Conceptio › Archive › ClinicalTrials.gov
ClinicalTrials.gov public full text Public Domain

Insulin Analogue With Continuous Glucose Monitoring System (CGMS) Measurement

Sanofi · 2003
ClinicalTrials.gov · Datasets · License: Public Domain · 2003
Open Source ↗
Primary 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/e
Conceptio Open Archive

Analyze & explore related research in Conceptio

Connect this record directly into your research workflow or AI agent. Explore citations across open repositories, query full text, and export structured proof bundles.

This document is indexed with metadata only: full text is not available in the archive for this record. Open the official source ↗

Related documents

Record · ID 1101985
Retrieved via Conceptio: every document is proof-bundled with source, license, and retrieval metadata.
Bring this data into your agent: Connect via MCP or API · 20 free credits to start · no card required
Read the Docs → · View CLI source on GitHub · Conceptio Open Knowledge Archive