NovoLog (Page 5 of 8)
14.2 Continuous Subcutaneous Insulin Infusion (CSII) by External Pump
Two open-label, parallel design studies (6 weeks [n=29] and 16 weeks [n=118]) compared NovoLog to buffered regular human insulin (Velosulin) in adults with type 1 diabetes receiving a subcutaneous infusion with an external insulin pump. The two treatment regimens had comparable changes in HbA and rates of severe hypoglycemia. 1c
NovoLog | Buffered human insulin | |
N | 59 | 59 |
Baseline HbA (%) 1c * | 7.3 ± 0.7 | 7.5 ± 0.8 |
Change from Baseline HbA (%) 1c | 0.0 ± 0.5 | 0.2 ± 0.6 |
Treatment Difference in HbA Mean (95% confidence interval) 1c, | 0.3 (-0.1, 0.4) | |
Baseline insulin dose (IU/kg/24 hours) * | 0.7 ± 0.8 | 0.6 ± 0.2 |
End-of-Study insulin dose (IU/kg/24 hours) * | 0.7 ± 0.7 | 0.6 ± 0.2 |
Patients with severe hypoglycemia (n, %) † | 1 (2%) | 2 (3%) |
Baseline body weight (kg) * Weight Change from baseline (kg) * | 77.4 ± 16.1 0.1 ± 3.5 | 74.8 ± 13.8 -0.0 ± 1.7 |
A randomized, 16-week, open-label, parallel design study of children and adolescents with type 1 diabetes (n=298) aged 4-18 years compared two subcutaneous infusion regimens administered via an external insulin pump: NovoLog (n=198) or insulin lispro (n=100). These two treatments resulted in comparable changes from baseline in HbA and comparable rates of hypoglycemia after 16 weeks of treatment (see ). 1c Table 7
NovoLog | Lispro | |
N | 198 | 100 |
Baseline HbA (%) 1c * | 8.0 ± 0.9 | 8.2 ± 0.8 |
Change from Baseline HbA (%) 1c | -0.1 ± 0.8 | -0.1 ± 0.7 |
Treatment Difference in HbA Mean (95% confidence interval) 1c, | -0.1 (-0.3, 0.1) | |
Baseline insulin dose (IU/kg/24 hours) * | 0.9 ± 0.3 | 0.9 ± 0.3 |
End-of-Study insulin dose (IU/kg/24 hours) * | 0.9 ± 0.2 | 0.9 ± 0.2 |
Patients with severe hypoglycemia (n, %) † | 19 (10%) | 8 (8%) |
Diabetic ketoacidosis (n, %) | 1 (0.5%) | 0 (0) |
Baseline body weight (kg) * Weight Change from baseline (kg) * | 54.1 ± 19.7 1.8 ± 2.1 | 55.5 ± 19.0 1.6 ± 2.1 |
An open-label, 16-week parallel design trial compared pre-prandial NovoLog injection in conjunction with NPH injections to NovoLog administered by continuous subcutaneous infusion in 127 adults with type 2 diabetes. The two treatment groups had similar reductions in HbA and rates of severe hypoglycemia ( ) [ ]. 1c Table 8see , , and Indications and Usage (1)Dosage and Administration (2)Warnings and Precautions (5)How Supplied/Storage and Handling (16.2)
| ||
NovoLog pump | NovoLog + NPH | |
N | 66 | 61 |
Baseline HbA (%) 1c * | 8.2 ± 1.4 | 8.0 ± 1.1 |
Change from Baseline HbA (%) 1c | -0.6 ± 1.1 | -0.5 ± 0.9 |
Treatment Difference in HbA Mean (95% confidence interval) 1c, | 0.1 (0.4, 0.3) | |
Baseline insulin dose (IU/kg/24 hours) * | 0.7 ± 0.3 | 0.8 ± 0.5 |
End-of-Study insulin dose (IU/kg/24 hours) * | 0.9 ± 0.4 | 0.9 ± 0.5 |
Baseline body weight (kg) * Weight Change from baseline (kg) * | 96.4 ± 17.0 1.7 ± 3.7 | 96.9 ± 17.9 0.7 ± 4.1 |
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