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 @ 5:36 PM
Ignite Modification Date:
2025-12-24 @ 5:36 PM
NCT ID:
NCT02489968
Eligibility Criteria:
Inclusion criteria:
* Diagnosis of type 2 diabetes prior to informed consent
* Male and female patients on diet and exercise regimen for at least 12 weeks prior to informed consent who are:
* drug-naïve, defined as no antidiabetic drugs for at least 12 weeks prior to informed consent or,
* pre-treated with one oral antidiabetic drug (for sulfonylurea, with up to half of the maximum approved dose) on stable dosage for at least 12 weeks prior to the informed consent (for thiazolidinedione, therapy has to be unchanged for at least 18 weeks prior to the informed consent). Individual antidiabetic drug will have to be discontinued at Visit 1.
* haemoglobin A1c (HbA1c) at Visit 1 (screening)
* for patients without antidiabetic therapy : HbA1c \>=8.0 to =\<10.5%
* for patients with one oral antidiabetic drug : HbA1c \>=7.5 to =\<10.5%
* HbA1c \>=7.5 to =\<10.0% at Visit 4 for randomisation into the double blind treatment period
Exclusion criteria:
* Uncontrolled hyperglycaemia with a glucose level \>270 mg/dL (\>15.0 mmol/L) during the open label stabilisation period and placebo run in period
* Impaired renal function, defined as estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73m2 (modification of diet in renal disease (MDRD) formula)
* Acute coronary syndrome, stroke or transient ischemic attack (TIA) within 12 weeks prior to informed consent
* Indication of liver disease, defined by serum levels of either alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02489968
Study Brief:
Protocol Section:
NCT02489968