Patient Transitioning From Exubera® Inhalation Powder to Technosphere® Insulin Inhalation Powder

MannKind

Status

Conditions: Type 1 Diabetes; Type 2 Diabetes

Treatments: Drug: Technosphere Insulin Inhalation Powder

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT01798914

MKC-TI-139

Details and patient eligibility

About

The purpose of this study is to allow patients with specific needs for inhaled insulin to continue with inhaled insulin therapy using Technosphere Insulin after Exubera was withdrawn from the market.

Full description

A Phase 3, open label, multicenter, safety follow up trial to convert the treatment of subjects currently using Exubera to treatment with TI Inhalation Powder

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has type 1 or type 2 diabetes mellitus and is currently being treated with or has been treated with Exubera.
• Subject has a severe phobia to sc injections of insulin (needle phobia) preventing conventional treatment OR has impaired sc insulin absorption

Exclusion criteria

• Smoking in the previous 6 months
• History of asthma or chronic obstructive pulmonary disease (COPD) or any other significant pulmonary disease, or exposure to pulmonary toxins.
• Clinically significant pulmonary abnormalities on chest high-resolution computed tomography (HRCT).
• PFT results prior to transferring to TI Inhalation Powder showing any of the following: FEV1 < 70% of predicted, FVC < 70% of predicted, DLCO < 70% of predicted, TLC < 80% of predicted.
• Allergy to insulin