A 6-month randomized, crossover, open-label, active-controlled study was conducted in insulin-treated patients with type 2 diabetes (n=722) to assess the safety and efficacy of HUMALOG for 3 months followed by Humulin R for 3 months or the reverse sequence. HUMALOG was administered by subcutaneous injection immediately before meals and Humulin R was administered 30 to 45 minutes before meals. Humulin® N [NPH human insulin (rDNA origin) isophane suspension] or Humulin U was administered once or twice daily as the basal insulin. All patients participated in a 2- to 4-week run-in period with Humulin R and Humulin N or Humulin U. Most of the patients were Caucasian (88%), and the numbers of men and women in each group were approximately equal. The mean age was 58.6 years (range 23.8 to 85 years). The average body mass index (BMI) was 28.2 kg/m2. During the study, the majority of patients used Humulin N (84%) compared with Humulin U (16%) as their basal insulin. The reductions from baseline in HbA1c and the incidence of severe hypoglycemia (as determined by the number of events that were not self-treated) were similar between the two treatments from the combined groups (see Table 5).
a Values are Mean ± SD
b Severe hypoglycemia refers to hypoglycemia for which patients were not able to self-treat.
|HbA1c (%)a||8.9 ± 1.7||8.2 ± 1.3||8.2 ± 1.4|
|Change from baseline HbA1c (%)a||—||-0.7 ± 1.4||-0.7 ± 1.3|
|Short-acting insulin dose (units/kg/day)a||0.3 ±0.2||0.3 ± 0.2||0.3 ±0.2|
|Change from baseline short-acting insulin dose (units/kg/day)a||—||0.0 ± 0.1||0.0 ± 0.1|
|Body weight (kg)a||80 ± 15||81 ± 15||81 ±15|
|Weight change from baseline||—||0.8 ± 2.7||0.9 ± 2.6|
|Patients with severe hypoglycemia (n, %)b||—||15 (2%)||16 (2%)|
An 8-month, crossover study of adolescents with type 1 diabetes (n=463), aged 9 to 19 years, compared two subcutaneous multiple-dose treatment regimens: HUMALOG or Humulin R, both administered with Humulin N (NPH human insulin) as the basal insulin. HUMALOG achieved glycemic control comparable to Humulin R, as measured by HbA1c (see Table 6), and both treatment groups had a comparable incidence of hypoglycemia. In a 9-month, crossover study of prepubescent children (n=60) with type 1 diabetes, aged 3 to 11 years, HUMALOG administered immediately before meals, HUMALOG administered immediately after meals and Humulin R administered 30 minutes before meals resulted in similar glycemic control, as measured by HbA1c , and incidence of hypoglycemia, regardless of treatment group.
a Values are Mean ± SD
b Severe hypoglycemia refers to hypoglycemia that required glucagon or glucose injection or resulted in coma.
|HbA1c (%)a||8.6 ± 1.5||8.7 ± 1.5||8.7 ± 1.6|
|Change from baseline HbA1c (%)a||—||0.1 ± 1.1||0.1 ± 1.3|
|Short-acting insulin dose (units/kg/day)a||0.5 ± 0.2||0.5 ± 0.2||0.5 ± 0.2|
|Change from baseline short-acting insulin dose (units/kg/day)a||—||0.01 ± 0.1||-0.01 ± 0.1|
|Body weight (kg)a||59.1 ± 13.1||61.1 ± 12.7||61.4 ± 12.9|
|Weight change from baseline (kg)a||—||2.0 ± 3.1||2.3 ± 3.0|
|Patients with severe hypoglycemia (n, %)b||—||5 (1.1%)||5 (1.1%)|
|Diabetic ketoacidosis (n, %)||—||11 (2.4%)||9 (1.9%)|
To evaluate the administration of HUMALOG via external insulin pumps, two open-label, crossover design studies were performed in patients with type 1 diabetes. One study involved 39 patients, ages 19 to 58 years, treated for 24 weeks with HUMALOG or regular human insulin. After 12 weeks of treatment, the mean HbA1c values decreased from 7.8% to 7.2% in the HUMALOG-treated patients and from 7.8% to 7.5% in the regular human insulin-treated patients. Another study involved 60 patients (mean age 39, range 15 to 58 years) treated for 24 weeks with either HUMALOG or buffered regular human insulin. After 12 weeks of treatment, the mean HbA1c values decreased from 7.7% to 7.4% in the HUMALOG-treated patients and remained unchanged from 7.7% in the buffered regular human insulin-treated patients. Rates of hypoglycemia were comparable between treatment groups in both studies.
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