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5月30日最近更新: 2012年3月19日

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 = 7.0 mmol/L or 2-h post-glucose load venous plasma glucose = 11.1 mmol/L) only treated with metformin for at a stable dose of metformin = 1500 mg/day for at least three months.
•- HbA1c = 7% and = 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 three 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, including uncontrolled serious psychiatric illness such as major depression, suicidal ideation and medical history of suicide attempt.
•- 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 3 months prior to screening Visit and/or between the screening and the baseline Visits:
•- Administration of any 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).
•- 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.
•N.B.: Optimal dosing for lipid lowering therapies (if any) should be achieved at least 2 months prior to screening and therefore, changes in lipid-lowering therapies or doses are discouraged after screening. However, changes can be made if clinically indicated. If such a change in lipid-lowering therapies is expected/planned at the time of the screening Visit (or prior to the baseline Visit), the patient should not be randomized.
•- 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 s

研究者

发起方

sanofi-aventis recherche et developpement

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