Recombinant 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, HbA1c, diet, home blood glucose monitoring and frequency of hypoglycaemia were almost identical in the two treatment periods.(ABSTRACT TRUNCATED AT 250 WORDS)

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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-

The rapid development of new analgetic drugs calls for appropriate methods of evaluating their potency in animal experiments. Numerous methods have been devised, which can be classified into two categories according to the types of response metameter; 1. The graded response, where the response of each individual is given a definite value, and 2. the quanta1 all-or-noneresponse where the percentage of the group showing a reaction above a certain level is recorded.The general procedure is to compare the activity of all compounds to that of morphine. The assumption, underlying this Comparison, is that the reaction curves of all drugs are parallel, so that the same relative potency is found, at any level of response. This important factor has not always been sufficiently evaluated in the literature and much controversy as to relative potency may be explained, if the parallelism is not valid in all Another point of uncertainty is derived from the fact that some workers relate absolute response of the animals to the dose employed, while others use the increment in response, over the response of the same animal before treatment. The compatibility of these two ways of presenting the data needs clarification.The fundamental reaction curve to show the pharmacodynamic action, is that of the graded response, because its form is cases.

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