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 @ 4:18 PM
Ignite Modification Date:
2025-12-24 @ 4:18 PM
NCT ID:
NCT01722266
Eligibility Criteria:
Inclusion Criteria:
1. Patients with type 1 diabetes mellitus: Fasting c-peptide \< 0.1nmol/l on insulin therapy for more than 12 months with or without history of diabetic ketoacidosis.
2. Using a continuous glucose monitoring device (CGM) and regularly measuring their blood sugars four times daily
3. HbA1c of less than 8.5%.
4. Well versed with carbohydrate counting
5. Age 18-75 years
Exclusion Criteria:
1. Type 1 diabetes for less than 12 months;
2. Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks;
3. Hepatic disease (transaminase \> 3 times normal) or cirrhosis;
4. Renal impairment (serum creatinine \> 1.5);
5. HIV or Hepatitis C positive status;
6. Participation in any other concurrent clinical trial;
7. Any other life-threatening, non-cardiac disease;
8. Use of an investigational agent or therapeutic regimen within 30 days of study.
9. history of pancreatitis
10. pregnancy
11. inability to give informed consent
12. history of gastroparesis
13. history of medullary thyroid carcinoma or MEN 2 syndrome.
14. Family history of MEN 2, Family history of medullary thyroid cancer, or familial medullary thyroid cancer
15. Women of childbearing potential who are not using adequate contraception 16) Women who are pregnant
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01722266
Study Brief:
Protocol Section:
NCT01722266