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 @ 4:28 AM
Ignite Modification Date:
2025-12-25 @ 4:28 AM
NCT ID:
NCT00605020
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes
* Duration of type 2 diabetes for at least 6 months since diagnosis
* Current treatment with one or two oral antidiabetic drugs for at least 3 months or with one or two oral antidiabetic drugs, given for at least 3 months in combination with intermediate or long-acting insulin/insulin analogue once daily
* BMI below 40 kg/m2
* HbA1c between 7-12%
* Able and willing to perform self-monitoring of capillary blood glucose
Exclusion Criteria:
* Current antidiabetic treatment with combination of three or more oral antidiabetic drugs
* Previous treatment with short-acting human insulin, short-acting insulin analogue or biphasic insulin/insulin analogue within the last 6 months (7 days or less within the last 6 months is allowed)
* Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator
* Known or suspected allergy to trial product or related products
* Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures
* Receipt of any investigational drug within 4 weeks prior to this trial
* Previous participation in this trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00605020
Study Brief:
Protocol Section:
NCT00605020