Status:
TERMINATED
Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder)When an Optimal Dose is Taken With Varied Carbohydrate Intake
Lead Sponsor:
Mannkind Corporation
Conditions:
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if, once a favorable dose of TI Inhalation Powder is established for either a type 1 or 2 patient, based on a average diabetic meal, the patient's favorable d...
Eligibility Criteria
Inclusion
- Clinical diagnoses of type 1 or type 2 diabetes mellitus
- Fasting Plasma Glucose (FPG) 80, 140 mg/dL and glycated hemoglobin (A1C) \> 6.5% and \< or = 10.0%.
- Body mass index (BMI) of \< or = 40 kg/m2
- Non-smokers (never smoked or former smokers \[= 6 months since cessation\]) and a urine cotinine level \< or = 100 ng/dL
- Forced expiratory volume in 1 second (FEV1) = 70% Third National Health and Nutrition Examination Survey (NHANES III) Predicted; pre-bronchodilator FEV1 as a percentage of forced vital capacity (FEV1/Forced vital capacity(FVC)) = 70%
- For subjects with type 2 diabetes mellitus: Currently receiving oral diabetic treatment or basal insulin +/- oral diabetic treatment
Exclusion
- History of chronic obstructive pulmonary disease (COPD), clinically proven asthma, and/or any other clinically important pulmonary disease confirmed by pulmonary function test (PFT) and/or radiologic findings
- Elevated liver function test (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] \> 3 times the normal reference range or bilirubin \> 1.5 times the reference range)
- Previous use of Exubera; use of Symlin (pramlintide acetate) and/or Byetta (exenatide) within the past 12 weeks
- Unstable diabetes control and evidence of severe complications of diabetes mellitus (ie, autonomic neuropathy)
- Exposure to any investigational product(s) in the past 12 weeks
- For subjects with type 2 diabetes mellitus: In subjects taking metformin, serum creatinine \> 1.4 mg/dL in female subjects and \> 1.5 mg/dL in male subjects
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00747006
Start Date
September 1 2008
End Date
May 1 2011
Last Update
October 30 2014
Active Locations (1)
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1
Sansum Medical Research Institute
Santa Barbara, California, United States, 93105