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A Clinical Trial of Carbutamide (Bz 55) in the Diabetic Clinic

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A Clinical Trial of Carbutamide (Bz 55) in the Diabetic Clinic 22 besember 1956 S.A. TYDSKRIF VIR GENEESKUNDE 1227 Carbutamide may sometimes potentiate the effect of is effective in mild diabetes of 'maturity onset' is sub­ barbiturate and of alcohol, and patients should be stantiated. In obese patients dietary restriction remains warned of this possibility. of primary importance. In our series, as in others, there was no change in 3. The possible place of carbutamide (or its suc­ the blood urea, serum protein, thymol turbidity, thymol cessor) in severe diabetes of growth onset is considered. flocculation, zinc turbidity, serum bilirubin or serum It cannot replace insulin completely but it certainly Van den Berg reaction. seems more active in these cases than is usually believed. • 4. Toxic effects are potentially serious. SUMMARY We are indebted to all the physicians and other members of 1. A clinical trial of carbutamide in diabetes mellitus the staff of the hospital who cooperated in this trial. was undertaken in the wards on a short-term basis. 2. The claim of other observers that carbutamide For references see end of the following paper (page 1230). A CLINICAL TRIAL OF CARBUTAMIDE (BZ 55) IN THE DIABETIC CLINIC W. P. U. JACKSON, M.D., M.R.C.P., G. C. LIl'o.'DER, M.D., F.R.C.P., JOSEPH B. HERMAN, B.Sc., M.B., CH.B., R. HOFFENBERG, M.B., M.R.C.P., M. J. BAILEY, M.B., M.R.C.P., R. WEINBERG, M.B., CH.B., and I. GRAYCE, M.B., M.R.C.P. From the Diabetic Clinic, Department ofMedicine, Groote Schuur Hospital and the University of Cape Town While the previous paper describes our more detailed more liberal diet was allowed. As far as possible all observations on a small number of in-patients treated patients in the trial were seen weekly and had weekly with carbutamide, this one considers the larger number fasting capillary blood-sugar estimations. As well as of diabetics treated as out-patients. - this, the control was followed by collections of 24-hour urine once a week, by 50 g. oral glucose-tolerance Methods curves before, during and after carbutamide the~apy, This series comprises 31 patients in all, excluding those who were first investigated in the ward. All but R.L. [.F. 60 55/11486 PH. [.F. 59 150234 3 were the 'mild maturity-onset' type of diabetic, who 2BO -,--,..-="..--,-,-,,---;:-----, 320 -,--------..,.-..,.-, had previously been treated with small doses of insulin 240 _ or diet only. There were 2 severe diabetics, who were BLOOD liable to ketosis, and one of intermediate severity. SUGAR 200 In general, any insulin which was being used was ..g. 160 stopped some weeks before carbutamide was tried. por 100 The diet was not usually altered, but in a few cases a 120 ..I. RL. [.F.60 55/11486 BO 120 ~C~41~(-------7:70--------7) o 0·5 1'0 1'5 2'0 0 0·5 1·0 1·5 2-0 WEIGHT 155 TIME IN HOURS T TIME IN HOURS lb. ."-... _._-.---------_.... i 150 ............/ . 5OGM. G~c'b~'E BZ-55 3 (;LUC05[ 18 28 grams I L Fig. lB. R.L., same patient as Fig. lA. (I) 16 August 1956, on BZ 55 for 5 weeks. (2) 4 October 1956, off BZ 55 for 6 F.B.S. 150 weeks. Her glucose-tolerance curve was far lower while on -gm pcr .--------------.. the drug. 100 100 .-~.-'- Fig. 2B. P.H., same patient as Fig. 2A. (I) 23 August 1956, -I. ~##' I week beforeBZ 55. (2) 2 October 1956, on BZ 55 for 5 weeks. An improvement in tbe glucose·tolerance curve while under 50 carbutamide is evident, but the tolerance curve is still grossly URINE L--------~) SUGAR ('-(-------- NI abnormal. 28 S '12 19 26 2 9 16 23 30 6 13 20 27 4 JUNE JULY AUG. SEPT. OCT . INSULIN: NI~ 1A or simply by qualitative urine-tests. The total white cells were counted before and during therapy, and in Fig. IA.* R.L. A non-obese, mild diabetic with high renal many cases the serum cholesterol, blood urea and liver threshold. On a larger intake, her fasting sugar gradually diminished with carbuiamide, and rose after its discontinu­ function· were estimated before and after 4 weeks of ance. carbutamide. The dosage of carbutamide was the standard one of * Conventions regarding figures as in the preceding paper (see footnote on p. 1223, second column). The shaded portion of the 2t g. the first day, 1t g. the next day and 1 g. thereafter. glucose-tolerance graphs indicates the abnormal, diabetic zone. The day's ration of tablets were taken all together in 1228 S.A. MEDICAL JOURNAL 22 December 1956 SERUM I E.C. E.F. 5& 57019 P.H. EF.59 150234 CHOLESI£AOC 269 -911l per SERUM 1001111. 