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 @ 11:55 PM
Ignite Modification Date:
2025-12-24 @ 11:55 PM
NCT ID:
NCT01336751
Eligibility Criteria:
Inclusion Criteria:
* Patients must have given their signed informed consent.
* Males or females between 18 and 79 years of age.
* Diagnosis of type 2 diabetes mellitus for at least one year.
* Patients must have had continuous oral hypoglycemic treatment for at least three months using dosing of: at least half maximally labeled dose of sulfonylurea + at least 1000 mg metformin daily.
* HBA1C ≥ 8 % and ≤11 %, inclusive, as measured at screening (visit 1).
* Patients must have BMI of \> 25 kg/m2 at baseline
* Willingness to accept, and demonstrate ability to inject insulin glargine or 75% insulin lispro protamine suspension and 25% insulin lispro injection therapy.
* Ability and willingness to perform SMBG profiles using a plasma glucose meter at least twice a day.
* Patients must be able to understand and willing to adhere to and be compliant with the study protocol
Exclusion Criteria:
* Patients, who have had stroke, MI, coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris within the last 12 months.
* Patients with congestive heart failure requiring pharmacological treatment.
* Patients on non-selective beta blockers (including ocular).
* Patients with impaired renal function, as shown by but not limited to serum creatinine ≥ 1.5 mg/dl (133μmol/L) for males, or ≥ 1.4 mg/dl (124 μmol/L) for females.
* Patients with acute infections.
* Patients with diagnosis of dementia.
* Treatment with systemic steroids or large doses of inhaled steroids.
* Patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis.
* Patients with planned radiological examinations requiring administration of contrasting agents.
* Clinical evidence of active liver disease, or serum ALT 2.5 times the upper limit of the normal range.
* Patients with history of hypoglycemia unawareness.
* Pregnant or lactating females.
* Failure to use adequate contraception (women of current reproductive potential only).
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT01336751
Study Brief:
Protocol Section:
NCT01336751