Open-Label, Randomized Trial to Evaluate Safety of Technosphere Insulin (T/I) in Type 1&2 Diabetics With Mild COPD

This study is not yet open for participant recruitment.

Verified by Mannkind Corporation, March 2008

First Received: March 21, 2008 Last Updated: March 24, 2008 History of Changes

Sponsored by:	Mannkind Corporation
Information provided by:	Mannkind Corporation
ClinicalTrials.gov Identifier:	NCT00642616

Purpose

Examine the effects of T/I in combination with an anti-diabetic regimen of insulin vs. anti-diabetic treatment on lung function & pulmonary safety

Condition	Intervention	Phase
Diabetic Type 1 With Obstructive Pulmonary Disease Diabetic Type 2 With Obstructive Pulmonary Disease	Drug: Technosphere Insulin Drug: Usual Care	Phase III

Drug Information available for: Insulin

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title:	A Phase 3, Multi-Center, Open-Label, Randomized Clinical Trial to Evaluate the Safety of Technosphere® Insulin Inhalation Powder in Type 1 or Type 2 Diabetic Subjects With Mild Obstructive Pulmonary Disease Over a 12-Month Treatment Period With a 3-Month Follow-Up

Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:

Comparison between the TI and UC Treatment Groups, with respect to change in post-bronchodilator FEV1 from Visit 1 to Final Visit. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Additional changes to lung function [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	474
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Technosphere Insulin	Drug: Technosphere Insulin Inhalation Powder, 15/30U, prandial
2 Usual Care	Drug: Usual Care Subjects will receive anti-diabetic care at the discretion of their physician

Eligibility

Criteria

Inclusion Criteria:

Clinical diagnosis of Type 1 or 2 diabetes for 12 months and no change in anti-diabetic regiment for at least 90-days prior to screening
BMI of 35 kg/m2. A1C 7.0 -10.0.
Non-smoker & urine cotinine level <100ng/dL
Clinical diagnosis of obstructive lung disease

Exclusion Criteria:

History of pulmonary exacerbation with 8 wks of screening/V1
Post-bronchodilator FEV1 <55%, FVC <70% NHANES III predicted, performed at the clinical site using office spirometry
History of systemic corticosteroid or antibiotic use of respiratory illness within 8 weeks of V1
Treatment with >4 puffs or >2 nebulizer treatments a day of inhaled short-acting beta agonist or short-acting anti-cholinergic agents of a combination of the 2.
Treatment with supplemental oxygen therapy, room air oxygen saturation, 94% or history of intubation or ICU admission for respiratory illness in the past 5 yrs.
Greater than 2 hospitalizations or ER visits or required >3 courses of systemic steroid in the past 12 mos. for respiratory illness

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642616

Contacts

Contact: MannKind Investigational Site

1-888-493-8622

Sponsors and Collaborators

Mannkind Corporation

Investigators

Study Chair:

Anders Boss

Mannkind Corporation

More Information

No publications provided

Responsible Party:	MannKind Corporation ( Anders Hasager Boss, MD, MFPM )
Study ID Numbers:	MKC-TI-134
Study First Received:	March 21, 2008
Last Updated:	March 24, 2008
ClinicalTrials.gov Identifier:	NCT00642616 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Lung Diseases, Obstructive
Hypoglycemic Agents
Respiratory Tract Diseases

Lung Diseases
Respiration Disorders
Insulin

Additional relevant MeSH terms:

Lung Diseases, Obstructive
Hypoglycemic Agents
Respiratory Tract Diseases
Lung Diseases

Physiological Effects of Drugs
Respiration Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on May 07, 2009