170 ~~~;~ ~ 5 ....---------------- lb. 16 WEIGHT 115 / 160 lb. 110 ~ 3 ._--------­ ~roln:s I • 200 ~ L ""lm p<r 150 100 al. 100 20 24-HR. IS 150 URINE SUGAR 10 ogforas 5 100 162330613 20 27 .. 11 ~-----_----N 1 L-------~----+ AUG. SEPT. OCT' 24 31 7 '4 21 2S 5 12 19 26 2 9 16 23 30 6 13 20 27 4 Q!il: FULL INSULIN: NIL 2A MAY .JUNE .JULY AUG. SEPT. ~ ~: CHO 97 gra•• Fig. 2A. P.H. A thin female whose diabetes was Fig. 3A. E.C. A non-obese diabetic of 5 years' standing, with high renal of 5 years' duration. We encouraged her to eat threshold, in whom oral 'Diabeton't together with her insulin did not lower everything. The improvement in fasting sugar and urinary sugar while on carbutamide is evident. the fasting sugar, while carbutamide was effective with no insulin. the mornings. The 50 g. oral glucose-tolerance tests responded by giving average or over-all data. For were performed on patients who had taken a high this reason the data from 5 typical mild cases are carbohydrate diet for 1 week; capillary blood was charted (Figs. 1-5). In order to express a 'mean' re­ used, and the modified Hagedorn-Jensen method of sponse also, the last 3 blood-sugar readings before estimation. carbutamide and the first 3 while on the drug in all 28 patients have been averaged. Before carbutamide Results the mean blood-sugar reading was 182 mg. per 100 ml. Of the 28 'mild' cases all but 3 showed a distinct (standard deviation=45); while taking this drug it was response by reduction of blood sugar on repeated P.E. E.F. 57 56/07525 occasions together with reduction of urine sugar or SERUM improvement of glucose tolerance. In some of the C~if~PQL:I 382 newly diagnosed patients there was also symptomatic 100.,1. improvement of such complaints as pruritus vulvae DIET ~RESTRICTED CHo~I~(----FUlt.:----~) and loss of energy. WEIGHT 125 It is not easy to express clearly just how patients -Ib-.- 120 ----.--.-----------. E.C. Er. 58 57089 M.L. C...... 160031 8Z-55 3 3'10 340 grolDs 1 .... ....- __ 300 300 "F.B.S?OO ~__"'\ BLOOD 260 SUGAR 260 mg. 220 pcr 220 100 180 100 001. 180 24 HR. 140 URINE 5 140 +-+--,----.--,--,r-.-.....:4 SUGAR 100 -r--r--.--.-.--.,-.-r-l grams 0'5 1-0 1'5 o 2-0 o os 1'0 1'5 12 19 26 2 9 16 23 30 6 13 20 27 4 T TIME IN HOURS T TIME IN HOURS JULY AUG. SEPT. OCl 50GM. SOGM. Nil GLUCOSE 38 GLUCOSE 5 4 Fig. 4. P.E. A thin woman with mild diabetes of 8 years' standing, who had taken insulin for 6 years. C<!.rbutamide Fig. 3B. E.C., same patient as Fig. 3A. 2 October 1956, after 10 weeks on BZ 55. Notwithstanding the improvement was highly efficacious in lowering the fasting blood-sugar and in the fasting sugar while under carbutamide, the single 24-bour urine-sugar, even in dosage of t g. per day.• toleraoce curve taken during its administration is neverthe­ t 'Diabeton-M' is a proprietary preparation claiming to be less grossly abnormal. extremely effective in controlling all types of diabetes. It Fig. 5. M.L. An obese diabetic of I year's standing. Not contains 5 hydroxyanthranilic acid, vitamin B6, methionine, on insulin. (I) 12 June 1956, before starting any drug..(2) vitamin C, and a mysterious Japanese extract of 'Morus 13 July 1956, after I month on 'Diabeton'. (3) 4 September Bombycio Koidzumi (Moraceae)'. It appears, from our 1956, after I month on BZ 55. There was,,: distinct improve­ limited observations on this preparation, that it may occasion­ ment of glucose-tolerance on 'Diabetbn', but a considerably ally have some blood-sugar lowering effect, but not com­ greater improvement on carbutamide. parable to that of carbutamide. 22 I>esenrrber 1956 S.A. TYDSKRIF VIR GENEESKUNDE 1229 124 (S.D.=46). The difference between these two We noticed a tendency to relapse in some instances, means is highly significant (p= > '(01). At the same even while the patient was still maintained on the drug, time it must be pointed out that a mean figure of 124 as judged by an increase in the fasting sugar. After signifies that in many individuals the fasting blood­ the BZ 55 was discontinued the control of the diabetes sugar was still too high. usually worsened, but not always immediately. There The 3 'mild' diabetics who did not respond at all was no instance of the final state being worse than were not distinguished by any obvious specific char­ before the treatment. Of course we do not know what acteristics.
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