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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00754624
First Posted: September 18, 2008
Last Update Posted: October 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mannkind Corporation
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Annual Rate of Change in FVC From Baseline to End of Study [ Time Frame: Baseline to 48 months ]
  • Annual Rate of Change in DLCo From Baseline to End of Study [ Time Frame: Baseline to 48 months ]
  • 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 ]
    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) ]
    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) ]
    Baseline to last measurement on study drug (maximum of 48 months)

  • High Resolution Computerized Tomography Scans of the Chest [ Time Frame: End of study ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00754624


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

Responsible Party: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT00754624     History of Changes
Other Study ID Numbers: MKC-TI-010
First Submitted: September 16, 2008
First Posted: September 18, 2008
Results First Submitted: July 22, 2014
Results First Posted: October 16, 2014
Last Update Posted: October 16, 2014
Last Verified: October 2014

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