Eligibility Module

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 @ 12:43 AM
Ignite Modification Date: 2025-12-25 @ 12:43 AM
NCT ID: NCT02111967
Eligibility Criteria: Inclusion Criteria: * Diagnosis of T2DM \> 6 months * Metformin treatment for at least 6 months * Age \> 18 years * Ability to give written informed consent * No metformin treatment in the last 6 months (control group) Exclusion Criteria: * Concurrent intake of preparations containing VB12 (within the last 3 months prior to study participation) * Lack of written and/or oral understanding in German, French, Italian or English languages * Diagnosis of Transcobolamin transporter defect * Diagnosis of Chronic or acute liver diseaseliver insufficiency with CHILD-PUGH scores B and C and acute hepatitis * Diagnosis of Renal disease (Creatinine-Clearance \<60 ml/min)renal insufficiency stadium III, IV and V (KDOQI) and acute renal diseases
Healthy Volunteers: False
Sex: ALL
Minimum Age: 18 Years
Study: NCT02111967
Study Brief:
Protocol Section: NCT02111967