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:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT01272193
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
* HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis
* Body Mass Index (BMI) below or equal to 35.0 kg/m\^2
* Insulin naive subject and ongoing treatment with 1 or more oral antidiabetic drugs (OADs) for at least 12 weeks prior to randomisation with at least recommended maintenance dose according to local, approved labelling Allowed are: a. Previous short term insulin treatment up to 14 days; b. Treatment during hospitalization or during gestational diabetes is allowed for periods longer than 14 days)
Exclusion Criteria:
* Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, mono amino oxidase (MAO) inhibitors
* Use of glucagon-like peptide-1 (GLP-1) receptor agonists, buformine and/or rosiglitazone within the last 12 weeks prior to randomisation
* Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01272193
Study Brief:
Protocol Section:
NCT01272193