Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes - Full Text View

Sponsor:	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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Medicines Diabetes Type 1

Drug Information available for: Insulin Insulin beef

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
Experimental: 1 Technosphere Insulin	Drug: Technosphere Insulin Inhalation, 15U/30U
Active Comparator: 2 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 129 Study Locations

Sponsors and Collaborators

Mannkind Corporation

More Information

No publications provided

Responsible Party:	Anders Boss, MD, MFPM, Chief Medical Officer, MannKind Corporation
ClinicalTrials.gov Identifier:	NCT00308308 History of Changes
Other Study ID Numbers:	MKC-TI-009
Study First Received:	March 27, 2006
Last Updated:	October 1, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases

Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 13, 2012