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 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT01053234
Eligibility Criteria:
Inclusion Criteria:
* age 30-75 years
* BMI \> 25 kg/m2
* type 2 diabetes for more than 4 years
* pharmacological anti-diabetic treatment with insulin NPH at bedtime or insulin aspart at meals for more than 24 months
* metformin with stable dose \>1000 mg/d for more than 12 weeks
* acetylsalicylic acid (75 mg/d) for more than 2 weeks
* no other anti-diabetic treatment 3 month previously
* HbA1c\<8.5% at recruitment.
Exclusion Criteria:
* creatinine \> 120 µmol/l
* ALAT /ASAT \> 2.5 x upper reference limit
* use of anticoagulants within 1 month previously
* any changes in dose of statins within 1 month previously
* night work
* present or planned pregnancy
* mental sickness or alcohol abuse
* clinically relevant major organ or systemic illness
* uncontrolled hypertension \>180/110 mmHg
* steroid treatment
* known or suspected allergy to trial medications.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT01053234
Study Brief:
Protocol Section:
NCT01053234