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 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
NCT ID:
NCT01120912
Eligibility Criteria:
Inclusion Criteria:
* Stable type I diabetes mellitus.
* Male/female 18 years old and up.
* Glucose level is treated only by s.c basal/bolus insulin injection (not by insulin pump) at least 48 hours prior to study initiation.
* Patients must understand and be willing to give written informed consent prior to any study procedures or evaluations and be willing to adhere to all study schedules and requirements.
* Patients must be sterile or infertile or use an approved method of contraception from the time that the first dose of study medication is taken until three months following study completion or discontinuation.
Exclusion Criteria:
* Any history of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease which in the judgment of the investigator would interfere with the study or confound the results.
* Patients with positive HIV serology or positive HBsAg at screening.
* History or evidence of any active liver disease.
* C-peptide \> 3 mg/ml (fasting).
* Hba1c\<10.
* eGFR\>60.
* Female patients who are breastfeeding or have a positive pregnancy test at screening or at any time during the study.
* Inability to give written informed consent.
* History of alcohol or drug abuse within 6 months of screening.
* Patients who have a positive urine drug screen for substances of abuse (benzodiazepine, THC, opiates, amphetamines, cocaine) at the screening.
* Mental disorders.
* Patients with poor venous access.
* Significant swallowing disorders.
* Digestive disorders.
* Small bowel surgery.
* Mall absorption disorders.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01120912
Study Brief:
Protocol Section:
NCT01120912