A clinical transfer trial was conducted to ascertain whether semisynthetic human NPH insulin has a full 24-hour duration of therapeutic effect comparable to that of NPH insulin from animal sources. Diabetic patients requiring insulin and stabilized on a once-a-day (QD) regimen of animal NPH insulin were enrolled and entered a two-week run-in period during which the constancy of their insulin requirements and the stability of their glycemic control were assessed. At the end of run-in phase, baseline measurements were made of fasting blood glucose (FBG), hemoglobin A1C, C-peptide, and insulin antibodies. Patients then were transferred to a QD regimen of semisynthetic human NPH insulin (NOvolin(®) N) in the same dose as the animal insulin. Glycemic control was reassessed after 1, 4, and 8 weeks of therapy, and a global assessment of overall glycemic control was made at the conclusion of the study. Efficacy variables were analyzed for 39 patients. Most had non-insulin-dependent diabetes mellitus (NIDDM) and most were transferred from mixed beef/pork insulin. Six (15%) patients required significant adjustments in insulin dose or regimen; the remaining 85% completed the eight weeks of treatment with minimal changes in insulin dose. Mean values for FBG and hemoglobin A1C did not change significantly between baseline and the end of the study. The only statistically significant change was an increase in mean body weight (P ≤ 0.01). Results of the investigators' global assessments showed that 74% of the patients had unchanged or improved control of glycemia after transferring to semisynthetic human NPH insulin. The average frequency of hypoglycemic events was not significant changed. Nine patients reported adverse experiences during the study. Eight of these were unrelated to the insulin, and one complex of symptoms (diaphoresis, dizziness, and nausea) was of uncertain relationship. The latter patient and a patient with an unrelated complaint withdrew from the study. Conclusions from this study can be drawn for patients with NIDDM who were transferred from beef/pork insulin. The results show that the human semisynthetic NPH insulin used in this study has a 24-hour duration of therapeutic effect equivalent to that of beef/pork NPH insulin and that a transfer to such insulin at the same daily dose and regimen can be accomplished without loss of glycemic control.
|Original language||English (US)|
|Number of pages||9|
|State||Published - May 24 1989|
ASJC Scopus subject areas
- Pharmacology (medical)