Efficacy Study on the Control of Blood Glucose Concentration in Type 1 Diabetic Patients (VARIABILITE)
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|ClinicalTrials.gov Identifier: NCT00271284|
Recruitment Status : Completed
First Posted : December 30, 2005
Last Update Posted : December 7, 2009
·Main objective: To compare the variability of fasting capillary blood glucose concentration, observed with insulin glargine combined with insulin glulisine and with insulin detemir combined with insulin glulisine, in type 1 diabetics. It is a non-inferiority study.
- To compare the variability of blood glucose concentration before the evening meal, observed with insulin glargine combined with insulin glulisine and with insulin detemir combined with insulin glulisine, in type 1 diabetics.
- To record the intra- and inter-daily variability using the MAGE and MODD indices [1,2,3,4]
- To compare the glycaemic profiles (7 points)
- To evaluate the HbA1c concentration, at the end of each period of treatment, weight change, the dose of insulin used and the number of daily injections.
- To record undesirable events
- To evaluate the safety in use from the record of episodes of hypoglycaemia (symptomatic, diurnal, nocturnal, severe).
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Drug: insulin glulisine / insulin glargine Drug: insulin glulisin / insulin detemir||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||88 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Crossover, Multicentre, Randomised Trial Comparing the Effect on the Control of Blood Glucose Concentration of Insulin Glargine and Insulin Detemir, Combined With Insulin Glulisine, Used as a Bolus, in Type 1 Diabetic Patients|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2008|
Drug: insulin glulisine / insulin glargine
insulin glargine administered subcutaneously by the patient once a day, in the evening, between 18.30 and 24.00
|Active Comparator: II||
Drug: insulin glulisin / insulin detemir
insulin detemir administered subcutaneously by the patient once a day, in the evening, between 18.30 and 24.00
- Efficacy data : fasting blood glucose concentration [ Time Frame: read daily during the last 2 months of each period ]
- Tolerance data : undesirable events including episodes of hypoglycaemia [ Time Frame: throughout the study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00271284
|Sanofi-Aventis Administrative Office|
|Study Director:||Marie SEBILLE, Dr||Sanofi|