Status:
TERMINATED
Evaluate Safety of Technosphere® Insulin (TI) in Diabetic Subjects With Moderate Obstructive Pulmonary Disease
Lead Sponsor:
Mannkind Corporation
Conditions:
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Examine the effects of TI in combination with an anti-diabetic regimen including inhaled insulin versus anti-diabetic treatment without inhaled insulin on lung function \& pulmonary safety
Eligibility Criteria
Inclusion
- Asthma
- Physician diagnosis of asthma with history of any or all of the following: recurrent wheezing, recurrent chest tightness, recurrent difficulty breathing, or cough, particularly worse at nighttime
- Never smoked or former smokers (= 6 months since cessation)
- ≥18 years of age
- Prebronchodilator Forced Expiratory Volume in 1sec (FEV1) ≥ 60% Third National Health and Nutrition Examination Survey (NHANES III) predicted, prebronchodilator total lung capacity (TLC) ≥ 80% predicted Intermountain Thoracic Society (ITS), and prebronchodilator single breath carbon monoxide diffusing capacity of the lung (DLco) (unc) ≥70% predicted (Miller)
- \< 30% day-to-day variability in daily morning Peak expiratory Volume (PEF) during the 2-week run-in period
- Significant improvement in pre- to postbronchodilator spirometry (defined as an increase from baseline of ≥ 12% and ≥ 200 mL in FEV1 or Forced Vital Capacity \[FVC\]) at Screening/Visit 1 or documented significant improvement in pre- to postbronchodilator spirometry (as defined above) within past 12 months in subject's medical records or a documented positive methacholine challenge test within the past 12 months
- COPD
- Physician diagnosis of COPD (including emphysema and/or chronic bronchitis), history of dyspnea and/or intermittent or daily chronic cough with or without sputum production, not attributable to any other known cause
- Former smoker (≥ 6 months since cessation) with smoking history of ≥ 10 pack years
- ≥40 years of age
- Postbronchodilator FEV1/FVC ratio \< 70%
- Postbronchodilator FEV1 ≥ 50% NHANES III predicted, total lung capacity (TLC) ≥ 80% predicted ITS, and DLco (unc) ≥ 50% predicted (Miller)
- Both
- Clinical diagnosis of Type1 or 2 diabetes mellitus for ≥ 12 months and no change in anti-diabetic regiment for at least 90-days prior to screening
- BMI of, \< 39 kg/m2
- Urine cotinine level ≤ 100ng/dL
- Clinical diagnosis of obstructive lung disease
- HbA1C \> 6.5% ≤ 11.5%
Exclusion
- History of pulmonary exacerbation within 8 weeks of screening/V1 or between V1 and V2
- Use of systemic corticosteroids or antibiotics for respiratory illness within 8 weeks of screening/V1 OR between V1 and V2
- Increase from baseline in the use of short-acting bronchodilator or short-acting anticholinergic agents, or the combination of the 2, by ≥6 puffs or ≥3 nebulizer treatments per day for ≥ 2 days
- Treatment with supplemental oxygen therapy, room air oxygen saturation, 94% or history of intubation or ICU admission for respiratory illness in the past 5 yrs.
- Greater than 2 hospitalizations or ER or urgent care visits or required \>3 courses of systemic steroid in the past 12 months for respiratory illness
- Use of Symlin® (pramlintide acetate) within the preceding 90 days
- Two or more severe hypoglycemic episodes within 6 months of screening or episode of severe hypoglycemia between Screening and Baseline
- Previous exposure to any inhaled insulin product
- Currently using an insulin delivery pump
- Requires significant change (define as initiation of a new medication or change in the dose or frequency of the controller medications) in the asthma or COPD therapeutic regimen within 8 weeks of Screening/Visit 1 (Week -4) or between Visit 1 and Baseline/Visit 2
- Severe complications of diabetes mellitus, in the opinion of the PI or sub-investigator, including symptomatic autonomic neuropathy; disabling peripheral neuropathy; active proliferative retinopathy; nephropathy with renal failure, renal transplant and/or dialysis; history of foot ulcers; nontraumatic amputations due to gangrene; and/or vascular claudication
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00642616
Start Date
March 1 2009
End Date
November 1 2014
Last Update
April 14 2017
Active Locations (21)
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1
Mission Hills, California, United States, 91345
2
San Diego, California, United States, 92117
3
Palm Harbor, Florida, United States, 34684
4
Flint, Michigan, United States, 48504