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 @ 10:20 PM
Ignite Modification Date:
2025-12-24 @ 10:20 PM
NCT ID:
NCT01215435
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with type 2 diabetes for a minimum of 6 months prior to Visit 1
* HbA1c at least 7.0 % - maximum 11 % at screening
* Subject is insulin naïve (short-term insulin treatment of up to 14 days is allowed)
* An antidiabetic regimen that has been stable for at least 3 months prior to screening
* An antidiabetic regimen that includes a minimum of 2 OADs
* OADs dosed at least 50% of the maximum recommended dose
Exclusion Criteria:
* Known or suspected hypersensitivity to trial product(s) or related products
* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
* The receipt of any investigational medicinal product within one month prior to this trial
* Suffer from a life threatening disease (cancer)
* Cardiac disease: class III or IV congestive heart failure (CHF), unstable angina, and or any myocardial infarction (treated or untreated) within 6 months prior to screening
* Hepatic insufficiency (Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) above 2 times the central laboratory's upper reference limit)
* Renal insufficiency (serum creatinine above 1.6 mg/dl for males; 1.4 mg/dl for females
* Recurrent hypoglycaemia or hypoglycaemic unawareness
* Anemia (haemoglobin below 10 mg/dl)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01215435
Study Brief:
Protocol Section:
NCT01215435