NOVOMEDLINK™

This page contains information about Novo Nordisk products.

PPG and FPG improvements with NovoLog® Mix 70/30

NovoLog® Mix 70/30 provides better post prandial glucose (PPG) control versus human premix 70/301

Reduction in PPG (type 1 and type 2 diabetes)1

Reductions in PPG

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 insulin, 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; human premix 70/30, n=151.1

The IMPROVE™ study: along with A1C reductions, PPG and fasting plasma glucose (FPG) improvements were observed when converting to NovoLog® Mix 70/30 from human premix 70/302

  • PPG levels after breakfast were reduced by 99 mg/dL
  • FPG levels were reduced by 63 mg/dL

Results from patients who completed the IMPROVE™ study who were previously treated with human premix ± OAD therapy and had A1C values available at baseline and final visit. The IMPROVE™ study is a multinational, open-label, nonrandomized, 26-week, observational study evaluating the safety and efficacy of NovoLog® Mix 70/30 in patients with type 2 diabetes.2

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

References:

  1. Boehm BO, Home PD, Behrend C, Kamp NM, Lindholm A. Premixed insulin aspart 30 vs. premixed human insulin 70/30 twice daily; a randomized trial in type 1 and type 2 diabetic patients. Diabet Med. 2002;19(5):393-399.
  2. Shah S, Benroubi M, Borzi V, et al; IMPROVE Study Group Expert Panel. Safety and effectiveness of biphasic insulin aspart 30⁄70 (NovoMix 30) when switching from human premix insulin in patients with type 2 diabetes: subgroup analysis from the 6-month IMPROVE observational study. Int J Clin Pract. 2009;63(4):574-582.
  3. Valensi P, Benroubi M, Borzi V, et al, on behalf of IMPROVE™ Study Group Expert Panel. The IMPROVE™ study—a multinational, observational study in type 2 diabetes: baseline characteristics from eight national cohorts. Int J Clin Pract. 2008;62(11):1809-1819.
  4. Gumprecht J, Benroubi M, Borzi V, et al, on behalf of the IMPROVE™ Study Group Expert Panel. Intensification to biphasic insulin aspart 30/70 (BIAsp 30, NovoMix® 30) can improve glycaemic control in patients treated with basal insulins: a subgroup analysis of the IMPROVE™ observational study. Int J Clin Pract 2009;63(6):966-972.
  5. 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.