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 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT00698802
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes for at least 12 months
* Current biphasic human insulin (BHI) for at least 3 months - as monotherapy or as the only insulin in combination with OADs
* Body Mass Index (BMI) less than or equal to 40.0 kg/m2
* HbA1c less than or equal to 9.5%
* FPG (SMPG) less than or equal to 12 mmol/L
Exclusion Criteria:
* Treatment with more than 1IU/kg insulin daily
* Treatment with Glucagon-like peptide 1 mimetics or dipeptityl peptidase IV inhibitors
* Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator
* Known or suspected allergy to trial products or related products
* Receipt of any investigational drug within one month prior to this trial
* Any other condition that the Investigator feels would interfere with trial participation or evaluation of results, e.g. shiftworkers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00698802
Study Brief:
Protocol Section:
NCT00698802