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 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT01719003
Eligibility Criteria:
Inclusion criteria:
1. Diagnosis of type 2 diabetes mellitus prior to informed consent
2. Male and female patients on diet and exercise regimen who are drug-naive, defined as absence of any oral antidiabetic therapy for 12 weeks prior to randomization
3. HbA1c \>=7.5% and \<= 12% (\>=58.5 mmol/mol and \<=107.7 mmol/mol)
4. Body Mass Index (BMI) \<= 45 kg/m2 at screening
Exclusion criteria:
1. Uncontrolled hyperglycemia with a glucose level \>240 mg/dl (\>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second laboratory measurement (not on the same day)
2. Any antidiabetic drug within 12 weeks prior to randomization
3. Impaired renal function, defined as estimated creatinine clearance rate (eCCr) \<60 ml/min (Cockcroft-Gault formula) as determined during screening and/or run-in period
4. Contraindications to metformin according to the local label
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01719003
Study Brief:
Protocol Section:
NCT01719003