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An Open-label, Multi-center, International, Three-year, Safety and Tolerability 'Follow on' Trial

This study has been completed.
Sponsor:
Information provided by:
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00754624
First received: September 16, 2008
Last updated: October 1, 2009
Last verified: October 2009
History of Changes

September 16, 2008
October 1, 2009
May 2004
June 2008   (final data collection date for primary outcome measure)
To evaluate the safety and tolerability of inhaled Technosphere®/Insulin in subjects with type 2 diabetes who have previously completed enrollment in one of the following MannKind Corporation clinical trials; PDC-INS-0008 & MKC-TI-005 [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00754624 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
An Open-label, Multi-center, International, Three-year, Safety and Tolerability 'Follow on' Trial
A Three-year, Safety and Tolerability, Open-Label, 'Follow on' Trial Evaluating Technosphere /Insulin in Subjects With Type 2 Diabetes Mellitus.

Safety Follow-Up Trial to PDC-INS-0008 and MKC-TI-005
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
Drug: Technosphere®/ Insulin 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
Experimental: 1
Intervention: Drug: Technosphere®/ Insulin and MedTone™ Inhaler
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
228
October 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Bulgaria,   Czech Republic,   Germany
 
NCT00754624
MKC-TI-010
Not Provided
Anders Boss, Chief Medical Officer & Senior Vice President, MannKind Corporation
Mannkind Corporation
Not Provided
Study Director: Anders Boss, MD Mannkind Corporation
Mannkind Corporation
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP