
Profile
Contact Information
Contact: Novo Nordisk
General Information
Novolog Mix is a mixture of insulin aspart protamine, an intermediate-acting human insulin analog, and insulin aspart, a rapid-acting human insulin analog.
Novolog Mix is specifically indicated to improve glycemic control in adult patients with diabetes mellitus.
Novolog Mix is supplied as a subcutaneous injection. Inject Novolog Mix 70/30 subcutaneously in the abdominal region, buttocks, thigh, or upper arm Administer the dose within 15 minutes before meal initiation. For patients with type 2 diabetes, the dose may also be given after meal initiation. Rotate injection sites within the same region from one injection to the next to reduce risk of lipodystrophy and localized cutaneous amyloidosis.
Novolog Mix 70/30 is typically dosed twice-daily (with each dose intended to cover 2 meals or a meal and a snack). Individualize dosage based on metabolic needs, blood glucose monitoring results, glycemic control goal . Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness. Dosage adjustment may be needed when switching from another insulin to Novolog Mix 70/30.
Mechanism of Action
NovoLog Mix 70/30 regulates glucose metabolism. Insulins, including Novolog Mix, bind to insulin receptors on muscle and fat cells. They lower blood glucose by facilitating the cellular uptake of glucose, while simultaneously inhibiting the output of glucose from the liver.
Side Effects
Adverse events associated with the use of human insulin therapy include (but are not limited to) the following:
- Injection site reaction
- Lipodystrophy
- Pruritus
- Rash
- Hypoglycemia
Clinical Trial Results
In a three-month, open-label trial, patients with type 1 (n=104) or type 2 (n=187) diabetes were treated twice daily (before breakfast and before supper) with Novolog Mix 70/30 or Novolin 70/30. Patients had received insulin for at least 24 months before the study. Oral hypoglycemic agents were not allowed within 1 month prior to the study or during the study. The small changes in HbA1c were comparable across the treatment groups.
Approval Date: 2001-11-01
Company Name: Novo Nordisk