To evaluate the efficacy of a single injection of glulisine before the main meal added to insulin glargine plus oral antidiabetic drugs (OADs) compared to insulin glargine plus OADs in Type 2 diabetic patients poorly controlled with basal insulin plus OADs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
106
One daily injection at bedtime
At same dosage as during the run-in period
One bolus given before the main meal
Sanofi-aventis
Bridgewater, New Jersey, United States
Sanofi-Aventis
Moscow, Russia
Sanofi-aventis
Guildford, United Kingdom
Patients With Glycosylated Haemoglobin (HbA1c) Value < 7%
Glycosylated Haemoglobin (HbA1c) is a biological parameter that reflects the blood glucose concentration over a long period of time. It is the standard parameter for glycemic control follow -up in diabetic patients. this parameter is expressed in percentage (%) and the target in diabetes management is to reach a HbA1c \<7%
Time frame: at the end of treatment (week 24)
Glycosylated Haemoglobin (HbA1c) Value
Time frame: at the end of treatment (week 24)
Change in Glycosylated Haemoglobin (HbA1c) Value
Time frame: from baseline to the end of treatment (week 24)
Daily Mean Plasma Glucose
Time frame: at the end of treatment (week 24)
Change in Daily Mean Plasma Glucose
Time frame: from baseline to the end of treatment (week 24)
Change in Weight
Time frame: from baseline to the end of treatment (week 24)
Daily Dose of Insulin Glargine
Mean of 3 daily doses reported during the week prior to the final visit
Time frame: at the end of treatment (week 24)
Daily Dose of Insulin Glulisine
Mean of 3 daily doses reported during the week prior to the final visit
Time frame: at the end of treatment (week 24)
Rate of Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL
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At same dosage as during the run-in period
Time frame: during treatment period (12 weeks)
Rate of Nocturnal Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL
Time frame: during treatment period (12 weeks)
Rate of Severe Symptomatic Hypoglycemia
Time frame: during treatment period (12 weeks)