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

October 9, 2014 updated by: Mannkind Corporation

A Four-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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

229

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Sofia, Bulgaria, 1431
        • Military Medical Academy
      • Sofia, Bulgaria, 1202
        • II-nd MBAL
    • BGR
      • Pleven, BGR, Bulgaria, 5800
        • MBAL "Pleven"
      • Sofia, BGR, Bulgaria, 1303
        • SBALENG-Sofia Institute of Endocrinology
      • Sofia, BGR, Bulgaria, 1431
        • MBAL Alexandrovska Hospital
      • Sofia, BGR, Bulgaria, 1431
        • Military Medical Academy
      • Sofia, BGR, Bulgaria, 1606
        • Central Clinical Base
      • Varna, BGR, Bulgaria, 5000
        • MBAL "Sweta Marina" - Varna
  • Czech Republic
      • Brno, Czech Republic, 612 00
        • Surgery of Diabetology (Brno)
    • CZE
      • Brno, CZE, Czech Republic, 636 00
        • Military Hospital in Brno
      • Brno, CZE, Czech Republic, 639 00
        • Hospital of "Milosrdnych brain"
      • Brno-Bohunice, CZE, Czech Republic, 625 00
        • University Hospital in Brno
      • Melnik, CZE, Czech Republic, 276 01
        • Surgery of Diabetology
      • Prague, CZE, Czech Republic, 109 00
        • Surgery of Diabetology Petrovice
      • Prague, CZE, Czech Republic, 155 00
        • Surgery of Diabetology Stodulky
      • Prague 10, CZE, Czech Republic, 100 34
        • University Hospital of 3rd Faculty
      • Prague 2, CZE, Czech Republic, 120 00
        • Diabetologicka oridnace
      • Prague 2, CZE, Czech Republic, 120 00
        • General Hospital in Prague and 1st Faculty of Medicine of
      • Prague 4, CZE, Czech Republic, 140 21
        • Institute for Clinical and Exp Medicine
      • Prague 8, CZE, Czech Republic, 180 81
        • University Hospital Na Bulovce
      • Slany, CZE, Czech Republic, 274 01
        • Surgery of Diabetology Slany
      • Zastavka, Brno, CZE, Czech Republic, 664 84
        • Surgery of Diabetology Zastavka
  • Germany
    • DEU
      • Berlin, DEU, Germany, D 10115
        • ikfe Berlin
  • United States
    • California
      • San Mateo, California, United States, 94401
        • Dorothy L & James E Frank Diabetes Research Institute
      • Santa Barbara, California, United States, 93105
        • Sansum Medical Research Institute
    • Connecticut
      • Middlebury, Connecticut, United States, 06762
        • Alliance Medical Group of Greater Waterbury
      • New Britain, Connecticut, United States, 06050
        • The Hospital of Central Connecticut
      • Norwalk, Connecticut, United States, 06851
        • Soundview Research Associates
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami School of Medicine
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Oschner Clinic Foundation
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • International Diabetes Center
    • New York
      • Flushing, New York, United States, 11365
        • Diabetes Care & Information Center of New York
      • New York, New York, United States, 10016
        • Diabetes Team Associated
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Endocrine Research - Physician's East PA
    • Ohio
      • Mentor, Ohio, United States, 44060
        • Your Diabetes Endocrine Nutrition Group
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Dallas, Texas, United States, 75230
        • Dallas Diabetes & Endocrine Center
      • San Antonio, Texas, United States, 78229
        • Diabetes & Glandular Disease Research Assoc PA
      • San Antonio, Texas, United States, 78207
        • Texas Diabetes Institute
    • Washington
      • Seattle, Washington, United States, 98105
        • Diabetes Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Annual Rate of Change in FEV1 From Baseline to End of Study
Time Frame: Baseline to 48 months
Baseline to 48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annual Rate of Change in FVC From Baseline to End of Study
Time Frame: Baseline to 48 months
Baseline to 48 months
Annual Rate of Change in DLCo From Baseline to End of Study
Time Frame: Baseline to 48 months
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)
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)
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)
Baseline to last measurement on study drug (maximum of 48 months)
High Resolution Computerized Tomography Scans of the Chest
Time Frame: End of study
End of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mannkind Corporation

Investigators

  • Study Director: Anders Boss, MD, Mannkind Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

September 16, 2008

First Submitted That Met QC Criteria

September 17, 2008

First Posted (Estimate)

September 18, 2008

Study Record Updates

Last Update Posted (Estimate)

October 16, 2014

Last Update Submitted That Met QC Criteria

October 9, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MKC-TI-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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