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 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
NCT ID:
NCT00668850
Eligibility Criteria:
Inclusion Criteria:
* Be male or female between the ages 18 to 75 years
* Type 1 diabetes mellitus patients (according to ADA and/or WHO classification) who have \>1 year history of type 1 DM and are currently managed with daily insulin injections totalling 0.3 to 0.8 IU/kg of body weight;
* Current physical examination, vital signs and ECG at screening that reveals no clinically significant abnormalities;
* Have a body mass index (BMI) \<27;
* 8.5% (inclusively)\<Have a glycosylated haemoglobulin HbA1c
* Willing and able to follow the American Diabetes Association diet guidelines for type 1 diabetes; be able to commit to perform home blood glucose monitoring and record values as well as hypoglycemic events
* Willing to give written informed consent prior to admission into the study.
Exclusion Criteria:
* Have a significant active asthma or suspected abnormalities of buccal mucosa; cardiovascular, cerebrovascular, hepatic, renal, gastrointestinal, hematological, or auto-immune disease (other than auto-immune thyroid disease); history of athopy or drugs allergy
* Have evidence of unstable retinopathy (defined as pre-proliferative or proliferative retinopathy currently requiring photocoagulation therapy), nephropathy or neuropathy (gastroparesis or orthostatic hypotension);
* Have hypoglycemia unawareness;
* Have had more than one episode of severe hypoglycemia with seizure or coma or ketoacidosis within the past 12 months;
* Have a blood pressure in excess of 160/100 mmHg at the Screening visit;
* Have had any acute illness within the 2 weeks prior to screening;
* Have a history of drug or alcohol abuse that in the opinion of the Investigator would interfere with participation in the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00668850
Study Brief:
Protocol Section:
NCT00668850