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Novolin R

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Novolin R

Novolin R

CLINICAL PHARMACOLOGY

Mechanism of Action

The primary activity of Novolin R is the regulation of glucose metabolism. Insulins, including Novolin R, bind to insulin receptors on muscle and adipocytes and lower blood glucose by facilitating the cellular uptake of glucose and simultaneously inhibiting the output of glucose from the liver.

Pharmacodynamics

Novolin R is a short-acting insulin. When injected subcutaneously, the glucose-lowering effect of Novolin R begins approximately 30 minutes post-dose, is maximal between 1.5 and 3.5 hours post-dose and terminates approximately 8 hours post-dose. The onset of action of Novolin R, when administered intravenously, is more rapid in comparison to the subcutaneous administration. When injected subcutaneously, Novolin R has a slower onset of action and longer duration of action compared to the rapid-acting insulin analogs.

Pharmacokinetics

After single subcutaneous administration of 0.1 unit/kg of Novolin R to healthy subjects, peak insulin concentrations occurred between 1.5 to 2.5 hours post-dose. On average, insulin concentrations returned to baseline at around 5 hours post-dose.

The effects of sex, age, obesity, ethnic origin, renal and hepatic impairment, pregnancy, and smoking, on the pharmacodynamics and pharmacokinetics of Novolin R have not been studied.

Clinical Studies

Please see Section 12 CLINICAL PHARMACOLOGY for information on the pharmacokinetics and pharmacodynamics of Novolin R.

Type 1 diabetes mellitus (adults)

Two six-month, open-label, active-controlled studies were conducted to compare the safety and efficacy of Novolin R and insulin aspart in adults with type 1 diabetes. Insulin aspart was administered by subcutaneous injection immediately prior to meals and Novolin R was administered by subcutaneous injection 30 minutes before meals. Both treatment groups also received subcutaneous injections of NPH insulin in either single or divided daily doses. Because the two study designs and results were similar, data are shown for only one study (see Table 6)

Table 6: Subcutaneous Novolin R Administration in Type 1 Diabetes (24 weeks; N=882)

  Novolin R + NPH
N=286
Insulin aspart + NPH
N=596
Baseline HbAlc (%)* 8.0 ±1.2 7.9 ±1.1
Change from Baseline HbAlc (%)* 0.0 ± 0.8 -0.1 ±0.8
Treatment Difference in HbAlc, Mean (95% confidence interval) Novolin R - insulin aspart group 0.2 [0.1; 0.3]
Baseline, total insulin dose (units/kg/day)* 0.7 ± 0.2 0.7 ± 0.2
End-of-Study, total insulin dose (units/kg/day)* 0.7 ± 0.2 0.7 ± 0.2
Baseline body weight (kg)* Weight Change from baseline (kg)* 75.9 ±13.1 0.9 ± 2.9 75.3 ± 14.5 0.5 ± 3.3
*Values are Mean ± SD

Type 2 diabetes mellitus (adults)

A six-month, open-label, active-controlled study was conducted to compare the safety and efficacy of Novolin R and insulin aspart in adults with type 2 diabetes (Table 7). Insulin aspart was administered by subcutaneous injection immediately prior to meals and Novolin R was administered by subcutaneous injection 30 minutes before meals. Both treatment groups also received subcutaneous injections of NPH insulin in either single or divided daily doses.

Table 7: Subcutaneous Novolin R Administration in Type 2 Diabetes (24 weeks; N=182)

  Novolin R + NPH
N = 91
Insulin aspart + NPH
N = 91
Baseline HbAlc (%)* 7.8 ±1.1 8.1 ±1.2
Change from Baseline HbAlc (%)* -0.1 ±0.8 -0.3 ±1.0
Treatment Difference in HbAlc Mean (95% confidence interval)
Novolin R - insulin aspart group
0.1 [-0.1; 0.4]
Baseline, total insulin dose (units/kg/day)* 0.6 ± 0.3 0.6 ± 0.3
End-of-Study, total insulin dose (units/kg/day)* 0.7 ± 0.3 0.7 ± 0.3
Baseline body weight (kg)*
Weight Change from baseline (kg)*
85.8 ± 14.8
0.4 ±3.1
88.4 ±13.3
1.2 ±3.0
*Values are Mean ± SD

Type 1 diabetes mellitus (children and adolescents)

A six-month, open-label, active-controlled study was conducted to compare the safety and efficacy of Novolin R and insulin aspart in children and adolescents aged 6-18 years with type 1 diabetes (Table 8). Insulin aspart was administered by subcutaneous injection immediately prior to meals and Novolin R was administered by subcutaneous injection 30 minutes before meals. Both treatment groups also received subcutaneous injections of NPH insulin.

Table 8: Subcutaneous Novolin R Administration in Children and Adolescents with Type 1 Diabetes (24 weeks; N=283)

  Novolin R + NPH
N=96
Insulin aspart + NPH
N=187
Baseline HbAlc (%)* 8.3+1.3 8.3+1.2
Change from Baseline HbAlc (%)* 0.1 + 1.1 0.1+1.0
Treatment Difference in HbAlc; Mean (95% confidence interval) Novolin R - insulin aspart group # 0.2 [-0.1; 0.5]
Baseline, total insulin dose (units/kg/day)* 1.0 + 0.4 1.0 + 0.3
End-of-Study, total insulin dose (units/kg/day)* 1.2 + 0.4 1.2 + 0.4
Diabetic ketoacidosis n (%) 2 (2%) 10 (5%)
Baseline body weight (kg)*
Weight Change from baseline (kg)*
48.7+15.8
2.4 + 2.6
50.6+19.6
2.7 + 3.5
* Values are Mean ± SD
# The treatment difference and corresponding 95% confidence interval is based on the Analysis of Covariance Model

Novolin R and insulin aspart have also been compared in an open-label, randomized, crossover trial in 26 children with type 1 diabetes aged 2-6 years. Patients received each treatment for 12 weeks. Insulin aspart was administered by subcutaneous injection immediately prior to meals and Novolin R was administered by subcutaneous injection 30 minutes before meals. Both treatment groups also received subcutaneous injections of NPH insulin. In this study, the mean baseline HbAic was 7.8%. The estimated HbAic at end of treatment was 7.6% with Novolin R and 7.7% with insulin aspart.

Last reviewed on RxList: 4/5/2012
This monograph has been modified to include the generic and brand name in many instances.

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