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 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT00807092
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes diagnosed for at least 6 months
* Insulin-naive (less than or equal to 1 week of daily use of insulin therapy)
* Treatment with metformin as monotherapy or in combination therapy with other OAD(s) for at least 3 months prior to this trial
* Currently on metformin greater than or equal to 1000 mg/day for at least 2 weeks
* Currently at least one of other OAD(s) reaching at least one-half of the recommended maximum dose for at least 2 weeks
* Glycosylated haemoglobin (HbA1c) between 7.5-11.0%
* Body Mass Index (BMI) between 18.5 - 35.0 kg/m\^2
* Be able and willing to perform continuous glucose monitoring system (CGMS ) and self-monitored blood glucose (SMBG)
Exclusion Criteria:
* Known or suspected allergy to trial product(s) or related products
* Any contraindication of metformin
* Receipt of investigational drug within the last 3 months prior to this trial
* Any history of chronic insulin therapy (more than 1 week of daily use)
* Systemically treated with thiazolidinediones (TZDs) for more than one month within 6 months prior to this trial
* Pregnancy, nursing mother, or unwillingness to use adequate contraception
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00807092
Study Brief:
Protocol Section:
NCT00807092