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:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-26 @ 4:00 PM
NCT ID:
NCT01984606
Eligibility Criteria:
Inclusion criteria:
Inclusion criteria:
* Diagnosis of type 2 diabetes mellitus.
* Male and female patients on diet and exercise regimen who are:
* Treatment-naïve, defined as absence of any oral antidiabetic therapy for 12 weeks prior to randomisation.
or
* Pre-treated with immediate release metformin unchanged for 10 weeks prior to randomisation. Minimum dose for metformin: \>=1500 mg/day or maximum tolerated dose or maximum dose according to local label.
* HbA1c of \>= 7.5 % and \<= 10.5 % at Visit 1 and 3.
* Age \>= 18 yrs.
Exclusion criteria:
* Uncontrolled hyperglycaemia with a glucose level \>270 mg/dL (\>15 mmol/L) after an overnight fast during dose stabilisation (if applicable) and/or placebo run-in.
* Any other antidiabetic drug within 12 weeks prior to randomisation (applicable to treatment-naïve patients).
* Any other antidiabetic drug within 10 weeks prior to randomisation except metformin (applicable to patients on background treatment with metformin).
* Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent.
* Indication of liver disease.
* Moderate to severe renal impairment.
* Bariatric surgery within the past two years.
* Treatment with anti-obesity drugs 3 months prior to informed consent.
* Current treatment with systemic steroids at time of informed consent or any other uncontrolled endocrine disorder except type 2 diabetes mellitus.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01984606
Study Brief:
Protocol Section:
NCT01984606