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

NCT00511979 | Completed Phase 1

• 1 other identifier: PDC-INS-0002
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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

Keywords

Healthy Patients

Outcome Measures

Primary Outcomes (2)

• Dose-corrected area-under-the serum insulin concentration vs. time curve for inhaled TI and subcutaneous RHI at timepoints -120, -90, -60, 0, 1, 3, 7, 12, 20, 30, 45, 60 and 90 minutes, and 2, 3, 4, 5 and 6 hours relative to treatment

  crossover every 3-28 days for up to 20 weeks

• Area under the glucose infusion rate for inhaled TI and subcutaneous RHI at timepoints -120, -90, -60, 0, 1, 3, 7, 12, 20, 30, 45, 60 and 90 minutes, and 2, 3, 4, 5 and 6 hours relative to treatment

  crossover every 3-28 days for up to 20 weeks

Secondary Outcomes (1)

• Safety variables included adverse events (AEs), clinical laboratory tests, HbA1c, pulmonary function tests, vital signs, physical examinations, and diabetes-specific signs (ie, hypoglycemia)

  crossover every 3-28 days for up to 20 weeks

Study Arms (4)

Technosphere insulin inhalation system, 25 units

EXPERIMENTAL

Drug: Technosphere Insulin

Technosphere insulin inhalation system, 50 units

EXPERIMENTAL

Drug: Technosphere insulin

Technosphere insulin inhalation system, 100 units

EXPERIMENTAL

Drug: Technosphere insulin

Subcutaneous regular human insulin

ACTIVE COMPARATOR

Drug: Regular human insulin

Interventions

Technosphere insulin DRUG

Technosphere insulin inhalation system, 25 units

Regular human insulin DRUG

Subcutaneous regular human insulin

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mannkind Corporation: lead

MeSH Terms

Interventions

Insulin

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2007
• First Posted: August 6, 2007
• Study Start: August 1, 1999
• Primary Completion: February 1, 2000
• Study Completion: June 1, 2000
• Last Updated: June 26, 2012

Record last verified: 2012-06