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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00754624
First received: September 16, 2008
Last updated: October 9, 2014
Last verified: October 2014
  Purpose

Safety Follow-Up Trial to PDC-INS-0008 and MKC-TI-005


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Technosphere® Insulin Inhalation Powder and MedTone™ Inhaler
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Four-year, Safety and Tolerability, Open-Label, "Follow on" Trial Evaluating Technosphere® Insulin in Subjects With Type 2 Diabetes Mellitus.

Resource links provided by NLM:


Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:
  • Annual Rate of Change in FEV1 From Baseline to End of Study [ Time Frame: Baseline to 48 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Annual Rate of Change in FVC From Baseline to End of Study [ Time Frame: Baseline to 48 months ] [ Designated as safety issue: Yes ]
  • Annual Rate of Change in DLCo From Baseline to End of Study [ Time Frame: Baseline to 48 months ] [ Designated as safety issue: Yes ]
  • Change in HbA1c From Baseline to Last Measurement on Study Drug (Maximum of 48 Months) [ Time Frame: Baseline to last measurement on study drug (maximum of 48 months ] [ Designated as safety issue: No ]
    Change in HbA1c from Baseline to last measurement on study drug (maximum of 48 months)

  • Change in FPG From Baseline to Last Study Measurement on Treatment (Maximum of 48 Months) [ Time Frame: Baseline to last study measurement on treatment (maximum of 48 months) ] [ Designated as safety issue: No ]
    Change from Baseline to last study measurement on treatment (maximum of 48 months)

  • Change in Weight in kg From Baseline to End of Study [ Time Frame: Baseline to last measurement on study drug (maximum of 48 months) ] [ Designated as safety issue: No ]
    Baseline to last measurement on study drug (maximum of 48 months)

  • High Resolution Computerized Tomography Scans of the Chest [ Time Frame: End of study ] [ Designated as safety issue: Yes ]

Enrollment: 229
Study Start Date: May 2004
Study Completion Date: October 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TI Inhalation Powder
Technosphere® Insulin Inhalation Powder
Drug: 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

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754624

  Show 40 Study Locations
Sponsors and Collaborators
Mannkind Corporation
Investigators
Study Director: Anders Boss, MD Mannkind Corporation
  More Information

No publications provided

Responsible Party: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT00754624     History of Changes
Other Study ID Numbers: MKC-TI-010
Study First Received: September 16, 2008
Results First Received: July 22, 2014
Last Updated: October 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014