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Efficacy and Safety

Apidra® Results in Clinical Studies

Learn how Apidra demonstrated A1C reduction and BG control in adults with type 2 diabetes mellitus in an OPAL (Orals Plus Apidra and Lantus® (insulin glargine injection) 100 Units/mL study, Apidra vs. RHI Study in Type 2 diabetes patients, and what results a PHILOTHEOU study showed in patients 4-17 years of age with type 1 diabetes mellitus.

A1C Reduction and Blood Glucose Control — OPAL STUDY

Efficacy: Apidra Basal-Plus 1 regimen helped patients reach A1C goal1

  • The adjusted mean baseline to endpoint changes in A1C were comparable between the breakfast (-0.31%) and main mealtime (-0.36%) glulisine injection groups
  • Treatment equivalence of both breakfast and main meal Apidra regimens was demonstrated (n=162 and n=152, respectively)
  • Adding 1 dose of Apidra a day to Lantus (insulin glargine injection) and OADs resulted in significant A1C reductions from baseline to endpoint: breakfast group, from 7.35% to 7.03%; main meal group, from 7.29% to 6.94%1

Improvements in BG control were significant in both breakfast and main meal groups1

Improved 8-pt BG profiles for breakfast (n=162) and main meal (n=152) groupsa

 
  • Significant PPG reductions from baseline to endpoint were recorded as follows: breakfast group, from 172.6 mg/dL to 137.3 mg/dL; main meal group, from 187.9 mg/dL to 153.1 mg/dL (P<0.0001 for both groups)1
  • In the breakfast arm, improved BG levels also extended to the pre-lunch period1

Efficacy: Apidra Basal-Plus 1 regimen helped patients reach A1C goal1

  • The adjusted mean baseline to endpoint changes in A1C were comparable between the breakfast (-0.31%) and main mealtime (-0.36%) glulisine injection groups
  • Treatment equivalence of both breakfast and main meal Apidra regimens was demonstrated (n=162 and n=152, respectively)
  • Adding 1 dose of Apidra a day to Lantus (insulin glargine injection) and OADs resulted in significant A1C reductions from baseline to endpoint: breakfast group, from 7.35% to 7.03%; main meal group, from 7.29% to 6.94%1
 
  • In a subgroup of patients with baseline A1C >7%, Apidra Basal-Plus 1 at the main meal helped more than 50% of patients achieve A1C ≤7%1

Safety Results

 

a Severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia during which the person required the assistance of another person which was associated with blood glucose level below 36 mg/dL (2.0 mmol/l) and/or an administration of oral carbohydrate, intravenous glucose or glucagons.2

b P=NS.

c Evaluated for safety.

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24-week, multicenter, parallel, open-label, 1:1 randomized study comparing the efficacy of Apidra administered at breakfast or the main meal in 316 patients ≥18 years with type 2 diabetes who were previously uncontrolled on Lantus (insulin glargine injection) and OADs and whose A1C was >6.5% and <9%. At the end of the screening phase, 316 patients with FBG ≤120mg/dL were randomized and administered 1 injection of Apidra at either breakfast (n=162) or main mealtime (n=154). The dosage was individually titrated at the investigator’s discretion to the target goals of 2h PPG ≤135 mg/dL and FBG ≤100 mg/dL in the absence of hypoglycemia.

T1DM PHILOTHEOU Study for Young Patients

Efficacy: Greater A1C Goal Achievement

In T1DM: Significantly more young patients (ages 4-17) achieved A1C goal vs. lispro‡ 2,3

  • Primary endpoint: baseline to endpoint mean A1C changes were similar between groups (Apidra 0.1%; lispro 0.2%)2

e For all age groups together, the percentage of subjects achieving the ADA-recommended A1C target (7.5%-8.5% for children less than 6 years old, <8% for children 6-12 years old, and <7.5% for children/adolescents over 12 years of age).4

ADA target has changed for toddlers and preschoolers (0-6) to A1C <7.5%.4

‡ For the purpose of this trial, references to lispro refer to Humalog® (insulin lispro).

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Philotheou study: A 26-week, open-label, active-control, noninferiority study to compare the efficacy and safety of Apidra (n=277) with lispro (n=295) added to Lantus or NPH in a basal-bolus regimen. Subjects with T1DM (ages 4-17) were randomized to receive Apidra or lispro 0-15 minutes premeal. Primary endpoint was mean change in A1C from baseline to endpoint.1,2

Safety Results

T1DM, type 1 diabetes mellitus

A1C Reduction in Type 2 Diabetes

   

a Last available measure after start of treatment.

n=876 (Apidra: n=435; RHI: n=441)

A1C was significantly reduced with Apidra in patients with type 2 diabetes5,2

  • All efficacy variables were determined using the intent-to-treat population5
  • Statistically significant reductions from baseline observed with glulisine (-0.46%) versus RHI (-0.30%) from 12 weeks onwards (P<0.05)5
  • The clinical relevance of the difference in A1C reductions between RHI and Apidra is unknown

Safety Results

   

b Severe symptomatic hypoglycemia was defined as symptomatic hypoglycemia requiring assistance from another person and confirmed by BG <36 mg/dL or associated with prompt recovery following oral carbohydrate, intravenous glucose, or glucagon administration. All severe hypoglycemia episodes are considered as serious adverse events.5

c P=NS.

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A 26-week, randomized, open-label, active-control, study compared Apidra with RHI given premeal in 876 type 2 diabetes patients, 30 to 80 years old, with BMI <45 kg/m2 and A1C >7.5%. Both groups were given intermediate-acting basal insulin twice daily; mean baseline A1C of 7.6%. Subjects continued the same dose of prestudy OAD regimen unless hypoglycemia necessitated changes. The treatment consisted of 2 injections of Apidra or 2 injections of RHI in addition to 2 injections of NPH. More than 2 injections of RHI or Apidra were permitted as per investigators’ judgment. Apidra or RHI was individually dosed as appropriate, prior to at least 2 meals a day (breakfast and dinner). Endpoint was last available measurement after start of treatment.5

   

NOS=not otherwise specified.

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