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

Home

Study Topics

Glossary


	Full Text View


	Tabular View


	Contacts and Locations


	No Study Results Posted


	Related Studies

Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes

This study is ongoing, but not recruiting participants.

Study NCT00308308. Last updated on February 28, 2008. Information provided by Mannkind Corporation

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes

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

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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 ]

Condition ^†

Diabetes, Type I

Intervention ^†

Drug: Technosphere Insulin
Drug: Human insulin aspart

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

570

Start Date ^†

February 2006

Completion Date

January 2008

Eligibility 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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States, Argentina, Brazil, Canada, Chile, Mexico, Poland, Russian Federation, Spain, United Kingdom

Administrative Information Fields

NCT ID ^†

NCT00308308

Organization ID

MKC-TI-009

Secondary IDs ^††

Study Sponsor ^†

Mannkind Corporation

Collaborators ^††

Investigators ^†

Study Director:

Anders Boss

Mannkind Corporation

Information Provided By

Mannkind Corporation

Verification Date

February 2008

First Received Date ^†

March 27, 2006

Last Updated Date

February 28, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.