Apidra (insulin glulisine) - Sanofi Canada

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PHARMACEUTICAL INFORMATION Drug Substance PART II: SCIENTIFIC INFORMATION Proper name: insulin glulisine (rDNA origin) Chemical name: 3 B -lysine-29 B -glutamic acid-human insulin Molecular formula: C258H384N64O78S6 Molecular mass: 5823 Structural formula: CLINICAL TRIALS The safety and efficacy of APIDRA (insulin glulisine) was studied in adult patients with Type 1 and Type 2 diabetes (n = 2408) and in children and adolescent patients (4 to 17 years) with type 1 diabetes (n=572). The primary efficacy parameter was glycemic control, as measured by glycated hemoglobin (A1c). Type 1 Diabetes: A 26-week, randomized, open-label, active-control study (n = 672) was conducted in patients with Type 1 diabetes to assess the safety and efficacy of APIDRA compared to insulin lispro when administered subcutaneously within 15 minutes before a meal. Insulin glargine (LANTUS ® ) was administered once daily in the evening as the basal insulin in both groups. Before start of the study there was a 4-week run-in period combining insulin lispro and insulin Page 28 of 61
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. Page 29 of 61
Page 1 and 2: PRODUCT MONOGRAPH APIDRA ® insulin
Page 3 and 4: PRODUCT MONOGRAPH APIDRA ® insulin
Page 5 and 6: PHARMACOLOGY). APIDRA given by subc
Page 7 and 8: Hyperglycemia: The use of too low i
Page 9 and 10: and reduced insulin metabolism, sim
Page 11 and 12: Occupational Hazards The patient’
Page 13 and 14: Table 2 - Number (percentage) of pe
Page 15 and 16: Table 4 - Common (≥1%) Adverse Dr
Page 17 and 18: Table 5- Established or Potential D
Page 19 and 20: APIDRA should be administered by su
Page 21 and 22: ACTION AND CLINICAL PHARMACOLOGY Ph
Page 23 and 24: Table 7. Pharmacokinetic and Pharma
Page 25 and 26: gender did not show differences in
Page 27: Opened APIDRA SoloSTAR should not b
Page 31 and 32: treatment regimens. No differences
Page 33 and 34: TOXICOLOGY Single and Repeated Dose
Page 35 and 36: Table 14: Reproductive & Developmen
Page 37 and 38: Table 15: Reproductive & Developmen
Page 39 and 40: PART III: CONSUMER INFORMATION APID
Page 41 and 42: INTERACTIONS WITH THIS MEDICATION O
Page 43 and 44: 12. Make sure the tip of the needle
Page 45 and 46: Hyperglycemia Hyperglycemia (too mu
Page 47 and 48: MORE INFORMATION Your physician, ph
Page 49 and 50: APIDRA should be given within 15 mi
Page 51 and 52: Do not take a double dose to make u
Page 53 and 54: history of diabetes, or in patients
Page 55 and 56: MORE INFORMATION Your physician, ph
Page 57 and 58: efore or within 20 minutes after st
Page 59 and 60: Preparing the Dose 1. To avoid medi
Page 61: • redness, itching, swelling, or

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