To Compare the Effect of Inhaled Insulin With Subcutaneously Injected Insulin in Subjects With Type 2 Diabetes Mellitus.

Mannkind Corporation1 site in 1 country16 target enrollmentOctober 2003

Overview

This trial was designed to compare meal related inhalation of Technosphere/Insulin to subcutaneous regular insulin in patients with type 2 diabetes.

Registry

clinicaltrials.gov

Start Date

October 2003

End Date

April 2004

Last Updated

16 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Sponsor

•Clinical diagnosis of type 2 diabetes mellitus.
•Current regimen of intensified insulin therapy for at least 6 months.
•Body Mass Index less than 35 kg/m
•HbA1c less than or equal to 9%.
•Non-smoker for at least 2 years.
•If medications in addition to insulin are taken at screening, the patient must be on a stable regimen as defined by continued use of the same dose of each medication for a period of at least three months.
•Forced vital capacity (FVC), forced expiratory volume in one second (FEV1), forced mid-expiratory flow rate 25 %-75 % (FEF25-75), slow vital capacity (SVC) as measured by spirometry, and single-breath carbon monoxide diffusing capacity corrected for hemoglobin and carboxyhemoglobin (DLco), all greater than or equal to 80 % of expected normal.
•Ability to perform PFT, without coughing within the first 5 seconds of test.
•Written informed consent.

•Diabetes mellitus type
•Current treatment (within the last 30 days) with oral antidiabetic agents.
•Regular pre-prandial doses of regular insulin of more than 30 IU.
•Intake of any drug or herbal preparation which, in the evaluation of the investigator, may interfere with the interpretation of trial results or that is known to cause clinically relevant interference with insulin action, glucose utilization or recovery from hypoglycemia (e.g. systemic steroids).
•History of hypersensitivity to the study drug or to drugs with similar chemical structures.
•Treatment with any other investigational drug within three months prior to enrollment in study.
•Progressive fatal disease.
•History of malignancy within five years of study entry (other than basal cell epithelioma).
•History of drug or alcohol abuse.
•Evidence of severe secondary complications of diabetes (neuropathy, nephropathy as evidence by creatinine \> 1.5 for females or \> 1.8 for males, retinopathy, or severe peripheral vascular disease).

Glycemic response to a meal challenge

Serum insulin concentrations measured for Technosphere/Insulin administration and subcutaneous insulin administration across 13 time points over a 270 minute period
Safety variables