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

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: Human insulin aspart	Phase III

MedlinePlus related topics:

Diabetes Diabetes Type 1

ChemIDplus related topics:

Insulin Insulin aspart

U.S. FDA Resources

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

Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:

Compare the mean change in HbA1c from baseline. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate safety of treatment by assessing clinical laboratory parameters, hypoglycemia, hyperglycemia, and other adverse events and pulmonary function tests [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	570
Study Start Date:	February 2006
Estimated Study Completion Date:	January 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 Powder, three to four times per day before meals
2: Active Comparator Human insulin aspart	Drug: Human insulin aspart Subcutaneous injection, three (3) to four times per day before meals

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 118 Study Locations

Sponsors and Collaborators

Mannkind Corporation

Investigators


Study Director:	Anders Boss	Mannkind Corporation

More Information

Responsible Party:	MannKind Corporation ( Anders Boss, MC, MFPM, Chief Medical Officer )
Study ID Numbers:	MKC-TI-009
First Received:	March 27, 2006
Last Updated:	February 28, 2008
ClinicalTrials.gov Identifier:	NCT00308308
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Autoimmune Diseases

Metabolic Diseases

Diabetes Mellitus, Type 1

Insulin, Asp(B28)-

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents

Immune System Diseases

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

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