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Ranolazine

Exploratory Study to Access the Metabolic Effects of Ranolazine in Subjects With Type 2 Diabetes Mellitus When Added to Ongoing Non-insulin Antidiabetic Therapy

Ensayo de GILEAD SCIENCES, INC. en Diabetes tipo 2.

Más ensayos de: Diabetes tipo 2.

Fase

Fase 2

Estado

Completado

Participantes

80

previstos

Centros

9

Fin del objetivo primario

nov 2010

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en jun 2010.

Qué mide

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 (del registro, en inglés) (del inicio a la semana 12)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis study enrolled participants with inadequately controlled type 2 diabetes mellitus (T2DM) despite non-insulin antidiabetic therapy in addition to diet and exercise, and would have benefited from additional control of blood glucose levels. The study assessed the metabolic effects of ranolazine, including its effect in lowering glycosylated hemoglobin A1c (HbA1c), and lowering glucose while fasting, and following a meal (postprandial). Participants were randomized in a 1:1 ratio to receive ranolazine or placebo, and were stratified by HbA1c ≤ 7.5% or \> 7.5%. Enrollment was to include no more than two-thirds of participants with baseline HbA1c ≤ 7.5%. Other than glucose values, efficacy endpoint results remained blinded during the study; for safety purposes, the investigator was to be alerted of severe hyperglycemia or hypoglycemia. Participants were instructed to maintain logs of their physical activity/exercise (Subject Activity Assessment) and study drug dosing (Dosing Log).

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Todos los de GILD, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01163721), actualizada en jul 2013.