A Randomized, Double-Blind, Parallel-Group, Multicenter, Multinational Study to Assess Glycemic Control with Rimonabant in Comparison with Glimepiride over 1 Year in Overweight/Obese Type 2 Diabetic Patients Not Adequately Controlled with Metformin - ALLEGRO

sanofi-aventis recherche et developpement0 个研究点目标入组 500 人开始时间: 2007年8月24日最近更新: 2012年3月19日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: sanofi-aventis recherche et developpement
入组人数: 500

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•Male or female patients with legal age. - BMI > 27 kg/m². - Type 2 diabetes as defined by WHO criteria (26) (diagnosis was based on fasting venous plasma glucose concentration > or equal 7.0 mmol/L or 2-h post-glucose load venous plasma glucose > or equal 11.1 mmol/L) only treated with metformin for at least 6 months and with a stable dose of metformin > or equal 1500 mg/day for at least three months. - HbA1c > or equal 7% and > or equal 9% at screening Visit. - Patients able to perform self monitoring blood glucose as confirmed at baseline Visit
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

排除标准

•Exclusion criteria relating to methodology - Weight loss > 5 kg within three months prior to screening Visit. - Patients with conditions/concomitant diseases making them non evaluable for the efficacy assessment: - Presence of any clinically significant endocrine disease according to the Investigator (euthyroid patients on replacement therapy will be included if the dosage of thyroxine is stable for at least 3 months prior to screening Visit). - Presence of type 1 diabetes. - Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the patient's safety or successful participation in the study. - Presence or history of cancer within the past five years with the exception of adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer. - Previous participation in a clinical study with rimonabant. - History of previous treatment with sulphonylurea(s). NB: This previous treatment will be allowed if there was no prescription of a sulphonylurea within 1 year prior to screening visit and the duration was less than 3 months. Cessation of this treatment should not have been linked to safety purpose. - Administration of other investigational drugs within 30 days prior to screening Visit. - Absence of effective medical contraceptive method for females of childbearing potential. - Related to previous or concomitant medications that could bias evaluation of primary and secondary endpoints: - Within 6 months prior to screening Visit and/or between the screening and the baseline Visits: - Administration of any oral antidiabetic drugs other than metformin (i.e.; metiglinides, thiazolidinediones, alpha-glucosidase inhibitors, DPP-a inhibitors, GLP-1 agonists) and/or insulin (for sulphonylurea treatment see above). - Within 3 months prior to screening Visit and/or between the screening and the baseline Visits: - Administration of anti-obesity drugs (sibutramine, orlistat). - Administration of other drugs for weight reduction (e.g., phentermine, amphetamines). - Administration of thyroid preparations or thyroxine (except in patients on stable replacement therapy). - Within 2 months prior to screening Visit and/or between the screening and the baseline Visits: - Administration of systemic long-acting corticosteroids. - Prolonged use (more than one week) of other systemic corticosteroids. - Change in the lipid lowering treatment. - Within 30 days prior to screening Visit and/or between the screening and the baseline Visits: - Administration of herbal preparations for weight reduction - Related to laboratory findings: - Endogeneous insulin production as measured by a fasting C-peptide < 1.0 ng/mL. - Abnormal serum thyrotropin (TSH) levels at screening Visit. - Positive test for hepatitis B surface antigen and/or hepatitis C antibody at screening Visit. - Positive urine pregnancy test in females of childbearing potential at screening and baseline Visits. - Any relevant abnormality interfering with the efficacy or the safety assessments during the study drug administration. - Patients considered by the Investigator unsuitable candidates to receive an investigational drug. - Refusal or inability to give informed consent to participate to the study. - Presence of any other condition (e.g. geographic, social…) actual or anticipated, that the Investigator feels, would restrict or limit the patient's participation for the duration of the study. Exc

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发起方

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