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

MannKind

Status and phase

Completed

Phase 2

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Technosphere® Insulin Inhalation Powder and MedTone™ Inhaler

Study type

Interventional

Funder types

Industry

Identifiers

NCT00754624

MKC-TI-010

Details and patient eligibility

About

Safety Follow-Up Trial to PDC-INS-0008 and MKC-TI-005

Full 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.

Enrollment

229 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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