University of Miami Diabetes Research Institute

    Miami, Florida, 33136

  • International Research Associates LLC

    Miami, Florida, 33156

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Center for Urologic Clinical Trials University of Minnesota

    Minneapolis, Minnesota, 55455

  • Coastal Clinical Research Inc

    Mobile, Alabama, 36608

  • Bucks County Clinical Research

    Morrisville, Pennsylvania, 19067

  • North Shore Diabetes and Endocrine Associates

    New Hyde Park, New York, 11042

  • M.E.R.I.

    New York, New York, 10023

  • Clinical Research Associates of Tidewater

    Norfolk, Virginia, 23507

  • Creighton Diabetes Center

    Omaha, Nebraska, 68131

  • Southern California Endocrine Center

    Pasadena, California, 91105

  • Southwest Health Ltd Research Division

    Phoenix, Arizona, 85016

  • Northwest Medical Center

    Phoenix, Arizona, 85029

  • SMO: Pharmaceuticals C-Trials North Texas Medical Research

    Plano, Texas, 75093

  • Portland Diabetes & Endocrinology Center

    Portland, Oregon, 97210

  • Legacy Clinical Research

    Portland, Oregon, 97232

  • Covance CRU Inc.

    Portland, Oregon, 97239

  • Rainier Clinical Research Center Inc

    Renton, Washington, 98055

  • 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 Inc

    San Antonio, Texas, 78205

  • Clinical Trials of Texas Inc

    San Antonio, Texas, 78229

  • Covenant Clinic Research

    San Antonio, Texas, 78229

  • Diabetes & Glandular Disease Research Assoc PA

    San Antonio, Texas, 78229

  • SAM Clinical Research Center

    San Antonio, Texas, 78229

  • Dorothy L & James E Frank Diabetes Research Institute

    San Mateo, California, 94401

  • Sansum Medical Research Institute

    Santa Barbara, California, 93105

  • Coastal Biomedical Research Inc

    Santa Monica, California, 90404

  • Encompass Clinical Research

    Spring Valley, California, 91978

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Clayton Medical Research

    St Louis, Missouri, 63117

  • MedEx Healthcare Research Inc(009)

    St Louis, Missouri, 63117

  • Mercy Health Research

    St Louis, Missouri, 63141

  • Univeristy of Physicians Group Endocrine Division

    Staten Island, New York, 10301

  • Cedar Research

    Tacoma, Washington, 98405

  • Liberty Research Center

    Tacoma, Washington, 98405

  • Southeastern Research Associates Inc

    Taylors, South Carolina, 29687

  • Scott & White Hospital and Clinic

    Temple, Texas, 76508

  • James A Dicke MDPA

    Towson, Maryland, 21204

  • Hopewell Valley Medical Group

    Trenton, New Jersey, 08618

  • Canyon Clinical Research

    Tucson, Arizona, 85712

  • Arizona Research Associates

    Tuscon, Arizona, 85712

  • Diabetes Research Center

    Tustin, California, 92780

  • Sentara Medical Group

    Virginia Beach, Virginia, 23462

  • Umdnj-Som

    Voorhees Township, New Jersey, 08043

  • Chase Medical Research LLC

    Waterbury, Connecticut, 06708

  • Wenatchee Valley Medical Center Clinical Research Department

    Wenatchee, Washington, 98801

  • Granger Medical Clinic

    West Valley City, Utah, 84120

Other trials in United States

Russia29 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

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

    Moscow, RUS, 109240

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

    Moscow, RUS, 111399

  • Russian State Medical University City Hospital # 4

    Moscow, RUS, 113093

  • Moscow City Clinical Hospital # 13

    Moscow, RUS, 115280

  • SHI of Moscow City Clinical Hospital #13

    Moscow, RUS, 115280

  • NI Central Clinical Hospital of RAS

    Moscow, RUS, 117 593

  • Russian State Medical University Central Clinical Hospital Russian Science Academy

