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 @ 7:14 PM
Ignite Modification Date:
2025-12-24 @ 7:14 PM
NCT ID:
NCT00851903
Eligibility Criteria:
Inclusion criteria:
* Patients who completed the core study LANTU\_C\_02761 (NCT00751114) i.e. went through the visit 14 investigation,
* HbA1c \>= 7 %,
* Dose of metformin compliant with the inclusion criteria of the core study (i.e. at least 1 g/day), and maintained stable for the duration of the core study
* Ability and willingness to perform plasma blood glucose monitoring using the sponsor-provided plasma glucose meter and to complete the patient dairy,
* Signed informed consent obtained prior any study procedure,
* Willingness and ability to comply with the study protocol.
Exclusion Criteria:
* Treatment with oral antidiabetic drugs other than metformin and sitagliptin in the core study,
* Treatment with insulin other than Insulin Glargine in the core study (except in case of an emergency, for a period of time less than 7 days),
* Treatment with a non-permitted drug during the core study,
* Pregnant or lactating women,
* In-patient care,
* Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study (an optic fundus examination should have been performed within the 2 years prior to study entry in the core study),
* Impaired renal function: serum creatinine \>= 1.5 mg/dL (\>= 133µmol/L) or \>= 1.4 mg/dL (\>=124 µmol/L) in men and women, respectively,
* History of sensitivity to the study drugs or to drugs with a similar chemical structure,
* Impaired hepatic function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) \> 3 x upper limit of normal range,
* Alcohol or drug abuse within the last year,
* Night shift worker,
* Presence of any condition (medical, psychological, social or geographical), current or anticipated that the investigator feels would compromise the patient's safety or limit the patient successful participation in the study,
* Treatment with weight loss medications (e.g. sibutramine, orlistat, rimonabant),
* History of pancreatitis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
71 Years
Study:
NCT00851903
Study Brief:
Protocol Section:
NCT00851903