Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes - Full Text View

Sponsored by:	Mannkind Corporation
Information provided by:	Mannkind Corporation
ClinicalTrials.gov Identifier:	NCT00308737

Purpose

Pulmonary Safety in Diabetics with T/I

Condition	Intervention	Phase
Diabetes, Type I Diabetes Type 2	Drug: Technosphere Insulin Drug: Usual Care Other: No Intervention	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Dextrose

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Official Title:	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.

Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:

To evaluate and compare changes in pulmonary function [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate and compare glycemic control [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	2343
Study Start Date:	June 2005
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Technosphere Insulin	Drug: Technosphere Insulin Inhalation, 15U/30U
2 Usual care	Drug: Usual Care Subjects will receive antidiabetes treatment at the discretion of their physicians
3: No Intervention Subjects without abnormalities in glucose control	Other: No Intervention No intervention

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308737

Sponsors and Collaborators

Mannkind Corporation

More Information

Responsible Party:	MannKind Corporation ( Anders Boss, MD, MFPM, Chief Medical Officer & Senior Vice President )
Study ID Numbers:	MKC-TI-030
Study First Received:	March 28, 2006
Last Updated:	February 28, 2008
ClinicalTrials.gov Identifier:	NCT00308737
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Congenital Abnormalities
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009