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:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-24 @ 9:17 PM
NCT ID:
NCT01196104
Eligibility Criteria:
Inclusion Criteria:
* Men and women ≥ 18 and ≤ 80 years of age
* Clinical diagnosis of type 2 diabetes mellitus for more than 12 months
* Body mass index (BMI) ≤ 45 kg/m2
* Glycated Hemoglobin (HbA1c) \> 6.5% and ≤ 10.0%
* Treatment with 1 to 3 Oral Antidiabetic Drugs (OADs) and basal insulin for a minimum of 3 months before screening. Doses of OADs must have been stable for 3 months before study entry
* Nonsmokers (includes cigarettes, cigars, pipes, and chewing tobacco) for the preceding ≥ 6 months
* Office spirometry at the investigator site
* Forced expiratory volume in 1 second (FEV1) ≥ 65% Third National Health and Nutrition Examination Survey (NHANES III) predicted
* Forced vital capacity (FVC) ≥ 65% NHANES III predicted
* Forced expiratory volume in 1 second as a percentage of forced vital capacity (FEV1/FVC) ≥ lower limit of normal (LLN)
Exclusion criteria:
* Current or prior treatment with prandial or PreMix (70/30) insulin
* History of insulin pump use within 6 weeks of Visit 1
* Treatment with Glucagon-like Peptide (GLP-1) analog drugs within the preceding 12 weeks of Visit 1
* History of chronic obstructive pulmonary disease (COPD), asthma, or any other clinically important pulmonary disease (eg, pulmonary fibrosis)
* Any clinically significant radiological findings on screening chest x-ray
* Use of medications for asthma, COPD, or any other chronic respiratory conditions
* Evidence of serious complications of diabetes (eg, symptomatic autonomic neuropathy)
* Significant cardiovascular dysfunction or history within 3 months of Visit 1 (eg, congestive heart failure \[New York Heart Association {NYHA} Class III or IV\])
* Serious arrhythmia, myocardial infarction, cardiac surgery, recurrent syncope, transient ischemic attacks, or any cerebrovascular accident
* History of pulmonary embolism or deep venous thrombosis in the 12 months before Screening (Visit 1)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01196104
Study Brief:
Protocol Section:
NCT01196104