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

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 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

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 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)

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

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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