Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-26 @ 4:00 PM
NCT ID:
NCT00747006
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00747006
Study Brief:
Protocol Section:
NCT00747006