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

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ClinicalTrials.gov Identifier: NCT00511979
Recruitment Status : Completed
First Posted : August 6, 2007
Last Update Posted : June 26, 2012
Sponsor:
Information provided by (Responsible Party):
Mannkind Corporation

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Technosphere Insulin Drug: Technosphere insulin Drug: Regular human insulin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 1999
Actual Primary Completion Date : February 2000
Actual Study Completion Date : June 2000

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 [ Time Frame: crossover every 3-28 days for up to 20 weeks ]
  2. 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 [ Time Frame: crossover every 3-28 days for up to 20 weeks ]

Secondary Outcome Measures :
  1. Safety variables included adverse events (AEs), clinical laboratory tests, HbA1c, pulmonary function tests, vital signs, physical examinations, and diabetes-specific signs (ie, hypoglycemia) [ Time Frame: crossover every 3-28 days for up to 20 weeks ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Responsible Party: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT00511979     History of Changes
Other Study ID Numbers: PDC-INS-0002
First Posted: August 6, 2007    Key Record Dates
Last Update Posted: June 26, 2012
Last Verified: June 2012

Keywords provided by Mannkind Corporation:
Healthy Patients

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs