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 @ 5:43 PM
Ignite Modification Date:
2025-12-24 @ 5:43 PM
NCT ID:
NCT01011868
Eligibility Criteria:
Inclusion criteria:
1. Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation
2. Male and female patients with a diagnosis of Type 2 Diabetes Mellitus treated with a stable dose of basal insulin with or without concomitant metformin and / or sulfonylurea.
3. Glycosylated hemoglobin A1c (Type A, subtype 1c) of \>7.0% and \< or = 10% at Visit 1 (screening)
4. Suitability for trial participation according to investigator's judgment (evaluating all alternative treatment options and in consideration of the patient completing the study)
5. Age \> or =18 years at Visit 1 (screening)
6. BMI \< or = 45 kg/m2 (Body Mass Index) at Visit 1 (screening)
Exclusion criteria:
1. Patients with poorly controlled hyperglycemia
2. Frequent (at the discretion of the investigator) episodes of hypoglycemic events on basal insulin therapy
3. MI, stroke, or TIA within 3 months prior to obtaining informed consent
4. Impaired hepatic or renal function; gastric surgery; cancer within the last 5 years; blood dyscrasias
6\. Treatment with other anti-diabetics, anti-obesity medications, steroids or thyroid hormones, participation in another trial with an investigational drug 7. Pre-menopausal women on insufficient birth control 8. Alcohol or drug abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01011868
Study Brief:
Protocol Section:
NCT01011868