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 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT00747968
Eligibility Criteria:
Inclusion Criteria:
* Informed consent signed
* Caucasian
* Male
* Diabetes for \> 6 months
* Diet treatment or a single OAD (metformin, SU)
* Age \> 50 years and \< 70 years
* BMI 20-45 kg/m²
* Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 11% inclusive.
* Fasting PG 7-10 mmol/l
* OAD discontinued 72 hours prior to study day 1
Exclusion Criteria:
* Clinically significant liver- or kidney-disease (se-ALAT \> 2 times upper reference, or se-Creatinin \> 130 mM
* Anemia
* Other abnormal biochemical value
* Any of the following:
* Heart disease
* Liver disease
* Kidney disease
* Lung disease
* Gastro-intestinal disease
* Dyslipidemia (total serum-cholesterol \> 8 mmol/l, total cholesterol/HDL cholesterol ratio \> 8 or se-triglyceride \> 3.5 mmol/l)
* Endocrine disease (other than diabetes)
* CNS disease
* Hematological disease
* Loss of more than 100 ml blood within the latest month of inclusion
* Compliance problems
* Abuse of alcohol or drugs
* Smoking
* Participation in a clinical research study within 3 months of inclusion
* Allergy towards study hormones
* Medication with any drugs with effects on the glucose-metabolism, including \*glitazones
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Maximum Age:
70 Years
Study:
NCT00747968
Study Brief:
Protocol Section:
NCT00747968