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Humalog in Combination with Sulfonylurea Agents-- In a two-month study in patients with fasting hyperglycemia despite maximal dosing with sulfonylureas (SU), patients were randomized to one of three treatment regimens; Humulin NPH at bedtime plus SU, Humalog three times a day before meals plus SU, or Humalog three times a day before meals and Humulin NPH at bedtime. The combination of Humalog and SU resulted in an improvement in HbA1c accompanied by a weight gain (see Table 2). Table 2 Results of a Two-Month Study in Which Humalog Was Added to Sulfonylurea Therapy in Patients Not Adequately Controlled on Sulfonylurea Alone. Humulin N h. s.+ SU Humalog a. c. + SU Humalog a. c. + Humulin N h. s. Randomized (n) 135 139 149 HbA1c (%) at baseline 9.9 10.0 10.0 HbA1c (%) at 2-months 8.7 8.4 8.5 HbA1c (%) change from baseline -1.2 -1.6 -1.4 Weight gain at 2-months (kg) 0.6 1.2 1.5 Hypoglycemia* (events/ mo) 0.11 0.03 0.09 Number of injections 1 3 4 Total insulin dose (U/ kg) at 2-months 0.23 0.33 0.52 a. c.-three times a day before meals, h. s.-at bedtime, SU-oral sulfonylurea agent * blood glucose 36mg/ dL or needing assistance from third party Text Continues Below
Special Populations-- Age and Gender-- Information on the effect of age and gender on the pharmacokinetics of Humalog is unavailable. However, in large clinical trials, subgroup analysis based on age and gender did not indicate any difference in postprandial glucose parameters between Humalog and human regular insulin. Smoking-- The effect of smoking on the pharmacokinetics and glucodynamics of Humalog has not been studied. Pregnancy-- The effect of pregnancy on the pharmacokinetics and glucodynamics of Humalog has not been studied. Obesity-- The effect of obesity and/ or subcutaneous fat thickness on the pharmacokinetics and glucodynamics of Humalog has not been studied. In large clinical trials, which included patients with Body Mass Index up to and including 35 kg/ m 2 , no consistent differences were seen between Humalog and Humulin R with respect to postprandial glucose parameters. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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