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 @ 5:30 PM
Ignite Modification Date:
2025-12-24 @ 5:30 PM
NCT ID:
NCT01612468
Eligibility Criteria:
Inclusion Criteria:
* Type 1 diabetes according to WHO criteria ≥ 1 year
* Age ≥ 18 years
* BMI \> 25 kg/m2
* HbA1c \> 8.0 % at visit 0
Exclusion Criteria:
* Insulin pump treatment
* Hypoglycaemia unawareness (unability to register low blood glucose)
* Diabetic gastroparesis
* Compromised kidney function (eGFR \< 60 ml/min/1,73m2), dialysis or kidney transplantation at visit 0
* Liver disease with elevated plasma alanine aminotransferase (ALT) \> three times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)
* Acute or chronic pancreatitis
* Inflammatory bowel disease
* Cancer unless in complete remission for \> 5 years
* History of thyroid adenoma or carcinoma
* Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation
* Alcohol/drug abuse
* Fertile women not using contraceptives
* Pregnant or nursing women
* Known or suspected hypersensitivity to trial product or related products
* Receipt of an investigational drug within 30 days prior to visit 0
* Simultaneous participation in any other clinical intervention trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01612468
Study Brief:
Protocol Section:
NCT01612468