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Effective A1C reductions with NovoLog® Mix 70/301-3

Overall A1C reductions from the IMPROVE™ study (global cohort)1

Reductions in mean A1C1

Reduction in mean A1C

Results from the IMPROVE™ observational study, a 26-week, open-label, nonrandomized, multicenter study conducted in 11 countries. IMPROVE™ assessed the safety and efficacy of NovoLog® Mix 70/30 in patients with type 2 diabetes (N=52,419).1

See specific efficacy and safety data:

Learn about A1C reductions in different patients with different needs

See how NovoLog® Mix 70/30 can result in significant A1C reductions, and a low rate of hypoglycemia, in patients converting from human premix insulin.2

Watch video

In 2 studies, dosing once or twice daily, NovoLog® Mix 70/30 helped the majority of patients reach A1C goal ≤7%5,6

Patients reaching A1C goal

A 48-week, open-label, observational study in 100 patients 18 years or older with type 2 diabetes for >12 months and A1C levels between 7.5% and 10%. Patients had been previously treated on a stable antidiabetic regimen for at least 3 months. NovoLog® Mix 70/30 was initiated once daily during phase 1 and titrated in phases to dosing schedules of twice daily (phase 2) and three times daily (phase 3) as needed to reach treatment goals. Results for patients treated three times daily are not presented in these data.5

A 28-week, randomized, multicenter, open-label, parallel-group, treat-to-target study that enrolled 233 insulin-naive patients with A1C >8% on 1000 mg/day metformin alone or in combination with other OADs. Metformin was titrated to 2550 mg/day over a 4-week optimization period before initiating insulin with 5-6 units of NovoLog® Mix 70/30 twice daily or 10-12 units of insulin glargine at bedtime, titrated to target blood glucose (80-110 mg/dL) by algorithm-directed titration. Two hundred and nine (209) patients completed the study.6

References:

  1. 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.
  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. 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.
  4. American Diabetes Association. Standards of Medical Care in Diabetes—2011. Diabetes Care. 2010;34(suppl 1):S11-S61.
  5. Garber AJ, Wahlen J, Wahl T, et al. Attainment of glycaemic goals in type 2 diabetes with once-, twice-, or thrice-daily dosing with biphasic insulin aspart 70/30 (the 1-2-3 study). Diabetes Obes Metab. 2006;8(1):58-66.
  6. Raskin P, Allen E, Hollander P, et al; for the INITIATE Study Group. Initiating insulin therapy in type 2 diabetes: a comparison of biphasic and basal insulin analogs. Diabetes Care. 2005;28(2):260-265.
  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.