An Open-label, Multi-center, International, Three-year, Safety and Tolerability 'Follow on' Trial
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: Technosphere® Insulin Inhalation Powder and MedTone™ Inhaler
- Registration Number
- NCT00754624
- Lead Sponsor
- Mannkind Corporation
- Brief Summary
Safety Follow-Up Trial to PDC-INS-0008 and MKC-TI-005
- Detailed Description
This is an uncontrolled study without comparator. Subjects were followed up to 4 years on Technosphere Insulin. Of 229 subjects 199 were exposed for ≥12 mo, 175 for ≥ 24 mo, 60 for ≥ 36 mo, 31 for ≥ 42 mo, \& 2 for 48 mo.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 229
- Previous completion of PDC-INS-0008 or MKC-TI-005
- 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
- Drug or alcohol dependency
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TI Inhalation Powder Technosphere® Insulin Inhalation Powder and MedTone™ Inhaler Technosphere® Insulin Inhalation Powder
- Primary Outcome Measures
Name Time Method Annual Rate of Change in FEV1 From Baseline to End of Study Baseline to 48 months
- Secondary Outcome Measures
Name Time Method Change in FPG From Baseline to Last Study Measurement on Treatment (Maximum of 48 Months) Baseline to last study measurement on treatment (maximum of 48 months) Change from Baseline to last study measurement on treatment (maximum of 48 months)
Annual Rate of Change in FVC From Baseline to End of Study Baseline to 48 months Change in HbA1c From Baseline to Last Measurement on Study Drug (Maximum of 48 Months) Baseline to last measurement on study drug (maximum of 48 months Change in HbA1c from Baseline to last measurement on study drug (maximum of 48 months)
High Resolution Computerized Tomography Scans of the Chest End of study Annual Rate of Change in DLCo From Baseline to End of Study Baseline to 48 months Change in Weight in kg From Baseline to End of Study Baseline to last measurement on study drug (maximum of 48 months) Baseline to last measurement on study drug (maximum of 48 months)
Trial Locations
- Locations (39)
Dorothy L & James E Frank Diabetes Research Institute
🇺🇸San Mateo, California, United States
Sansum Medical Research Institute
🇺🇸Santa Barbara, California, United States
Soundview Research Associates
🇺🇸Norwalk, Connecticut, United States
International Diabetes Center
🇺🇸Minneapolis, Minnesota, United States
University of Miami School of Medicine
🇺🇸Miami, Florida, United States
Diabetes Care & Information Center of New York
🇺🇸Flushing, New York, United States
Texas Diabetes Institute
🇺🇸San Antonio, Texas, United States
Endocrine Research - Physician's East PA
🇺🇸Greenville, North Carolina, United States
Diabetes Team Associated
🇺🇸New York, New York, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Dallas Diabetes & Endocrine Center
🇺🇸Dallas, Texas, United States
Your Diabetes Endocrine Nutrition Group
🇺🇸Mentor, Ohio, United States
Diabetes Care Center
🇺🇸Seattle, Washington, United States
Diabetes & Glandular Disease Research Assoc PA
🇺🇸San Antonio, Texas, United States
MBAL Alexandrovska Hospital
🇧🇬Sofia, BGR, Bulgaria
Military Hospital in Brno
🇨🇿Brno, CZE, Czech Republic
Hospital of "Milosrdnych brain"
🇨🇿Brno, CZE, Czech Republic
Surgery of Diabetology (Brno)
🇨🇿Brno, Czech Republic
ikfe Berlin
🇩🇪Berlin, DEU, Germany
MBAL "Pleven"
🇧🇬Pleven, BGR, Bulgaria
The Hospital of Central Connecticut
🇺🇸New Britain, Connecticut, United States
Oschner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Alliance Medical Group of Greater Waterbury
🇺🇸Middlebury, Connecticut, United States
SBALENG-Sofia Institute of Endocrinology
🇧🇬Sofia, BGR, Bulgaria
Military Medical Academy
🇧🇬Sofia, Bulgaria
Central Clinical Base
🇧🇬Sofia, BGR, Bulgaria
MBAL "Sweta Marina" - Varna
🇧🇬Varna, BGR, Bulgaria
II-nd MBAL
🇧🇬Sofia, Bulgaria
University Hospital in Brno
🇨🇿Brno-Bohunice, CZE, Czech Republic
Surgery of Diabetology
🇨🇿Melnik, CZE, Czech Republic
University Hospital of 3rd Faculty
🇨🇿Prague 10, CZE, Czech Republic
Diabetologicka oridnace
🇨🇿Prague 2, CZE, Czech Republic
General Hospital in Prague and 1st Faculty of Medicine of
🇨🇿Prague 2, CZE, Czech Republic
Institute for Clinical and Exp Medicine
🇨🇿Prague 4, CZE, Czech Republic
University Hospital Na Bulovce
🇨🇿Prague 8, CZE, Czech Republic
Surgery of Diabetology Petrovice
🇨🇿Prague, CZE, Czech Republic
Surgery of Diabetology Stodulky
🇨🇿Prague, CZE, Czech Republic
Surgery of Diabetology Slany
🇨🇿Slany, CZE, Czech Republic
Surgery of Diabetology Zastavka
🇨🇿Zastavka, Brno, CZE, Czech Republic