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 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT02987751
Eligibility Criteria:
Inclusion Criteria:
1. Insulin naïve men and women with T2DM on stable dose of 2 or 3 OHAs for at least 3 months.
2. Both men and women of age ≥ 18 and ≤ 65 years.
3. Have an HbA1c ≥ 7.5% and ≤ 10.5% with fasting blood glucose ≥ 150 mg/dl, and/or Postprandial blood glucose ≥ 200 mg/dl
4. Body mass index (BMI) ≤ 40 kg/m2.
5. Have given written informed consent to participate in this study in accordance with local regulations.
6. Subject must have access to telephone for calling into the clinical center as part of test product compliance.
Exclusion Criteria:
1. Type 1 diabetes
2. BMI \> 40 kg/m2
3. Subject is being treated for severe active infection of any type
4. Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study.
5. Planned surgery in the next 6 months
6. Any event forecasted to require a temporary need to switch to insulin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02987751
Study Brief:
Protocol Section:
NCT02987751