A 2-Month Safety Follow-Up Trial

MannKind

Status

Completed

Conditions

Type 1 Diabetes

Type 2 Diabetes

Treatments

Drug: Technosphere Insulin Inhalation Powder

Drug: Comparator

Study type

Observational

Funder types

Industry

Identifiers

NCT00741429

MKC-TI-126

Details and patient eligibility

About

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.

Full 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.

Enrollment

649 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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