A 2-Month Safety Follow-Up Trial

Completed

• Conditions: Type 2 Diabetes; Type 1 Diabetes
• Interventions: Drug: Comparator; Drug: Technosphere Insulin Inhalation Powder

• Registration Number: NCT00741429
• Lead Sponsor: Mannkind Corporation

Brief Summary

The main purpose of the trial is to evaluate pulmonary function in subjects who had completed any one of the 4 MKC parent trials (MKC-TI-009, MKC-TI-102, MKC-TI-103, or MKC-TI-030) for an additional 2-month safety follow-up.

Detailed Description

This was a 2-month safety follow-up study of subjects from MannKind protocols MKC-TI-009, MKC-TI-102, MKC-TI-103 and MKC-TI-030. No study medications were administered during this trial. The adverse event data included are for the combined Safety population irrespective of previous treatments in the parent trials.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2008-08-22
• Study First Submitted QC: 2008-08-25
• Study First Posted: 2008-08-26
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-01
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 649

Inclusion Criteria

• Subjects who have completed any of the 4 MKC parent trials (MKC-TI-103, MKC-TI-009, MKC-TI-102, MKC-TI-030)
• Urine cotinine test of less than or equal to 100 ng/mL
• Written informed consent

Exclusion Criteria

• Subjects who started smoking during the 4 week follow-up phase of the parent trial
• Subjects who began a new inhaled insulin regimen with an investigational drug during the 4 week follow-up phase of the parent trial and/or are participation in another clinical trial
• Female subjects who are pregnant, lactating or planning on becoming pregnant
• Subjects with a positive urine drug screening at Visit 1
• Female subjects of child-bearing potential not practicing adequate birth control

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non Ex-TI	Comparator	Non Ex-Technosphere® Insulin Inhalation Powder (subjects previously received another anti-diabetic medication)
Ex-TI	Technosphere Insulin Inhalation Powder	Ex-Technosphere® Insulin Inhalation Powder (subjects previously received TI Inhalation Powder)

Primary Outcome Measures

Name	Time	Method
Change in FEV1 (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126	9 to 27 months

Secondary Outcome Measures

Name	Time	Method
Change in TLC (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126	9 to 27 months
Change in Hemoglobin Corrected DLco (mL/min/mm Hg) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126	9 to 27 months
Change in FVC (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126	9 to 27 months
Change in FVC (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126	3 Months
Change in FEV1 (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126	3 Months
Change in TLC (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126	3 Months
Change in Hemoglobin Corrected DLco (mL/min/mmHg) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126	3 Months

Trial Locations

Locations (147)

Parkway Medical Center; 🇺🇸 Birmingham, Alabama, United States

Coastal Clinical Research Inc; 🇺🇸 Mobile, Alabama, United States

Radiant Research (Phoenix); 🇺🇸 Chandler, Arizona, United States

Southwest Health Ltd Research Division; 🇺🇸 Phoenix, Arizona, United States

Northwest Medical Center; 🇺🇸 Phoenix, Arizona, United States

Canyon Clinical Research; 🇺🇸 Tucson, Arizona, United States

Arizona Research Associates; 🇺🇸 Tuscon, Arizona, United States

Private Practice; 🇺🇸 Decatur, Georgia, United States

International Clinical Research Network; 🇺🇸 Chula Vista, California, United States

Family Medical Center; 🇺🇸 Foothill Ranch, California, United States

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