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

Effect of Different Doses of Inhaled Technosphere Insulin on Glucose Infusion Rates During Euglycemic Clamps in Comparison to a Subcutaneous Injection of Regular Human Insulin

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Technosphere Insulin; Drug: Technosphere insulin; Drug: Regular human insulin

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Technosphere insulin inhalation system, 25 units	Drug: Technosphere Insulin
Experimental: Technosphere insulin inhalation system, 50 units	Drug: Technosphere insulin
Experimental: Technosphere insulin inhalation system, 100 units	Drug: Technosphere insulin
Active Comparator: Subcutaneous regular human insulin	Drug: Regular human insulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Mannkind Corporation

Study record dates

Study Major Dates

• Study Start: August 1, 1999
• Primary Completion (Actual): February 1, 2000
• Study Completion (Actual): June 1, 2000

Study Registration Dates

• First Submitted: August 3, 2007
• First Submitted That Met QC Criteria: August 3, 2007
• First Posted (Estimate): August 6, 2007

Study Record Updates

• Last Update Posted (Estimate): June 26, 2012
• Last Update Submitted That Met QC Criteria: June 25, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Healthy Patients
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: PDC-INS-0002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No