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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Mannkind Corporation

ClinicalTrials.gov Identifier:

NCT00511979

First received: August 3, 2007

Last updated: June 25, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	August 3, 2007
Last Updated Date	June 25, 2012
Start Date ^ICMJE	August 1999
Primary Completion Date	February 2000 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 25, 2012)	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 ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00511979 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 25, 2012)	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 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Comparison of the Effect on the Glucose Infusion Rates Between Inhaled Technosphere Insulin and a Subcutaneous Injection of Regular Human Insulin
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Healthy
Intervention ^ICMJE	Drug: Technosphere Insulin Drug: Technosphere insulin Drug: Regular human insulin
Study Arm (s)	Experimental: Technosphere insulin inhalation system, 25 units Intervention: Drug: Technosphere Insulin Experimental: Technosphere insulin inhalation system, 50 units Intervention: Drug: Technosphere insulin Experimental: Technosphere insulin inhalation system, 100 units Intervention: Drug: Technosphere insulin Active Comparator: Subcutaneous regular human insulin Intervention: Drug: Regular human insulin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	12
Completion Date	June 2000
Primary Completion Date	February 2000 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 40 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00511979
Other Study ID Numbers ^ICMJE	PDC-INS-0002
Has Data Monitoring Committee	Not Provided
Responsible Party	Mannkind Corporation
Study Sponsor ^ICMJE	Mannkind Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Mannkind Corporation
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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