A 2-Month Safety Follow-Up Trial

Mannkind Corporation649 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

649

Conditions

Type 1 Diabetes Type 2 Diabetes

Interventions

Technosphere Insulin Inhalation PowderDRUG

Subjects previously treated with Technosphere Insulin Inhalation Powder

ComparatorDRUG

Subjects previously treated with other anti-diabetic medications

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (150)

Outcomes

Primary Outcomes

Change in FEV1 (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126

Time frame: 9 to 27 months

Secondary Outcomes

Change in FVC (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126

Time frame: 9 to 27 months

Change in TLC (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126

Time frame: 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

Time frame: 9 to 27 months

Change in FEV1 (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126

Time frame: 3 Months

Change in FVC (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126

Time frame: 3 Months

Change in TLC (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126

Time frame: 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

Time frame: 3 Months

Data from ClinicalTrials.gov

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