Apidra (insulin glulisine) - Sanofi Canada

Table 9: Type 1 Diabetes Mellitus–Pediatric
Treatment duration 26 weeks
(mITT)
Treatment in combination with: NPH or LANTUS ® (insulin glargine)
APIDRA Insulin lispro
A1c (%)
Number of patients 271 291
Baseline mean 8.20 8.17
Endstudy mean 8.31 8.37
Adjusted mean change from baseline 0.10 0.16
APIDRA – Insulin lispro -0.06
95% CI for treatment difference
Basal insulin dose (U/day)
(-0.24; 0.12)
Baseline mean 27.20 26.55
Endstudy mean
Rapid-acting insulin dose (U/day)
28.44 28.86
Baseline mean 24.26 24.34
Endstudy mean 25.48 26.97
Percentage of patients with an average number of
rapid-acting insulin injections per day ≥ 3
Body Weight (kg)
77.0 80.3
Baseline mean 51.5 50.8
Endstudy mean 53.6 53.0
Mean weight change from baseline 2.2 2.2
Type 2 Diabetes:
A 26-week, randomized, open-label, active-control study (n = 876) was conducted in insulintreated
patients with Type 2 diabetes to assess the safety and efficacy of APIDRA given within
15 minutes before a meal compared to regular human insulin administered 30 to 45 minutes prior
to a meal. NPH human insulin was given twice a day as the basal insulin. All patients
participated in a 4-week run-in period combining regular human insulin and NPH human insulin.
The average body mass index (BMI) of patients was 34.55 kg/m 2 . At randomization, 58% of the
patients were on an oral antidiabetic agent and were instructed to continue use of their oral
antidiabetic agent at the same dose. The majority of patients (79%) mixed their short-acting
insulin with NPH human insulin immediately prior to injection. Changes from baseline to
endpoint in A1c were –0.46 in the insulin glulisine group and –0.30 in the regular insulin group.
The difference in adjusted means between the 2 treatments was –0.16 (95% C1 ranging from –
0.26 to –0.05) with respective p value of 0.0029. At end of treatment period, postprandial blood
glucose levels in the APIDRA group were lower than in the regular human insulin group. The
rates of hypoglycemia, requiring intervention from a third party, were comparable for the two
Page 30 of 61