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 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 1:02 AM
NCT ID:
NCT01510093
Eligibility Criteria:
Inclusion Criteria:
* Subjects with type 2 diabetes mellitus
* Insulin-naive patients
* HbA1C \< 9%
* Women and men \>= 35 and \<= 75 years old
* BMI 25-42 kg/m2, both values are included
Exclusion Criteria:
* Suspected or known allergy to the trial drug or similar medications
* Treatment with hte drugs that after Investigator judgment could potentially interfere with plasma glucose levels
* Heart: Unstable angina pectoris, acute myocardial infarction within the last 12 months
* Severe uncontrolled hypertension with blood pressure in lying position \> 180/110 mmHg
* Impaired liver function with liver parameters more than 2 times above the upper normal limit according to the local laboratory
* Impaired kidney function with eGFR \< 50 ml/min according to the local laboratory
* Pregnancy, lactation or desire for pregnancy in the study period and for women in childbearing age without adequate contraception-adequate contraception is: sterilisation, hysterectomy or current use of contraceptive pills, coil, gestagen depot injection, subdermal implantation, hormonal vaginal ring and transdermal depot patch.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT01510093
Study Brief:
Protocol Section:
NCT01510093