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 @ 2:02 PM
Ignite Modification Date:
2025-12-24 @ 2:02 PM
NCT ID:
NCT01137695
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-80 years.
2. Type 2 diabetes mellitus.
3. Obese (BMI \> 30 kg/m2), waist circ. \>35" women, \>40" men.
4. Basal insulin plus at least 2 injections of mealtime insulin daily or pre-mixed insulin.
5. On stable insulin dose for at least 3 mos (baseline + 20%, no minimum).
6. If pramlintide treated, on stable full dose for at least 3 months.
7. A1c \> 7.0% and \< 9.0%.
8. Women of childbearing age if using a reliable form of birth control.
9. Women of childbearing age if post tubal ligation or surgical menopause.
10. Able to consent.
11. Willing to perform self-monitoring of glucose.
12. Willing to attend study visits.
13. Written informed consent to participate in the study.
14. Agreement to maintain prior diet and exercise throughout the full course of the study.
Exclusion Criteria:
1. Age \<18 or \>80 years.
2. Confirmed gastroparesis or taking medications affecting gastric motility.
3. A1c \<7.0% or \>9.0%.
4. Recurrent severe hypoglycemia or hypoglycemic unawareness.
5. CHF.
6. Creatinine clearance \<30 ml/min.
7. History of MI \<6 mos prior to enrollment.
8. History of ventricular arrhythmia.
9. History of cancer or chemotherapy \<6 mos prior to enrollment.
10. Laboratory abnormalities as follows:
1. Liver enzymes \>3X ULN.
2. Hematocrit less than 30.
3. Serum creatinine \>2.5 mg/dl.
4. Fasting triglycerides \>500 mg/dl.
11. Cirrhosis.
12. Pregnancy or nursing.
13. Inability to provide consent.
14. Unwilling to attend study visits.
15. Unwilling to perform self-monitoring of glucose.
16. Chronic oral or parenteral glucocorticoid therapy (over one week of treatment) within 3 months prior to screening.
17. Investigational drug treatment within 3 months prior to screening.
18. Donation of blood, significant blood loss or transfusion within 3 months of screening.
19. History of acromegaly or Cushing's syndrome.
20. Use of prohibited concomitant medications.
21. Type 1 diabetes mellitus.
22. Acute metabolic complication (hyperosmolar state) \<6 months prior to screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01137695
Study Brief:
Protocol Section:
NCT01137695