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INSULIN GLARGINE · TITRATION

Study of Two Titration Algorithms With Insulin Glargine 300 Units/mL in Type 2 Diabetes Mellitus Patients

Ensayo de Sanofi en Diabetes tipo 2.

Más ensayos de: Diabetes tipo 2.

Fase

Fase 3

Estado

Completado

Participantes

253

previstos

Centros

25

Fin del objetivo primario

feb 2016

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en mar 2015.

Qué mide

Percentage of patients reaching fasting SMPG ≤5.6 mmol/L without nocturnal (midnight to 6:00 am) hypoglycemia (confirmed or symptomatic or severe) (del registro, en inglés) (12 semanas)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objective: The primary objective of this study is to obtain efficacy and safety descriptive data on 2 different titration algorithms: the INSIGHT titration algorithm (self-titration of 1 unit/day) and the EDITION trial algorithm with insulin glargine 300 units/mL when given as basal insulin in uncontrolled type 2 diabetes mellitus (T2DM) patients on basal insulin with or without non-insulin anti-hyperglycemic agent (NIAHA) or in insulin naïve patients. Secondary Objective: The secondary objective is to gain additional efficacy and safety data (glycated hemoglobin \[A1C\], fasting plasma glucose \[FPG\], 7-point self-measure plasma glucose \[SMPG\], insulin dose and weight) and determine patient related outcome and health care professional satisfaction as it pertains to each titration regimen.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02401243), actualizada en mar 2016.