A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Response, Multicentre, Multinational Study Evaluating the Efficacy and Safety of AVE2268 Administered Either Twice Daily (Breakfast and Lunch) at a Dose of 300, 600 and 1200 mg or Once Daily (Breakfast) at a Dose of 1200 mg, in Patients With Type 2 Diabetes Treated With Metformin and Not Adequately Controlled

CompletadoFase 2ClinicalTrials.gov

ID: NCT00361738Tipo: INTERVENTIONALInicio: 1 de jul de 2006Fin estimado: 1 de ene de 2008

Traducción no disponible, mostrando original

Resumen

Dose-ranging study of AVE2268 in the management of patients with type 2 diabetes mellitus also receiving metformin. Its main objectives will be to assess the effects of several doses of AVE2268 on Mean Plasma Glucose. Its secondary objectives will be to assess the effects of AVE2268 on plasma glucose (fasting and post-prandial), and also the safety and tolerability of AVE2268.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 74 YearsSexo: ALL

Criterios de inclusión

Type 2 diabetes mellitus, as defined by the American Diabetes Association, for at least one year at the time of screening.
HbA1c measured at visit 1 in the range of ≥ 7.0 and \< 9.0 %.
Stable metformin treatment (dose ≥ 1.5g/day for at least 3 months prior to enrollment in the study). No other antidiabetic medications are permitted for 3 months prior to enrollment.

Criterios de exclusión

Pregnant or breast-feeding women.
Women of childbearing potential not protected by medically approved contraceptive method of birth control.
BMI \>40kg/m2
Diabetes other than type 2 diabetes.
Subjects with "brittle-diabetes" or any hospitalization or emergency room visit due to poor diabetic control within the past 6 months, previous history of diabetes related dehydration leading to hospitalization, history or evidence of ketoacidosis.
Presence or history of cancer within the past five years.
Evidence within the past 6 months of myocardial infarction, stroke, retinopathy requiring laser surgery, or heart failure requiring hospitalization.
Impaired hepatic tests, impaired renal function.
History or evidence of clinically relevant renal or urological disorder.
The investigator will evaluate whether there are other reasons why a patient may not participate.

Intervenciones

drug

AVE2268

Ubicaciones

Sanofi-Aventis Administrative Office

San Isidro, Argentina

Patrocinadores

PrincipalSanofi

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