Comparison of the Effect on the Glucose Infusion Rates Between Inhaled Technosphere Insulin and a Subcutaneous Injection of Regular Human Insulin

MannKind

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Regular human insulin; Drug: Technosphere Insulin; Drug: Technosphere insulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00511979

PDC-INS-0002

Details and patient eligibility

About

A prospective, single center, open randomized, six way crossover study comparing the dose response effect of four different doses of Technosphere Insulin after pulmonary function delivery in comparison to s.c. injection of two different doses of regular human insulin.

Enrollment: 12 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects must be in good health, as judge by brief history and physical examination.
• Sex: both, male and female.
• Age: 18-40 years.
• Body mass index: 18-27 kg/m2.
• Capability to reach peak inspiratory flow of >41/sec measured by a computer assisted spirometry.
• FEV1 equal to or greater than 80% of predicted normal.

Exclusion criteria

• Diabetes Mellitus type 1 or type 2.
• Human insulin antibodies.
• Anamnestic history of hypersensitivity to the study medication or to drugs with similar chemical structures.
• Having a history of severe or multiple allergies.
• Treatment with any other investigational drug in the last three months before study entry.
• Progressive fatal disease.
• History of significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and /or hematological disease.
• Having ongoing respiratory tract infection.
• Smoker defined as subjects with evidence or history of tobacco or nicotine use in the last year prior to entry in the study.
• Blood donation within the last 30 days.
• A woman who is lactating.
• Pregnant women or women intending to become pregnant during the study.
• A sexually active woman of childbearing age not actively practicing birth control or using medically accepted device or therapy.
• A lack of compliance or other reasons, which prevent to the opinion of the investigator the participation of the subject in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

Technosphere insulin inhalation system, 25 units

Experimental group

Treatment:

Drug: Technosphere Insulin

Technosphere insulin inhalation system, 50 units

Experimental group

Treatment:

Drug: Technosphere insulin

Drug: Technosphere insulin

Technosphere insulin inhalation system, 100 units

Experimental group

Treatment:

Drug: Technosphere insulin

Drug: Technosphere insulin

Subcutaneous regular human insulin

Active Comparator group

Treatment:

Drug: Regular human insulin