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 @ 1:19 PM
Ignite Modification Date:
2025-12-24 @ 1:19 PM
NCT ID:
NCT02315495
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes (World Health Organisation (WHO) criteria), managed by diet alone (i.e. no oral hypoglycaemic drugs or insulin)
* Body mass index (BMI) 20 - 40 kg/m2
* Age 18 - 70 years
* Males and post-menopausal females (to control for the effect of the menstrual cycle on gut hormone secretion)
* Glycated haemoglobin A1c (HbA1c) ≥ 6.0% and ≤ 7.9%
* Haemoglobin above the lower limit of the normal range (i.e. \>135g/L for men and 115g/L for women), and ferritin above the lower limit of normal (i.e. \>10mcg/L)
Exclusion Criteria:
* Use of any medication that may influence gastrointestinal motor function, body weight or appetite
* Evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes on a daily basis
* History of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms, pancreatitis, or previous gastrointestinal surgery (other than uncomplicated appendicectomy or cholecystectomy)
* Other significant illness, including epilepsy, cardiovascular or respiratory disease
* Autonomic nerve damage (as assessed by standardised cardiovascular reflex tests \[36\])
* Impaired renal or liver function (as assessed by calculated creatinine clearance \< 90 mL/min or abnormal liver function tests (\> 2 times upper limit of normal range))
* Allergy to vildagliptin or any other 'gliptin'
* Donation of blood within the previous 3 months
* Participation in any other research studies within the previous 3 months
* Females who are pre-menopausal
* Inability to give informed consent
* Vegetarians
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02315495
Study Brief:
Protocol Section:
NCT02315495