Long-term comparison of human insulin analogue B10Asp and soluble human insulin in IDDM patients on a basal/bolus insulin regimen

Abstract

SummaryRecombinant DNA technology allows the production of insulin analogues with faster absorption rates from subcutaneous tissue as compared to soluble human insulin. The human insulin analogue B10Asp (mono/dimeric) is absorbed twice as fast as soluble human insulin (hexameric). A double blind, randomised crossover study with a 1-month run-in period and two 2-month treatment periods was performed in 21 male insulin-dependent diabetic (IDDM) patients aged 18-40 years in order to compare the metabolic control obtained with equimolar doses of the analogue B10Asp vs soluble human insulin (Actrapid) given as mealtime insulin and intermediate acting isophane insulin (Protaphane) at bedtime. At the end of each 2-month study period, the patients were admitted to the metabolic ward. We found significantly higher plasma insulin/analogue leVels after breakfast, lunch and dinner with B10Asp as compared to Actrapid (p < 0.05). The plasma insulin/analogue levels were significantly lower before lunch and dinner with B10Asp as compared to Actrapid (p < 0.05). Also, the plasma insulin/analogue level tended to be lower at bedtime when comparing B10Asp to Actrapid. The 24-h blood glucose profiles showed identical fasting blood glucose, significantly lower blood glucose after breakfast with the analogue (p < 0.05), no differences in blood glucose after lunch and dinner but a significantly higher blood glucose at midnight using the analogue (p < 0.05). The overall 24-h mean blood glucose concentrations, the daily insulin dose, HbAlc, diet, home blood glucose monitoring and frequency of hypoglycaemia were almost identical in the two treatment periods. In conclusion, the overall glycaemic control remained unchanged and quite good when Actrapid was exchanged dose for dose with the insulin analogue B10Asp in IDDM patients treated with a basal bolus regime. [Diabetologia (1995) 38: 592-598] Key words IDDM, insulin analogues, metabolic control.Several randomised studies dealing with small numbers of insulin-dependent diabetic (IDDM) patients have unanimously suggested that the initiation and progression of the early stages of diabetic retinopathy and nephropathy can be delayed or even prevented by strict metabolic control [1][2][3][4][5][6][7][8][9][10]. The DCCT trial has confirmed and extended these studies by demon-

Systematic Review and Meta-analysis of Short-Acting Insulin Analogues in Patients With Diabetes Mellitus

“…11,12 Despite this theoretical superiority of SAI analogues over regular insulin, it is unclear whether the efficacy of SAI analogues in the treatment of diabetic patients is better than with human regular insulin. 13,14 Treatment with the 2 SAI analogues available on the market is currently promoted with purported advantages with respect to metabolic control, reduced incidence of hypoglycemic episodes, and improved quality of life for patients with diabetes mellitus. We performed a systematic review and meta-analysis according to the QUOROM statement 15 of randomized controlled trials with the aim of providing information on glucose control, hypoglycemia, quality of life, and diabetes-specific complications of SAI analogues compared with regular insulin.…”

Evaluation of the Carcinogenic Potential of Insulin Glargine (LANTUS) in Rats and Mice

“…For example, previous studies have shown that the insulin analog [B10-Asp]-insulin caused mammary tumors in rats (Jorgensen, Dideriksen, and Drejer 1992). [B10-Asp]-insulin has, however, only been tested for 2 months in patients with type 1 diabetes, but has never been used for long-term treatment (Nielsen et al 1995). One possible explanation for the carcinogenic activity of [B10-Asp]-insulin is that it is characterized by an increased level of binding to the insulin-like growth factor-1 (IGF-1) receptor as demonstrated by in vitro binding studies.…”

Optimal Provision of Daytime NPH Insulin in Patients Using the Insulin Analog Lispro

“…However, the present study has also clearly demonstrated that an appropriate dose of NPH can be chosen to prevent the preprandial deterioration of glucose levels noted with the lispro regimen (21)(22)(23)(24). We chose a dose based on the 30% reduction in lispro dose at both the current (lunch) and the next (dinner) meal, thus keeping the total insulin dose equivalent for experimental purposes and resulting in an approximate 50:50 mixture of lispro:NPH at lunchtime.…”