Clinical trial NCT00754624: An Open-label, Multi-center, International, Three-year, Safety and Tolerability 'Follow on' Trial
Official title: A Four-year, Safety and Tolerability, Open-Label, "Follow on" Trial Evaluating Technosphere® Insulin in Subjects With Type 2 Diabetes Mellitus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Mannkind Corporation
Sponsor class: INDUSTRY
First posted: 2008-09-18
Enrollment: 229
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Annual Rate of Change in FEV1 From Baseline to End of Study
timeFrame: Baseline to 48 months
Secondary outcomes:
measure: Annual Rate of Change in FVC From Baseline to End of Study
timeFrame: Baseline to 48 months
measure: Annual Rate of Change in DLCo From Baseline to End of Study
timeFrame: Baseline to 48 months
measure: Change in HbA1c From Baseline to Last Measurement on Study Drug (Maximum of 48 Months)
timeFrame: Baseline to last measurement on study drug (maximum of 48 months
measure: Change in FPG From Baseline to Last Study Measurement on Treatment (Maximum of 48 Months)
timeFrame: Baseline to last study measurement on treatment (maximum of 48 months)
measure: Change in Weight in kg From Baseline to End of Study
timeFrame: Baseline to last measurement on study drug (maximum of 48 months)
measure: High Resolution Computerized Tomography Scans of the Chest
timeFrame: End of study
Other outcomes:
Locations:
city: San Mateo
country: United States
facility: Dorothy L & James E Frank Diabetes Research Institute
state: California
city: Santa Barbara
country: United States
facility: Sansum Medical Research Institute
state: California
city: Middlebury
country: United States
facility: Alliance Medical Group of Greater Waterbury
state: Connecticut
city: New Britain
country: United States
facility: The Hospital of Central Connecticut
state: Connecticut
city: Norwalk
country: United States
facility: Soundview Research Associates
state: Connecticut
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: New Orleans
country: United States
facility: Oschner Clinic Foundation
state: Louisiana
city: Minneapolis
country: United States
facility: International Diabetes Center
state: Minnesota
city: Flushing
country: United States
facility: Diabetes Care & Information Center of New York
state: New York
city: New York
country: United States
facility: Diabetes Team Associated
state: New York
city: Greenville
country: United States
facility: Endocrine Research - Physician's East PA
state: North Carolina
city: Mentor
country: United States
facility: Your Diabetes Endocrine Nutrition Group
state: Ohio
city: Dallas
country: United States
facility: Dallas Diabetes & Endocrine Center
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: San Antonio
country: United States
facility: Texas Diabetes Institute
state: Texas
city: San Antonio
country: United States
facility: Diabetes & Glandular Disease Research Assoc PA
state: Texas
city: Seattle
country: United States
facility: Diabetes Care Center
state: Washington
city: Pleven
country: Bulgaria
facility: MBAL "Pleven"
state: BGR
city: Sofia
country: Bulgaria
facility: SBALENG-Sofia Institute of Endocrinology
state: BGR
city: Sofia
country: Bulgaria
facility: MBAL Alexandrovska Hospital
state: BGR
city: Sofia
country: Bulgaria
facility: Military Medical Academy
state: BGR
city: Sofia
country: Bulgaria
facility: Central Clinical Base
state: BGR
city: Varna
country: Bulgaria
facility: MBAL "Sweta Marina" - Varna
state: BGR
city: Sofia
country: Bulgaria
facility: II-nd MBAL
city: Sofia
country: Bulgaria
facility: Military Medical Academy
city: Brno-Bohunice
country: Czech Republic
facility: University Hospital in Brno
state: CZE
city: Brno
country: Czech Republic
facility: Military Hospital in Brno
state: CZE
city: Brno
country: Czech Republic
facility: Hospital of "Milosrdnych brain"
state: CZE
city: Melnik
country: Czech Republic
facility: Surgery of Diabetology
state: CZE
city: Prague 10
country: Czech Republic
facility: University Hospital of 3rd Faculty
state: CZE
city: Prague 2
country: Czech Republic
facility: Diabetologicka oridnace
state: CZE
city: Prague 2
country: Czech Republic
facility: General Hospital in Prague and 1st Faculty of Medicine of
state: CZE
city: Prague 4
country: Czech Republic
facility: Institute for Clinical and Exp Medicine
state: CZE
city: Prague 8
country: Czech Republic
facility: University Hospital Na Bulovce
state: CZE
city: Prague
country: Czech Republic
facility: Surgery of Diabetology Petrovice
state: CZE
city: Prague
country: Czech Republic
facility: Surgery of Diabetology Stodulky
state: CZE
city: Slany
country: Czech Republic
facility: Surgery of Diabetology Slany
state: CZE
city: Zastavka, Brno
country: Czech Republic
facility: Surgery of Diabetology Zastavka
state: CZE
city: Brno
country: Czech Republic
facility: Surgery of Diabetology (Brno)
city: Berlin
country: Germany
facility: ikfe Berlin
state: DEU
Study officials:
affiliation: Mannkind Corporation
name: Anders Boss, MD
role: STUDY_DIRECTOR
References: