NCT00272064|CompletedPhase 3
ELEONOR STUDY: Insulin Glulisine in Type 2 Diabetes Mellitus.
Optimisation of Insulin Treatment of Type 2 Diabetes Mellitus by Telecare Assistance for Self Monitoring of Blood Glucose (SMBG).
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Optimisation of Insulin Treatment of Type 2 Diabetes Mellitus by Telecare Assistance for Self Monitoring of Blood Glucose (SMBG).
Sponsor study identifier
Secondary identifiers
interventional
352
1 country
1
Study Start
October 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2008
Actual (reported)Study Completion
May 2008
Actual (reported)Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2005
Date type not reportedThis date has not been verified as actual or estimated.
January 2, 2006
Actual (reported)January 4, 2006
Actual (reported)May 2008
Actual (reported)May 2008
Actual (reported)Changes of glycosilated haemoglobin (HbA1c)
At least 12 weeks from baseline (visit 3)
Changes in fasting plasma glucose
At each visit
Changes in plasma insulin levels
At each visit
Change of Self-monitoring of Blood Glucose (SMBG)
for the total study duration
Mean Amplitude Glucose Excursion (MAGE)
for the total study duration
Change in lipid profile
V1 (screening) and V5 (end of treatment)
Telecare system
Self Monitoring Blood Glucose (SMBG)system.
individualized, once daily, dose aiming at 2h post-prandial plasma glucose goal \< 140 mg/dl (7.8 mmol/l) in the optimized treatment phase, since visit 3, subcutaneous
individualized, once daily, dose to reach mean fasting plasma glucose (FPG) \<= 126 mg/dl (7.0 mmol/l), since randomization, subcutaneous
Sanofi-Aventis Administrative Office
Milan, Italy
Del Prato S, Nicolucci A, Lovagnini-Scher AC, Turco S, Leotta S, Vespasiani G; ELEONOR Study Group. Telecare Provides comparable efficacy to conventional self-monitored blood glucose in patients with type 2 diabetes titrating one injection of insulin glulisine-the ELEONOR study. Diabetes Technol Ther. 2012 Feb;14(2):175-82. doi: 10.1089/dia.2011.0163. Epub 2011 Oct 20.
PAIZIS GEORGES, MD
Sanofi
352 participants (actual enrollment reported by the registry).
First Submitted
January 2, 2006
First Posted
January 4, 2006
Study Start
October 2005
Date type not reportedThis date has not been verified as actual or estimated.
Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes (LixiLan-India)
1000 mg b.i.d, since the qualification phase, oral
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
May 2008
Actual (reported)Study Completion
May 2008
Actual (reported)Last Updated
December 7, 2009
Record last verified: 2009-12
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Source: ClinicalTrials.gov.
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