An Open-label, Multi-center, International, Three-year, Safety and Tolerability 'Follow on' Trial
NCT ID: NCT00754624
Last Updated: 2014-10-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
229 participants
INTERVENTIONAL
2004-05-31
2008-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluate Safety of Technosphere® Insulin (TI) in Diabetic Subjects With Moderate Obstructive Pulmonary Disease
NCT00642616
Comparison of Technosphere® Insulin Versus Technosphere Powder (Placebo) in Insulin-Naive Subjects With Type 2 Diabetes Mellitus
NCT01451398
Study of the Efficacy and Safety of Inhaled Technosphere Insulin in Patients With Type 2 Diabetes
NCT00511602
18-Week, Randomized, Double-blind, Placebo Controlled, Forced Titration Study of Patients With Type 2 Diabetes
NCT00511732
Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma
NCT00332826
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TI Inhalation Powder
Technosphere® Insulin Inhalation Powder
Technosphere® Insulin Inhalation Powder and MedTone™ Inhaler
Inhalation starting at 15, 30, or 60U doses and can be titrated up or down by 15U to a minimum of 15U or a maximum of 90U
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Technosphere® Insulin Inhalation Powder and MedTone™ Inhaler
Inhalation starting at 15, 30, or 60U doses and can be titrated up or down by 15U to a minimum of 15U or a maximum of 90U
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subjects must be able to attend all scheduled visits and, in the opinion of the Investigator, be able to complete this safety trial
* Subjects must be able to understand English or have access to validated primary language trial documents
* Written informed consent
Exclusion Criteria
* Smokers (subjects are expected to remain non-smokers throughout their participation in this trial)
* Known hypersensitivity to the trial drug or to drugs of similar chemical structures
* Anemia (hemoglobin level \< 11 g/dL for females or \< 12 g/dL for males)
* Evidence of moderate or greater ketones in urine
* Women of childbearing potential practicing inadequate birth control. (Adequate birth control is defined as using oral contraceptives, condoms or diaphragms with spermicide, intrauterine devices, Depo-Provera, contraceptive patches or surgical sterilization)
* Women who are pregnant
* Clinically significant adverse events that remain unresolved from the previous trial and/or clinically significant abnormal laboratory values which are determined by the Investigator or the MKC Medical Monitor to be unsafe or confounding to continued participation
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mannkind Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anders Boss, MD
Role: STUDY_DIRECTOR
Mannkind Corporation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dorothy L & James E Frank Diabetes Research Institute
San Mateo, California, United States
Sansum Medical Research Institute
Santa Barbara, California, United States
Alliance Medical Group of Greater Waterbury
Middlebury, Connecticut, United States
The Hospital of Central Connecticut
New Britain, Connecticut, United States
Soundview Research Associates
Norwalk, Connecticut, United States
University of Miami School of Medicine
Miami, Florida, United States
Oschner Clinic Foundation
New Orleans, Louisiana, United States
International Diabetes Center
Minneapolis, Minnesota, United States
Diabetes Care & Information Center of New York
Flushing, New York, United States
Diabetes Team Associated
New York, New York, United States
Endocrine Research - Physician's East PA
Greenville, North Carolina, United States
Your Diabetes Endocrine Nutrition Group
Mentor, Ohio, United States
Dallas Diabetes & Endocrine Center
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Texas Diabetes Institute
San Antonio, Texas, United States
Diabetes & Glandular Disease Research Assoc PA
San Antonio, Texas, United States
Diabetes Care Center
Seattle, Washington, United States
MBAL "Pleven"
Pleven, BGR, Bulgaria
SBALENG-Sofia Institute of Endocrinology
Sofia, BGR, Bulgaria
MBAL Alexandrovska Hospital
Sofia, BGR, Bulgaria
Military Medical Academy
Sofia, BGR, Bulgaria
Central Clinical Base
Sofia, BGR, Bulgaria
MBAL "Sweta Marina" - Varna
Varna, BGR, Bulgaria
II-nd MBAL
Sofia, Sofia, Bulgaria
Military Medical Academy
Sofia, , Bulgaria
Military Hospital in Brno
Brno, CZE, Czechia
Hospital of "Milosrdnych brain"
Brno, CZE, Czechia
University Hospital in Brno
Brno-Bohunice, CZE, Czechia
Surgery of Diabetology
Mělník, CZE, Czechia
University Hospital of 3rd Faculty
Prague, CZE, Czechia
Surgery of Diabetology Petrovice
Prague, CZE, Czechia
Diabetologicka oridnace
Prague, CZE, Czechia
General Hospital in Prague and 1st Faculty of Medicine of
Prague, CZE, Czechia
Institute for Clinical and Exp Medicine
Prague, CZE, Czechia
Surgery of Diabetology Stodulky
Prague, CZE, Czechia
University Hospital Na Bulovce
Prague, CZE, Czechia
Surgery of Diabetology Slany
Slaný, CZE, Czechia
Surgery of Diabetology Zastavka
Zastavka, Brno, CZE, Czechia
Surgery of Diabetology (Brno)
Brno, , Czechia
ikfe Berlin
Berlin, DEU, Germany
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MKC-TI-010
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.