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 HbA1c and rates of severe hypoglycemia.

Table 6. Adult Insulin Pump Study in Type 1 Diabetes (16 weeks; n=118)
*
Values are Mean ± SD
Severe hypoglycemia refers to hypoglycemia associated with central nervous system symptoms and requiring the intervention of another person or hospitalization.

NovoLog

Buffered human insulin

N

59

59

Baseline HbA1c (%)*

7.3 ± 0.7

7.5 ± 0.8

Change from Baseline HbA1c (%)

0.0 ± 0.5

0.2 ± 0.6

Treatment Difference in HbA1c, Mean (95% confidence interval)

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 HbA1c and comparable rates of hypoglycemia after 16 weeks of treatment (see Table 7).

Table 7. Pediatric Insulin Pump Study in Type 1 Diabetes (16 weeks; n=298)
*
Values are Mean ± SD
Severe hypoglycemia refers to hypoglycemia associated with central nervous system symptoms and requiring the intervention of another person or hospitalization.

NovoLog

Lispro

N

198

100

Baseline HbA1c (%)*

8.0 ± 0.9

8.2 ± 0.8

Change from Baseline HbA1c (%)

-0.1 ± 0.8

-0.1 ± 0.7

Treatment Difference in HbA1c, Mean (95% confidence interval)

-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 HbA1c and rates of severe hypoglycemia (Table 8) [see Indications and Usage (1), Dosage and Administration (2), Warnings and Precautions (5) and How Supplied/Storage and Handling (16.2)].

Table 8. Pump Therapy in Type 2 Diabetes (16 weeks; n=127)
*
Values are Mean ± SD

NovoLog pump

NovoLog + NPH

N

66

61

Baseline HbA1c (%)*

8.2 ± 1.4

8.0 ± 1.1

Change from Baseline HbA1c (%)

-0.6 ± 1.1

-0.5 ± 0.9

Treatment Difference in HbA1c, Mean (95% confidence interval)

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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