Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes

This study has been completed.

Sponsor:

Information provided by:

Mannkind Corporation

ClinicalTrials.gov Identifier:

NCT00308737

First received: March 28, 2006

Last updated: October 1, 2009

Last verified: October 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	March 28, 2006
Last Updated Date	October 1, 2009
Start Date ^ICMJE	June 2005
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 28, 2008)	To evaluate and compare changes in pulmonary function [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: March 28, 2006)	Compare the incidence of a decrease in FEV1 of 15% or more Evaluate and compare changes in pulmonary function as measured by forced expiratory volume in 1 second (FEV1)
Change History	Complete list of historical versions of study NCT00308737 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 28, 2008)	To evaluate and compare glycemic control [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: March 28, 2006)	Evaluate and compare the change in forced vital capacity (FVC), total lung capacity (TLC) and single–breath carbon monoxide diffusing capacity of the lung (DLco) Evaluate the incidence of a decrease in FVC or TLC of 15% or more, or a decrease in DLco of more than 3 mLCO/min/mmHg Evaluate and compare HbA1c between the 2 diabetes treatment groups and to evaluate and compare the incidence and frequency of defined hypoglycemia between the 2 diabetes treatment groups Evaluate and compare changes in lung function between subjects with diabetes and subjects without abnormalities in glucose metabolism Compare changes in diabetes treatment groups as a function of baseline glycemic control.
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes
Official Title ^ICMJE	Pulmonary Outcomes Within a 2-Year Period in Subjects With Diabetes Mellitus Treated With Technosphere /Insulin or Usual Antidiabetic Treatment and in Subjects Without Abnormalities in Glucose Control.
Brief Summary	Pulmonary Safety in Diabetics with T/I
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Diabetes, Type I Diabetes Type 2
Intervention ^ICMJE	Drug: Technosphere Insulin Inhalation, 15U/30U Drug: Usual Care Subjects will receive antidiabetes treatment at the discretion of their physicians Other: No Intervention No intervention
Study Arm (s)	Experimental: 1 Technosphere Insulin Intervention: Drug: Technosphere Insulin 2 Usual care Intervention: Drug: Usual Care No Intervention: 3 Subjects without abnormalities in glucose control Intervention: Other: No Intervention
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
Estimated Enrollment ^ICMJE	2343
Completion Date	October 2008
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: For All Subjects: Nonsmoking Body mass index <42 kg/m2 FEV1 greater than or equal to 70% of predicted , DLco and TLC greater than or equal to 80% of predicted at screening, No abnormalities in screening pulmonary radiology For Subjects with diabetes mellitus: Type 1 or type 2 diabetes for at least 2 years HbA1c greater than or equal to 6.6 % and less than or equal to 12.0 % For Subjects without abnormalities in glucose control: No history of diabetes Normal results from a formal glucose tolerance test Exclusion Criteria: History of chronic obstructive pulmonary disease, asthma, or other significant pulmonary disease Significant renal, hepatic, or cardiac disease Women who are pregnant, lactating, or planning on becoming pregnant Subjects who have participated in studies of other investigational drugs within the previous 3 months Evidence of severe complications of diabetes
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada, Czech Republic, Poland, Russian Federation, Spain, Ukraine, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00308737
Other Study ID Numbers ^ICMJE	MKC-TI-030
Has Data Monitoring Committee	Not Provided
Responsible Party	Anders Boss, MD, MFPM, Chief Medical Officer & Senior Vice President, MannKind Corporation
Study Sponsor ^ICMJE	Mannkind Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Mannkind Corporation
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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