A 2-Month Safety Follow-Up Trial

A 2-Month Safety Follow-up Trial of Subjects From MannKind Protocols MKC-TI-009, MKC-TI-102, MKC-TI-103 and MKC-TI-030

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00741429

Enrollment

649

Registered

2008-08-26

Start date

2007-05-31

Completion date

2008-09-30

Last updated

2014-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes, Type 2 Diabetes

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.

Interventions

DRUGTechnosphere Insulin Inhalation Powder

Subjects previously treated with Technosphere Insulin Inhalation Powder

DRUGComparator

Subjects previously treated with other anti-diabetic medications

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Change in FVC (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126	3 Months
Change in FVC (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126	9 to 27 months
Change in TLC (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126	9 to 27 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
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

Countries

Brazil, Canada, Russia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026