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Insulin glargine · SAFIR

Insulin Analogue With Continuous Glucose Monitoring System (CGMS) Measurement

Ensayo de Sanofi en Diabetes Mellitus Type 2 (del registro, en inglés).

Fase

Fase 4

Estado

Completado

Participantes

480

previstos

Fin del objetivo primario

mar 2004

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en oct 2003.

Qué mide

Frequency of subjects with conventionally detected hypoglycemia (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary objective: Difference in frequency of subjects with conventionally detected hypoglycemia by the subject \[at least one measurement smaller/equal 60mg/dl documented in the 8-point profile in the case record form (CRF) or documentation of symptomatic hypoglycemia in the CRF through Visits 8/9\] compared to CGMS detected blood glucose values smaller/equal 60mg/dl during CGMS measurements (at least one measurement through Visits 8/9) after eight weeks of treatment with insulin glargine. Secondary objective: Secondary study objectives were to investigate the safety and efficacy of a treatment change to insulin glargine in ICT treated subjects in terms of: * Percentage of blood glucose measurements(CGMS data)smaller/equal 60mg/dl \[3.3 mmol/l\]. * Percentage of nocturnal blood glucose measurements(CGMS data)smaller/equal 60mg/dl\[3.3 mmol/l\]. * Percentage of daytime blood glucose measurements(CGMS data)smaller/equal 60mg/dl\[3.3 mmol/l\]. * Area under the curve (AUC smaller/equal 60)and time(t smaller/equal 60)for blood glucose smaller/equal 60mg/dl\[3.3mmol/l\], area under the curve (AUC greater/equal 180)and time (t greater/equal 180) for blood glucose greater/equal 180mg/dl\[10.0mmol/l\]. * Area under the curve (AUC smaller/equal 60)and time(t smaller/equal 60)for blood glucose smaller/equal 60mg/dl\[3.3mmol/l\]during the day (AUC 06.00am - 10.00pm)and during the night(AUC 10.00pm - 06.00am). * Area under the curve (AUC greater/equal 180)and time(t greater/equal 180)for blood glucose greater/equal 180mg/dl\[10.0mmol/l\]during the day (AUC 06.00am - 10.00pm)and during the night(AUC 10.00pm - 06.00am). * Frequency of subjects with nocturnal blood glucose value smaller/equal 60mg/dl\[3.3 mmol/l\]. * Frequency of subjects with asymptomatic nocturnal blood glucose smaller/equal 60mg/dl\[3.3 mmol/l\]. * Frequency of subjects with symptomatic nocturnal blood glucose smaller/equal 60mg/dl \[3.3 mmol/l\]. * Frequency of subjects with daytime blood glucose smaller/equal 60mg/dl \[3.3 mmol/l\]. * Frequency of subjects with asymptomatic daytime blood glucose smaller/equal 60mg/dl\[3.3 mmol/l\]. * Frequency of subjects with symptomatic daytime blood glucose smaller/equal 60mg/dl\[3.3 mmol/l\]. * Frequency of subjects with hyperglycemic blood glucose(greater/equal 180mg/dl,\[10.0mmol/l\]). * Frequency of subjects with symptomatic hypoglycemia(smaller/equal 60mg/dl \[3.3mmol\]). * Frequency of subjects with severe hypoglycemia(smaller/equal 36mg/dl \[2.0mmol/l\]). * Blood glucose values of 8-point profiles. * Mean daytime \& mean nocturnal blood glucose of 8-point-profiles. * HbA1c. * Fasting blood glucose (FBG). * Dose of insulin. * Adjustment of insulin. * Body weight, body mass index.

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Ficha completa en ClinicalTrials.gov (NCT00354939), actualizada en ago 2010.