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Low rate of major hypoglycemia with NovoLog® Mix 70/301

In a second year Boehm study, no major hypoglycemic episodes were seen in patients taking NovoLog® Mix 70/30 compared with human premix 70/301

Major hypoglycemic events1

Low rate of major hypoglycemic events

Incidence of major hypoglycemic episodes based on results from 21-month follow-up to initial 12-week study.

Multicenter, randomized, open-label, parallel-group, 12-week trial in 294 patients with type 1 or type 2 diabetes taking twice-daily NovoLog® Mix 70/30 or Novolin® 70/30 (70% NPH human insulin isophane suspension and 30% regular, human insulin Injection [recombinant DNA origin]). The mean daily PPG excursion for patients taking NovoLog® Mix 70/30 was 30 mg/dL versus 42 mg/dL for patients taking human premix 70/30. Intent-to-treat population: NovoLog® Mix 70/30, n=140; Novolin® 70/30, n=151.

First- and second-year data were derived from a 21-month follow-up to the initial 12-week study (see study description above). Patients in the study with type 2 diabetes—first year: NovoLog® Mix 70/30, n=56, 3 events reported; human premix 70/30, n=65, 11 events reported. In the NovoLog® Mix 70/30 group, second year: NovoLog® Mix 70/30, n=46, 0 events reported; human premix 70/30, n=60, 8 events reported.1

  • Episodes of minor hypoglycemia were comparable with human premix 70/301

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References:

  1. Boehm BO, Vaz JA, Brøndsted L, Home PD. Long-term efficacy and safety of biphasic insulin aspart in patients with type 2 diabetes. Eur J Intern Med. 2004;15(8):496-502.

  1. NovoLog® Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin]) Indications and Usage

    NovoLog® Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin]) is an insulin analog indicated to improve glycemic control in patients with diabetes mellitus.

    Important Limitations of Use:
    In premix insulins, such as NovoLog® Mix 70/30, the proportions of rapid acting and long acting insulins are fixed and do not allow for basal versus prandial dose adjustments.

    NovoLog® Mix 70/30 Important Safety Information

    NovoLog® Mix 70/30 is contraindicated during episodes of hypoglycemia and in patients hypersensitive to NovoLog® Mix 70/30 or one of its excipients.

    NovoLog® Mix 70/30 has a faster onset of action than human insulin premix 70/30 and should be dosed within 15 minutes before meal initiation for patients with type 1 diabetes. For patients with type 2 diabetes, dosing should occur within 15 minutes before or after meal initiation.

    NovoLog® Mix 70/30 should not be administered intravenously or used in insulin infusion pumps. NovoLog® Mix 70/30 should not be mixed with any other insulin product.

    Hypoglycemia is the most common adverse effect of insulin therapy, including NovoLog® Mix 70/30. The timing of hypoglycemia may reflect the time-action profile of the insulin formulation. Glucose monitoring is recommended for all patients with diabetes. Any change of insulin should be made cautiously and only under medical supervision.

    Needles and NovoLog® Mix 70/30 FlexPen® must not be shared.

    Severe, life-threatening generalized allergy, including anaphylaxis, may occur with insulin products, including NovoLog® Mix 70/30. Adverse reactions observed with NovoLog® Mix 70/30 include hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash, and pruritus. Insulin, particularly when given in settings of poor glycemic control, may cause hypokalemia. Like all insulins, NovoLog® Mix 70/30 requirements may be reduced in patients with renal impairment or hepatic impairment.

    The safety and effectiveness of NovoLog® Mix 70/30 has not been established in pediatric patients. Clinical studies of NovoLog® Mix 70/30 did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients.

    The significance, with respect to the long-term clinical sequelae of diabetes, of the differences in postprandial hyperglycemia between treatment groups has not been established.

    Please click hereclick here for Prescribing Information.

FlexPen®, Novolin®, and NovoLog® are registered trademarks of Novo Nordisk A/S. NovoMedLink™ is a trademark of Novo Nordisk A/S.