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 @ 7:03 PM
Ignite Modification Date:
2025-12-24 @ 7:03 PM
NCT ID:
NCT01319357
Eligibility Criteria:
Inclusion criteria:
* Type 2 diabetes mellitus defined by fasting glucose ≥126 mg/dl or HbA1c ≥6.5% or on blood glucose lowering medication
* Age of 18 - 75 years
* Male and Female patients are eligible. Females of child bearing potential or within two years of the menopause are only eligible if pregnancy test at the screening visit is negative and they use adequate contraceptive precautions during the trial.
* The patient must demonstrate that she/he is able and willing to perform blood glucose measurements as necessary for Home Blood Glucose Monitoring by herself/himself after it was demonstrated to her/him.
Exclusion Criteria:
* Any other form of diabetes mellitus than type 2 diabetes mellitus
* Patients with more than on one blood glucose lowering medication or on insulin therapy
* Last measured HbA1c \> 11%
* Blood pressure levels ≥180/110 mmHg
* Body mass index \>50 kg/m²
* Triglyceride levels \>1000 mg/dl
* HDL-cholesterol levels \<25 mg/dl
* Estimated creatinine clearance \< 50 ml/min/1.73m²
* Macroalbuminuria defined by urinary albumine-to-creatinine ratio \> 300 mg/g
* Known liver function test \>3 times upper limit of normal
* Pregnant or breast-feeding patients
* Current or previous (within 6 months) treatment with an incretin-based therapy such as DPP 4 inhibitors and/or GLP-1 mimetics
* Any patient currently receiving chronic (\>30 consecutive days) treatment with an oral corticosteroid
* Acute cardiovascular event (including myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, heart failure, stroke, TIA. PRIND, intracerebral bleeding) \<6 months prior to screening visit (visit 1)
* Diabetic retinopathy
* History of epilepsia or history of seizures
* Patients being treated for severe auto immune disease e.g. lupus
* Involvement in the planning and/or conduct of the study (applies to both AstraZeneca and BMS or representative staff and/or staff at the study site)
* Previous randomisation in the present study
* Participation in another clinical study within 30 days prior to visit 1
* Individuals at risk for poor protocol or medication compliance
* Subject who do not give written consent, that pseudonymous data will be transferred in line with the duty of documentation and the duty of notification according to § 12 and § 13 GCP-V
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01319357
Study Brief:
Protocol Section:
NCT01319357