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

NCT ID: NCT00511979

Last Updated: 2012-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-08-31
• Study Completion Date: 2000-06-30

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Technosphere insulin inhalation system, 25 units

Group Type: EXPERIMENTAL

Technosphere Insulin

Intervention Type: DRUG

Technosphere insulin inhalation system, 50 units

Group Type: EXPERIMENTAL

Technosphere insulin

Intervention Type: DRUG

Technosphere insulin inhalation system, 100 units

Group Type: EXPERIMENTAL

Technosphere insulin

Intervention Type: DRUG

Subcutaneous regular human insulin

Group Type: ACTIVE_COMPARATOR

Regular human insulin

Intervention Type: DRUG

Interventions

Technosphere Insulin

Intervention Type: DRUG

Technosphere insulin

Intervention Type: DRUG

Technosphere insulin

Intervention Type: DRUG

Regular human insulin

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mannkind Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

PDC-INS-0002

Identifier Type: -

Identifier Source: org_study_id