Apidra (insulin glulisine) - Sanofi Canada

glargine followed by randomization. Glycemic control and the rates of hypoglycemia requiring
intervention from a third party were comparable for the two treatment regimens. The number of
daily insulin injections and the total daily doses of APIDRA and insulin lispro were similar. The
decrease in A1c was observed in patients treated with APIDRA without an increase in the basal
insulin dose (see Table 8).
Table 8: Type 1 Diabetes Mellitus–Adult
Treatment duration
Treatment in combination with following basal
26 weeks
LANTUS
insulin:
®
(insulin glargine)
APIDRA Insulin lispro
Number of subjects treated
A1c (%)
339 333
Endstudy mean 7.46 7.45
Adjusted mean change from baseline -0.14 -0.14
APIDRA – Insulin lispro 0.00
95% CI for treatment difference
Basal insulin dose (U/day)
(-0.09; 0.10)
Endstudy mean 24.16 26.43
Adjusted mean change from baseline
Short-acting insulin dose (U/day)
0.12 1.82
Endstudy mean 29.03 30.12
Adjusted mean change from baseline
Severe hypoglycemia*
-1.07 -0.81
Number of subjects (%) 16/335 (4.8) 13/326(4.0)
Rate (events/month/patient) 0.02 0.02
Mean number of short-acting insulin injections per
3.36 3.42
day
* Events requiring assistance from third party during the last 3 months of the study
CI = Confidence Interval
Type 1 Diabetes-Pediatric:
A 26-week phase III open-label, active controlled study (n=572) evaluated the efficacy and
safety of APIDRA in children and adolescents with type I diabetes mellitus, in comparison with
insulin lispro when administered subcutaneously within 15 minutes before a meal. LANTUS
(insulin glargine) was administered once daily in the evening or NPH twice daily in the morning
and in the evening as basal insulin. The study consisted of a 4-week run-in phase during which
patients received NPH or insulin glargine combined with insulin lispro, followed by a 26-week
treatment-phase comparing insulin glulisine and insulin lispro, given at least twice daily
within15 minutes prior to a meal in combination with NPH insulin administered twice daily or
insulin glargine administered once daily in the evening. Most patients were Caucasian (91%).
Fifty percent of the patients were male. The mean age was 12.5 years (range 4 to 17 years).
Mean BMI was 20.6 kg/m 2 . Glycemic control (see Table 9) was comparable for the two
treatment regimens.
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