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 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT00523393
Eligibility Criteria:
Inclusion Criteria:
* Type 2 Diabetes
* Oral antidiabetic therapy
* Age 35 - 70
* 6,5%\< HbA1c ≤ 9%
* Ability of subject to understand character and individual consequences of clinical trial
* Written informed consent must be available before enrollment in the trial
* For women with childbearing potential, adequate contraception (Pearl Index \< 1%, e.g. birth control pill) and negative blood pregnancy test
* 6,5%\< HbA1c ≤ 9%
* Ability of subject to understand character and individual consequences of clinical trial
* Written informed consent must be available before enrollment in the trial
* For women with childbearing potential, adequate contraception (Pearl Index \< 1%, e.g. birth control pill) and negative blood pregnancy test
Exclusion Criteria:
* MODY
* Malignant disease
* Hematopoietic disorders
* Impairment of renal function (Serum creatinine \> 1,5mg/dl)
* autoimmune disease
* treatment with immunosuppressive drugs
* Psychiatric disease
* Myocardial ischemia during previous 6 month
* Acute coronary syndrome
* pAVK IIb, III, IV (Fontaine-Ratschow)
* Erythropoietin treatment
* Glitazone treatment during two weeks before inclusion
* Insulin treatment during two weeks before inclusion
* Pregnancy and lactation
* History of hypersensitivity to the investigational product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational product
* Participation in other clinical trials and observation period of competing trials, respectively
* No subject will be allowed to enroll in this trial more than once.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
70 Years
Study:
NCT00523393
Study Brief:
Protocol Section:
NCT00523393