Human Insulin: Clinical Pharmacological Studies in Normal Man

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Springer Science & Business Media, 31 мая 1986 г. - Всего страниц: 312
Since insulin became available for the treatment of diabetes in 1922 a number of major advances have been made, which include the modification of insulin to vary its timing of action, its purification, and latterly, the production of human insulin. Human insulin in quantities sufficiently large for therapy has been made available by two techniques developed in parallel during the late 1970s. These involve either (i) formulation in E. coli bacteria suitably encoded by DNA recombinant methods of the A- and B-chains of human insulin followed by a chain combination reaction ('biosynthetic' human insulin) or (ii) enzymatic conversion (transpeptidation) of porcine insulin brought to react with a threonine ester by porcine trypsin in a mixture of water and organic solvents, yielding human insulin ('semi-synthetic' human insulin). This book includes the first clinical-pharmacological studies of each of the highly purified 'semi-synthetic' human insulin preparations: Actrapid ® HM; Monotard® HM; Protaphane® HM; Actraphane® HM; and Ultratard® HM (Novo Industri A/S, Copenhagen). The preliminary studies established their safety and efficacy relative to their porcine and bovine counterparts emphasising the relevance of species and formulation on the pharmacokinetics and biological responses to insulin. Additional investigations with human insulin demonstrated the influence of insulin concentration, site of administration, the addition of aprotinin to insulin and the mixing of 'short-' and 'intermediate-acting' formulations on insulin 'bioavailability'. Examination of the 'within' and 'between' subject day-to-day variation in absorption and the effect of subcutaneous insulin also demonstrates the dominating influence of insulin responsiveness.
 

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Содержание

Introduction
1
112 The discovery of insulin
5
113 Summary
9
12 THE EVOLUTION OF INSULIN
10
122 Purity and immunogenicity of insulin
12
1222 Clinical implications of the quest for insulin purity
15
insulin species etc
18
123 Human insulin
19
42 INSULIN PREPARATIONS WITH PROLONGED EFFECT
134
421 Intermediateacting insulin preparations
135
4212 A study of human semisynthetic and biosynthetic and porcine NPH isophane insulins U40
151
U100 U40 porcine insulin U40
161
422 Longacting insulin preparations
170
43 FACTORS INFLUENCING SUBCUTANEOUS ABSORPTION OF HUMAN INSULIN
178
U40 versus U100 short and intermediateacting insulin preparations
185
shortacting insulins
187

1231 Human cadaveric pancreas
20
1232 Total peptide synthesis
21
1234 Recombinant DNA technology
27
124 SUMMARY
32
Objectives of Investigations
34
Investigational Procedures
36
32 LABORATORY METHODS
38
ClinicalPharmacological Studies
46
411 Study of safety and efficacy of human insulin in normal man
47
412 Comparison of subcutaneous human porcine and bovine insulin in man
55
413 Comparative study of subcutaneous human and porcine insulin in man without the concomitant use of somatostatin
62
414 The influence of somatostatin on the metabolic and hormonal responses to subcutaneous human and porcine insulin
70
415 Doseresponse study of human porcine and bovine insulin
83
416 Comparative study of intravenous and intramuscular administration of human insulin
98
417 A study of intravenous human porcine bovine and intramuscular human insulin in normal man
108
418 A study of the hormonal counterregulatory responses to subcutaneous and intravenous human semisynthetic biosynthetic and porcine insulins
119
intermediateacting insulin study
197
4323 General discussion and summary
202
433 Insulin mixtures
203
4331 Soluble and NPH mixtures
205
4332 Soluble and Lente mixtures
214
4333 Discussion
223
434 Within and between subject variation
224
4341 Soluble insulin U100
226
4342 Lente insulin U100
231
4343 General discussion
236
Summary
237
Acknowledgements
248
Bibliography
250
Index
291
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