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A double-blind crossover trial comparing human insulin (recombinant DNA) with animal insulins in the treatment of previously insulin-treated diabetic patients. 1982

A J Clark, and P G Wiles, and J M Leiper, and G Knight, and R O Adeniyl-Jones, and P J Watkins, and J D Ward, and A C MacCuish, and H Keen, and R H Jones

Ninety-four diabetic patients established on treatment with pork (N = 47) or beef insulin (N = 47) took part in a double-blind crossover trial in which 6-wk treatment periods of their animal insulin were compared with similar periods on human insulin (recombinant DNA). Six patients withdrew during the trial--in three cases for hypoglycemia while taking human insulin. In patients initially treated with beef insulin there was no significant change in the mean blood glucose, the 'M' index, the total daily insulin dose, or the frequency of hypoglycemic attacks after the change to human insulin. Home blood glucose sample values were greater before the morning and evening insulin injection on human insulin (morning: 12.8 mmol/L [beef] versus 14.2 mmol/L [human insulin] [P less than 0.05]; evening: 10.0 mmol/L versus 11.6 mmol/L [P = 0.05]). In pork insulin-treated patients greater values while on human insulin were found for mean glucose (9.0 mmol/L [pork] versus 9.7 mmol/L [human insulin], P = 0.05), 'M' index (65.0 [pork] versus 79.6 [human insulin], P less than 0.025), and total daily insulin dose (50.9 U/day [pork] versus 52.5 U/day [human insulin], P less than 0.001). The early morning glucose sample was also greater on human insulin (9.6 mmol/L [pork] versus 12.1 mmol/L [human insulin], P less than 0.001). No significant differences in either insulin antibody levels or E. coli protein antibody levels were found between either of the animal-insulin treatment periods and human insulin treatment periods.(ABSTRACT TRUNCATED AT 250 WORDS)

UI MeSH Term Description Entries
D007328 Insulin A 51-amino acid pancreatic hormone that plays a major role in the regulation of glucose metabolism, directly by suppressing endogenous glucose production (GLYCOGENOLYSIS; GLUCONEOGENESIS) and indirectly by suppressing GLUCAGON secretion and LIPOLYSIS. Native insulin is a globular protein comprised of a zinc-coordinated hexamer. Each insulin monomer containing two chains, A (21 residues) and B (30 residues), linked by two disulfide bonds. Insulin is used as a drug to control insulin-dependent diabetes mellitus (DIABETES MELLITUS, TYPE 1). Iletin,Insulin A Chain,Insulin B Chain,Insulin, Regular,Novolin,Sodium Insulin,Soluble Insulin,Chain, Insulin B,Insulin, Sodium,Insulin, Soluble,Regular Insulin
D007336 Insulin, Isophane An intermediate-acting INSULIN preparation with onset time of 2 hours and duration of 24 hours. It is produced by crystallizing ZINC-insulin-PROTAMINES at neutral pH 7. Thus it is called neutral protamine Hagedorn for inventor Hans Christian Hagedorn. Insulin, NPH,Insulin, Protamine Zinc,Isophane Insulin, Regular,NPH Insulin,Neutral Protamine Hagedorn Insulin,Protamine Hagedorn Insulin,Hagedorn Insulin, Protamine,Isophane Insulin,Protamine Zinc Insulin,Regular Isophane Insulin,Zinc Insulin, Protamine
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D011897 Random Allocation A process involving chance used in therapeutic trials or other research endeavor for allocating experimental subjects, human or animal, between treatment and control groups, or among treatment groups. It may also apply to experiments on inanimate objects. Randomization,Allocation, Random
D011994 Recombinant Proteins Proteins prepared by recombinant DNA technology. Biosynthetic Protein,Biosynthetic Proteins,DNA Recombinant Proteins,Recombinant Protein,Proteins, Biosynthetic,Proteins, Recombinant DNA,DNA Proteins, Recombinant,Protein, Biosynthetic,Protein, Recombinant,Proteins, DNA Recombinant,Proteins, Recombinant,Recombinant DNA Proteins,Recombinant Proteins, DNA
D002417 Cattle Domesticated bovine animals of the genus Bos, usually kept on a farm or ranch and used for the production of meat or dairy products or for heavy labor. Beef Cow,Bos grunniens,Bos indicus,Bos indicus Cattle,Bos taurus,Cow,Cow, Domestic,Dairy Cow,Holstein Cow,Indicine Cattle,Taurine Cattle,Taurus Cattle,Yak,Zebu,Beef Cows,Bos indicus Cattles,Cattle, Bos indicus,Cattle, Indicine,Cattle, Taurine,Cattle, Taurus,Cattles, Bos indicus,Cattles, Indicine,Cattles, Taurine,Cattles, Taurus,Cow, Beef,Cow, Dairy,Cow, Holstein,Cows,Dairy Cows,Domestic Cow,Domestic Cows,Indicine Cattles,Taurine Cattles,Taurus Cattles,Yaks,Zebus
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D003922 Diabetes Mellitus, Type 1 A subtype of DIABETES MELLITUS that is characterized by INSULIN deficiency. It is manifested by the sudden onset of severe HYPERGLYCEMIA, rapid progression to DIABETIC KETOACIDOSIS, and DEATH unless treated with insulin. The disease may occur at any age, but is most common in childhood or adolescence. Diabetes Mellitus, Brittle,Diabetes Mellitus, Insulin-Dependent,Diabetes Mellitus, Juvenile-Onset,Diabetes Mellitus, Ketosis-Prone,Diabetes Mellitus, Sudden-Onset,Diabetes, Autoimmune,IDDM,Autoimmune Diabetes,Diabetes Mellitus, Insulin-Dependent, 1,Diabetes Mellitus, Type I,Insulin-Dependent Diabetes Mellitus 1,Juvenile-Onset Diabetes,Type 1 Diabetes,Type 1 Diabetes Mellitus,Brittle Diabetes Mellitus,Diabetes Mellitus, Insulin Dependent,Diabetes Mellitus, Juvenile Onset,Diabetes Mellitus, Ketosis Prone,Diabetes Mellitus, Sudden Onset,Diabetes, Juvenile-Onset,Diabetes, Type 1,Insulin Dependent Diabetes Mellitus 1,Insulin-Dependent Diabetes Mellitus,Juvenile Onset Diabetes,Juvenile-Onset Diabetes Mellitus,Ketosis-Prone Diabetes Mellitus,Sudden-Onset Diabetes Mellitus
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked

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