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:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 12:56 AM
NCT ID:
NCT01140893
Eligibility Criteria:
Inclusion Criteria:
* Men or women aged 35 to 70
* Type 2 diabetes diagnosed for at least 12 months, according the criteria of the American Diabetes Association :
* presence of classic symptoms of diabetes mellitus with unequivocal elevation of plasma glucose (2-hour post-prandial or random glucose \>200 mg/dL) or
* fasting plasma glucose elevation on more than 1 occasion \> 125 mg/dL or
* patient currently undergoing pharmacological and/or non-pharmacological treatment for diabetes mellitus
* CSII treatment using a rapid analog for at least 6 month (CSII being initiated in patients with HbA1c \> 8 % despite a well-conducted MDI trial using a 2 to 5 daily injection regimen)
* HbA1c ≥ 7,5% and ≤ 10 %
* BMI ≥ 25 and ≤ 45
* Stable body weight (≤10% variation) during the 3 last months
Exclusion Criteria:
* Type 1 diabetes assessed by positive anti-GAD65 or anti-insulin or anti-IA2 antibodies
* Monogenic diabetes (MODY, mitochondrial diabetes…)
* Current treatment with OHA (OHA ought to be interrupted at least two months prior to inclusion in the study)
* Current treatment specifically addressed for weight lost (orlistat, sibutramine, rimonabant may be interrupted at least 3 months prior to inclusion in the study)
* Use of corticosteroid therapy for more than 10 days within the 3-past months, or patient who ought to be treated by corticosteroid during the study period
* Clinically significant hepatic disease
* Documented gastroparesis, or current use of drugs that directly affect gastrointestinal motility, or any significant abdominal disease that may increase the risk of adverse gastrointestinal effects induced by exenatide
* Kidney failure (MDRD less than 50 ml/min)
* Pregnancy/breastfeeding
* Any social and/or mental condition rendering the subject unable to understand the scope and possible consequences of the study
* Concurrent enrolment in another clinical trial
* Geographically inaccessible for follow-up visits required by protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
70 Years
Study:
NCT01140893
Study Brief:
Protocol Section:
NCT01140893