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 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
NCT ID:
NCT01117350
Eligibility Criteria:
Inclusion criteria (comparative period):
* Patients With Type 2 Diabetes diagnosed for at least 1 year,
* Treated with lifestyle interventions and metformin at the maximum tolerated dosage (with a minimum daily dosage of 1g), either alone or in combination with an oral insulin secretagogue (sulfonylurea, glinide or DiPeptidyl Peptidase IV inhibitor), for more than 3 months,
* 7.5% \< HbA1c \<= 12%,
* Body Mass Index (BMI) between 25 and 40 kg/m2 inclusively,
* Ability and willingness to perform PG (Plasma Glucose) self monitoring using the sponsor-provided glucose meter and to complete the patient diary,
* Willingness and ability to comply with the study protocol,
* Signed informed consent obtained prior to any study procedure.
Inclusion criteria (extension period):
* Patients treated with liraglutide (at the maximal tolerated dosage), having a mean FPG ≥ 250 mg/dL at visit 10 (Week 12) or visit 11 (Week 18), or a HbA1c≥ 7% at visit 12 (Week 24)
* Dosage of metformin compliant with the inclusion criteria of visit 1 (i.e. maximum tolerated dosage, with a minimum daily dosage of 1g), and maintained stable during the comparative period.
Exclusion criteria:
* Previous treatment with Glucagon Like Peptide-1 analogues or insulin in the past year (except in case of temporary treatment for gestational diabetes, surgery, hospitalization...),
* Treatment with thiazolidinediones or α-Glucosidases inhibitors within 3 months prior to study entry,
* Diabetes other than Type 2 diabetes (e.g. secondary to pancreatic disorders, drug or chemical agents intake),
* Pregnant women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraceptive method),
* Lactating women,
* Hospitalized patients (except hospitalization for routine diabetes check-up),
* Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to study entry, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study, documented by a retina examination within 2 years prior to study entry,
* Impaired renal function (creatinine clearance \< 60 mL/mn),
* Impaired hepatic function (Alanine Aminotransferase, Aspartate Aminotransferase 2.5 times the upper limit of normal range),
* Personal or family history of medullary thyroid carcinoma,
* Multiple endocrine neoplasia syndrome type 2,
* Severe gastro-intestinal disease (including inflammatory bowel disease or diabetic gastroparesis),
* Congestive heart failure,
* History of acute pancreatitis,
* Treatment with corticosteroids with potential systemic action for more than 10 days within 3 months prior to study entry,
* Alcohol or drug abuse in the past 5 years,
* History of sensitivity to the study drugs or to drugs with a similar chemical structure.
* Night shift worker,
* Presence of any condition (medical, psychological, social or geographical), current or anticipated that would compromise the patients safety or limit the patient successful participation in the study,
* Participation in a clinical trial (drug or device) within 3 months prior to study entry,
* Refusal or inability to give informed consent to participate in the study,
* Patient is the Investigator or any sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
Additional exclusion criteria for the extension period:
* Treatment with oral antidiabetic drugs other than metformin and patient's usual sulfonylurea if any, or with insulin during the comparative period (except in case of an emergency, for a period of time less than 7 days),
* Treatment with corticosteroids with potential systemic action within the last 3 months of the comparative period.
* History of sensitivity to insulin glargine.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT01117350
Study Brief:
Protocol Section:
NCT01117350