Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes

This study has been completed.

First Received: March 27, 2006 Last Updated: May 19, 2009 History of Changes

Sponsored by:	Mannkind Corporation
Information provided by:	Mannkind Corporation
ClinicalTrials.gov Identifier:	NCT00308308

Purpose

To determine the safety and efficacy of inhaled insulin in the treatment of type 1 diabetes

Condition	Intervention	Phase
Diabetes, Type I	Drug: Technosphere Insulin Drug: Active comparator	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	A Prospective, Multi-Center, Open-Label, Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety in Subjects With Type 1 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Basal and Prandial Insulin Over a 52-Week Treatment Period and a 4-Week Follow Up

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin

U.S. FDA Resources

Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:

Compare the mean change from baseline to Week 52 in HbA1c [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment:	587
Study Start Date:	February 2006
Study Completion Date:	August 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Technosphere Insulin	Drug: Technosphere Insulin Inhalation, 15U/30U
2: Active Comparator Comparator	Drug: Active comparator sc based on the subjects HBGM measurement

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Clinical diagnosis of type 1 diabetes for at least 1 year Nonsmokers for prior 6 months BMI less than or equal to 35kg/m2 HbA1C> or = 7% and < or = 11% Serum creatinine < or = 1.8 mg/dL in female subjects and < or = 2.0 mg/dL in male subjects FEV1> or = 70% of predicted, DLco > or = 70% , TLC > or = 80% predicted Maintenance of a treatment regimen of insulin less than or equal to 1.4 iu/kg/day Urine cotinine < or = 100 ng/mL

Exclusion Criteria:

History of Chronic obstructive pulmonary disease Asthma Any other clinically significant pulmonary disease confirmed by documented history, pulmonary function testing or radiologic findings Evidence of severe complications of diabetes Aminotransferase and/or alanine aminotransferase > than 3 times the upper limit of normal

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308308

Show 130 Study Locations

Sponsors and Collaborators

Mannkind Corporation

More Information

No publications provided

Responsible Party:	MannKind Corporation ( Anders Boss, MD, MFPM, Chief Medical Officer )
Study ID Numbers:	MKC-TI-009
Study First Received:	March 27, 2006
Last Updated:	May 19, 2009
ClinicalTrials.gov Identifier:	NCT00308308 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hypoglycemic Agents
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases

Diabetes Mellitus Type 1
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1
Physiological Effects of Drugs

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on July 02, 2009