    Moscow, RUS, 117593

  • City Clinical Hospital # 61

    Moscow, RUS, 119048

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

    Moscow, RUS, 119435

  • Russian Scientific Center of Restoration Medicine & Balneology

    Moscow, RUS, 121069

  • SI Internal Affairs of Moscow- Clinical Hospital

    Moscow, RUS, 125299

  • RAAMS Endocrinology and Diabetology Department

    Moscow, RUS, 125315

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

    Moscow, RUS, 127644

  • Ryazan State Medical University na academician IP Pavlov

    Ryazan, RUS, 390026

  • 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

  • TUV Medico-Military Academy

    Saint Petersburg, RUS, 198013

  • 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

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

    Yaroslavl, RUS, 150023

  • NHI Yaroslavl Regional Clinical Hospital

    Yaroslavl, RUS, 150062

  • Yaroslavl Regional Clinical Hospital

    Yaroslavl, RUS, 150062

Other trials in Russia

Canada10 sites

  • Aggarwal and Associates Ltd

    Brampton, Ontario, L6T 3J1

  • Parkwood Hospital

    London, Ontario, N6C 5J1

  • Quest Clinical Trials

    Markham, Ontario, L6C 1Y9

  • Lifestyle Metabolism Center

    Oakville, Ontario, L6H 3P1

  • 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

  • Lifestyle Metabolism Center

    Toronto, Ontario, M4R 2G4

  • Trial Management Group Inc (Henein

    Toronto, Ontario, M4T 1N5

  • Manna Research

    Toronto, Ontario, M9W 4L6

Other trials in Canada

Brazil2 sites

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • CPClin-Centro de Pesquisas Clinicas

    São Paulo, São Paulo, 01244-030

Other trials in Brazil

About this study

Official title: A 2-Month Safety Follow-up Trial of Subjects From MannKind Protocols MKC-TI-009, MKC-TI-102, MKC-TI-103 and MKC-TI-030

The main purpose of the trial is to evaluate pulmonary function in subjects who had completed any one of the 4 MKC parent trials (MKC-TI-009, MKC-TI-102, MKC-TI-103, or MKC-TI-030) for an additional 2-month safety follow-up.

Read the detailed description

This was a 2-month safety follow-up study of subjects from MannKind protocols MKC-TI-009, MKC-TI-102, MKC-TI-103 and MKC-TI-030. No study medications were administered during this trial. The adverse event data included are for the combined Safety population irrespective of previous treatments in the parent trials.

Being tested
Technosphere Insulin Inhalation Powder, Comparator
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

    Subjects previously treated with Technosphere Insulin Inhalation Powder

  • ComparatorDrug

    Subjects previously treated with other anti-diabetic medications

Study groups in NCT00741429
Study groupRoleWhat they receive
Ex-TIEx-Technosphere® Insulin Inhalation Powder (subjects previously received TI Inhalation Powder)
Receives: Drug: Technosphere Insulin Inhalation Powder
Non Ex-TINon Ex-Technosphere® Insulin Inhalation Powder (subjects previously received another anti-diabetic medication)
Receives: Drug: Comparator

What is being measured

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

  1. Change in FEV1 (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126

    Measured: 9 to 27 months

Secondary outcomes (7)

  1. Change in FVC (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126

    Measured: 9 to 27 months

  2. Change in TLC (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126

    Measured: 9 to 27 months

  3. Change in Hemoglobin Corrected DLco (mL/min/mm Hg) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126

    Measured: 9 to 27 months

  4. Change in FEV1 (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126

    Measured: 3 Months

  5. Change in FVC (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126

    Measured: 3 Months

  6. Change in TLC (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126

    Measured: 3 Months

  7. Change in Hemoglobin Corrected DLco (mL/min/mmHg) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126

    Measured: 3 Months

Timeline

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

  1. First posted26 Aug 2008 (estimated)
  2. Study startMay 2007
  3. Primary completionSep 2008
  4. Study completionSep 2008

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
649 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00741429
Sponsor's protocol ID
MKC-TI-126
Status last verified
Dec 2014
First submitted
22 Aug 2008
Last updated
3 Dec 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Type 1 Diabetes and Type 2 Diabetes, run by Mannkind Corporation at 150 sites in 4 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 3 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 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 150 sites in United States, Russia, Canada, Brazil. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 in FEV1 (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126 (time frame: 9 to 27 months). 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 NCT00741429.

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 3 Dec 2014.

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