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 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT01768208
Eligibility Criteria:
Inclusion Criteria:
* All the subject Inclusion Criteria should be referred to STUDY: D168L00008.
Briefly
1. Provision of informed consent prior to any study specific procedures
2. Diagnosed with type 2 diabetes
3. Men or women who are 18 years of age.
4. Patients should be drug naïve or treated with metformin alone on stable doses of for at least continues 8 weeks.
5. HbA1c are between 7.5% and 11.0%
Exclusion Criteria:
* All the subject Exclusion Criteria should be referred to STUDY: D168L00008.
Briefly
1. Pregnant or breastfeeding patients.
2. Insulin therapy within one year of enrolment(with the exception of insulin therapy during a hospitalization or use in gestational diabetes).
3. Previous treatment with any dipeptidyl peptidase-IV (DPP-IV) inhibitors or Glucagon-like peptide-1 (GLP-1) analogue.
4. History of administration of any antihyperglycemic therapy (other than metformin) during the 8 weeks prior to Visit 1(12 weeks for previous TZD).
5. Treatment with systemic glucocorticoids other than replacement therapy. Inhaled,local injected and topical use of glucocorticoids is allowed.
6. Treatment with strong cytochrome P450 inhibitors.
7. Gastrointestinal surgery that could impact the absorption of study drug.
8. Contraindications to therapy as outlined in the saxagliptin package insert.
9. Hypersensitivity to saxagliptin
10. Have a history of, or currently have, acute or chronic pancreatitis.
11. Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma.
12. Any condition where, in the opinion of the investigator, participation in this study may pose a significant risk to the patient or could render the patient unable to successfully complete the study.
13. Fasting plasma glucose \>15mmol/l.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01768208
Study Brief:
Protocol Section:
NCT01768208