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 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT00690456
Eligibility Criteria:
Inclusion Criteria:
* History of type 2 diabetes
* HbA1c between 7% to 10% at screening visit
* Treatment with metformin only with a fixed and stable dose of 1500 mg/day or more for at least the past 3 months prior to screening visit
Exclusion Criteria:
* Within 3 months prior to screening visit: change in lipid modifying agent, administration of systemic corticosteroids for more than 10 days, use of any anti-obesity agent or drugs for weight loss
* Weight loss of more than 5 kg within 3 months prior to screening
* Administration of other investigational drugs within 30 days prior to screening visit
* Prior exposure to type 1 cannabinoid receptor (CB1) antagonists including rimonabant
* Presence or history of cancer within the past five years
* Pregnant or breast-feeding women
* Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation including uncontrolled serious psychiatric illness such a major depression within the last 2 years, and history of other severe psychiatric disorders.
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
Study:
NCT00690456
Study Brief:
Protocol Section:
NCT00690456