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:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT00651105
Eligibility Criteria:
Inclusion Criteria:
Inclusion criteria - Type-2 Diabetes Patients
* Male or female patients aged 30 to 75 years with Type-2 Diabetes Mellitus (T2DM) and who are in otherwise good health
* Must have been diagnosed with T2DM at least 6 months prior to screening, and whose diabetes is controlled by diet and exercise alone or by stable dosage ( \> 3 months) of metformin
* HbA1c in the range of 6.5% to 9% at screening
Inclusion Criteria - Healthy Volunteers
* Male or female subjects aged 30 to 75 years, determined to be in good health
* Normal oral glucose tolerance test (OGTT) at screening
* Age, gender and weight matched to subjects with T2DM
Exclusion Criteria:
Exclusion criteria - Type-2 Diabetes Patients
* A history of:
* Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly
* Acute metabolic diabetic complications (such as ketoacidosis or hyperosmolar state (coma)) within the past 6 months
* Torsades de Pointes, ventricular tachycardia or ventricular fibrillation
* Any severe hypoglycemic episode within 3 months of screening
* Use of any of the following medications:
* Antihypertensive or lipid-lowering agents unless on a stable dose for at least 3 months prior to screening
* Chronic insulin treatment (\> 4 weeks of treatment in the absence of an intercurrent illness) within the past 6 months
* Chronic oral/intramuscular/intravenous corticosteroid treatment ( \> 7 consecutive days of treatment) within 8 weeks prior to screening
Exclusion Criteria - Healthy Volunteers
* First degree relative of an individual with T2DM
* History of gestational diabetes
* Use of any prescription medication within 1 month prior to dosing. Use of over-the-counter medications or vitamins within 14 days prior to dosing.
Other protocol-defined inclusion/exclusion criteria may apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT00651105
Study Brief:
Protocol Section:
NCT00651105