Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma

Stopped early · Phase 3

Conditions studied: Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Asthma

In brief

The clinical trial is designed to evaluate the safety of inhaled Technosphere/Insulin compared with non-inhaled anti-diabetic therapies in subjects with type 1 or type 2 diabetes mellitus and concurrent asthma.

Key facts

Study ID

NCT00332826

Run by

Mannkind Corporation

People needed

3

Starts

2006-06-01

Expected to finish

2007-10-01

Last updated by the study team

2012-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A clinical diagnosis of Step 1 to 3 asthma as per the NAEPP guidelines
• Clinical diagnosis of Type 1 or Type 2 diabetes mellitus for at least 1 year
• Current stable anti-diabetic regimen (insulin alone or in combination with oral anti-hyperglycemic agents)
• Subjects must exhibit <30% variability in PEF measurements during the 2 week run in period.
• Subjects must not meet any criteria for exacerbations of asthma during the 2 week run in period
• Body mass index (BMI) < 40kg/m2
• HbA1c >6.0% to <11.5%

You may not qualify if…

• Severe complications of diabetes in the opinion of the investigator
• Seizure disorder
• Significant cardiovascular dysfunction and/or history within 3 months of screening
• Hypertension with systolic blood pressure of !80 mm Hg and/or diastolic blood pressure >110 mm HG at screening despite pharmacologic therapy.
• Clinical nephrotic syndrome or renal dysfunction or disease
• Total daily insulin requirement of >1.4 U/kg body weight
• Clinical diagnosis of Step 4 asthma
• Use of >6 puffs/day of fast acting bronchodilator
• Currently using an insulin delivery pump
• Use of Pramlintide acetate or any incretins must be discontinued 8 weeks prior to screening
• Two or more severe hypoglycemic episodes within the past 6 months.
• Any hospitalization or emergency room visit due to poor diabetic control with 6 months of screening.
• Current use of systemic steroids
• Subjects who currently smoke tobacco or who have smoked within the past 6 months
• Urine cotinine test of > 100ng/ml
• Current drug or alcohol abuse
• Clinically significant abnormalities on screening laboratory evaluation
• Cancer within the past 5 years or any history of lung neoplasms
• History of active and/or cirrhotic hepatic disease and/or abnormal liver enzymes.
• Active infection or history of severe infection with 30 days of screening.
• Anemia
• History of anaphylaxis and/or angioneurotic edema
• Diagnosis of chronic obstructive pulmonary disease (COPE)
• Previous exposure to any inhaled insulin product

Where it is running

• Northwest Medical Center — Phoenix, Arizona, United States
• Premiere Pharmaceutical Research LLC — Tempe, Arizona, United States
• Canyon Internal Medicine — Tucson, Arizona, United States
• Associated Pharmaceutical Research Center Inc — Buena Park, California, United States
• Family Medical Center — Foothill Ranch, California, United States
• Health Care Partners Medical Group — Long Beach, California, United States
• Golden Pine Clinical Research — Long Beach, California, United States
• Keck USC School of Medicine — Los Angeles, California, United States
• Pinaccle Trials Inc (SMO) — Atlanta, Georgia, United States
• Executive Health and Research Associates Inc — Atlanta, Georgia, United States
• Atlanta Pharmaceutical Research Center — Dunwoody, Georgia, United States
• Southeastern Endocrine & Diabetes — Roswell, Georgia, United States
• Cedar-Crosse Research Center — Chicago, Illinois, United States
• Franklin Square Hospital — Baltimore, Maryland, United States
• Healthcare Research — Florissant, Missouri, United States
• MedEx Healthcare Research Inc(009) — St Louis, Missouri, United States
• Billings Clinic Research Division — Billings, Montana, United States
• Your Doctors Care — Hillsborough, New Jersey, United States
• Hopewell Valley Family Medicine PA — Trenton, New Jersey, United States
• Eastside Comprehensive Medical Center — New York, New York, United States
• Carolinas Research — Concord, North Carolina, United States
• Cleveland Clinic Dept of Endocrinology — Cleveland, Ohio, United States
• Diabetes & Glandular Disease Research Assoc PA — San Antonio, Texas, United States
• McLennan County Medical Education and Research Foundation — Waco, Texas, United States
• Arizona Research Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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