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 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT01500850
Eligibility Criteria:
Inclusion Criteria:
* Give written informed consent.
* Patient consents that his/her family physician/diabetologist will be informed of trial participation
* Type-2 diabetes mellitus ≥ 1 year of diagnosis (male and female)
* Experienced in self blood glucose measurement for ≥ 3 months.
* HbA1c ≤ 9% and \>6,5%
* BMI \> 30 kg/m²
* Age ≥ 18 years
* Waist circumference \> 88 cm (female) and \> 102 cm (male)
* NPH insulin treatment plus 1 or 2 OAD (except TZD)
Exclusion Criteria:
* History of drug or alcohol abuse within the last five years prior to screening
* Anamnestic history of hypersensitivity to the study drugs (or any component of the study drug) or to drugs with similar chemical structures
* History of severe or multiple allergies
* Treatment with any other investigational drug within 3 months prior to screening
* Progressive fatal disease
* History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT \> 3 times the normal reference range), renal (creatinine \> 1.3 mg/dl in women and \>1.6 mg/dl in men), neurological, psychiatric and/or hematological disease as judged by the investigator
* Pregnant or lactating women
* Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomized partner
* Treatment with GLP1-analog or Thiazolidinediones (TZD)
* hsCRP \> 10 mg/l (by rapid test at screening visit).
* Lack of compliance or other similar reason that, according to investigator, precludes satisfactory participation in the study
* Type 1 Diabetes mellitus
* Patients already treated with intensified conventional insulin therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01500850
Study Brief:
Protocol Section:
NCT01500850