{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,13]],"date-time":"2026-07-13T12:10:13Z","timestamp":1783944613332,"version":"3.55.0"},"reference-count":27,"publisher":"American Diabetes Association","issue":"1","content-domain":{"domain":["diabetesjournals.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2003,1,1]]},"abstract":"<jats:p>OBJECTIVE\u2014To evaluate the effects of sibutramine (15 and 20 mg\/day) on weight, metabolic control, and blood pressure in metformin-treated obese subjects with type 2 diabetes.<\/jats:p>\n               <jats:p>RESEARCH DESIGN AND METHODS\u2014A 12-month randomized prospective placebo-controlled double-blind study was performed. It included 21 primary and secondary care centers in England, Canada, France, and Belgium. A total of 195 subjects (44% male) with type 2 diabetes and a BMI &amp;gt;27 kg\/m2 were studied. Changes were assessed in weight, blood pressure and resting heart rate, HbA1c, fasting glucose, and lipids.<\/jats:p>\n               <jats:p>RESULTS\u2014Sibutramine induced significant weight loss (P &amp;lt; 0.001) with both 15 mg\/day (5.5 \u00b1 0.6 kg at 12 months) and 20 mg\/day (8.0 \u00b1 0.9 kg), whereas placebo did not (0.2 \u00b1 0.5 kg). Weight loss \u226510% was achieved by 14 and 27% of subjects receiving 15 and 20 mg, respectively, but by none given placebo. Glycemic control improved in parallel with weight loss, and subjects who lost \u226510% weight showed significant decreases in both HbA1c (1.2 \u00b1 0.4%, P &amp;lt; 0.0001) and fasting plasma glucose (1.8 mmol\/l, P &amp;lt; 0.001). HDL cholesterol increased slightly with the higher dose, whereas plasma triglycerides fell with both doses, especially in subjects with weight loss of \u226510% (a 29% decrease, P &amp;lt; 0.01). Treatment was generally well tolerated. Sibutramine treatment raised sitting diastolic blood pressure by \u22655 mmHg in a higher proportion of patients than did placebo (43% with 15 mg\/day vs. 25% with placebo, P &amp;lt; 0.05), but this effect was less evident in subjects who had a weight loss of \u226510% weight. Pulse rate increased significantly more with sibutramine, being \u226510 bpm higher in 42% of treated patients versus 17% with placebo (P &amp;lt; 0.01).<\/jats:p>\n               <jats:p>CONCLUSIONS\u2014Sibutramine can be an effective adjunct to metformin treatment in selected obese type 2 diabetic subjects and improves metabolic control in individuals who lose weight.<\/jats:p>","DOI":"10.2337\/diacare.26.1.125","type":"journal-article","created":{"date-parts":[[2007,3,5]],"date-time":"2007-03-05T22:51:27Z","timestamp":1173135087000},"page":"125-131","update-policy":"https:\/\/doi.org\/10.2337\/ada-journal-policies","source":"Crossref","is-referenced-by-count":139,"title":["A Randomized Trial of Sibutramine in the Management of Obese Type 2 Diabetic Patients Treated With Metformin"],"prefix":"10.2337","volume":"26","author":[{"given":"Steven J.","family":"McNulty","sequence":"first","affiliation":[{"name":"Diabetes and Endocrinology Research Group, Department of Medicine, University Hospital Aintree, Liverpool, U.K"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ehud","family":"Ur","sequence":"additional","affiliation":[{"name":"Division of Endocrinology, Dalhousie University, Halifax, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gareth","family":"Williams","sequence":"additional","affiliation":[{"name":"Diabetes and Endocrinology Research Group, Department of Medicine, University Hospital Aintree, Liverpool, U.K"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"For the Multicenter Sibutramine Study Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1167","reference":[{"key":"2022031215074169900_R1","doi-asserted-by":"crossref","unstructured":"Colditz G, Willet W, Rotnitzk A, Manson JE: Weight gain as a risk factor for clinical diabetes mellitus in women. Ann Intern Med\u2008122: 481\u2013486, 1995","DOI":"10.7326\/0003-4819-122-7-199504010-00001"},{"key":"2022031215074169900_R2","doi-asserted-by":"crossref","unstructured":"Lew EA, Garfinkel L: Variations in mortality by weight among 750,000 men and women. J Chronic Dis\u200832:563\u2013576, 1979","DOI":"10.1016\/0021-9681(79)90119-X"},{"key":"2022031215074169900_R3","doi-asserted-by":"crossref","unstructured":"Peiris AN, Struve MF, Mueller RA, Lee MB, Kissebah AH: Glucose metabolism in obesity: influence of body fat distribution. J Clin Endocrinol Metab\u200867:760\u2013767, 1988","DOI":"10.1210\/jcem-67-4-760"},{"key":"2022031215074169900_R4","doi-asserted-by":"crossref","unstructured":"Garner DM, Wooley SC: Confronting the failure of behavioural and dietary treatments for obesity. Clin Psychol Rev\u200811:729\u2013780, 1991","DOI":"10.1016\/0272-7358(91)90128-H"},{"key":"2022031215074169900_R5","doi-asserted-by":"crossref","unstructured":"Manson JE, Willett WC, Stampfer MJ, Colditz GA, Hunter DJ, Hankinson SE, Hennekens CH, Speizer FE: Body weight and mortality among women. N Engl J Med\u2008333:677\u2013685, 1995","DOI":"10.1056\/NEJM199509143331101"},{"key":"2022031215074169900_R6","unstructured":"SIGN (Scottish Intercollegiate Guidelines Network): Obesity in Scotland: Integrating Prevention With Weight Management. Edinburgh, U.K., HMSO, 1996"},{"key":"2022031215074169900_R7","doi-asserted-by":"crossref","unstructured":"Wing RR, Shoemaker M, Marcus MDM, McDermott M, Gooding W: Variables associated with weight loss and improvements in glycemic control in type 2 diabetic patients. Arch Intern Med\u2008147:1749\u20131753, 1990","DOI":"10.1001\/archinte.1987.00370100063012"},{"key":"2022031215074169900_R8","unstructured":"Goldstein DJ: Beneficial health effects of modest weight loss. Int J Obes\u200816:397\u2013415, 1992"},{"key":"2022031215074169900_R9","doi-asserted-by":"crossref","unstructured":"Turner RC, Cull CA, Frighi V, Holman RR: Glycemic control with diet, sulphonylureas, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirements for multiple therapies (UKPDS 49): UK Prospective Diabetes Study (UKPDS) Group. JAMA\u200821:2005\u20132012, 1999","DOI":"10.1001\/jama.281.21.2005"},{"key":"2022031215074169900_R10","doi-asserted-by":"crossref","unstructured":"Scheen AJM, Paolisso G, Salvatore T, Lefe\u0300bvre PJ: Improvement of insulin-induced glucose disposal in obese patients with NIDDM after one week treatment of d-fenfluramine. Diabetes Care\u200814:325\u2013332, 1991","DOI":"10.2337\/diacare.14.4.325"},{"key":"2022031215074169900_R11","doi-asserted-by":"crossref","unstructured":"Hollander PA, Elbein SC, Hirsch IB, Kelley D, McGill J, Taylor T, Weiss SR, Crockett SE, Kaplan RA, Comstock J, Lucas CP, Lodewick PA, Canovatchel W, Chung J, Hauptman J: Role of orlistat in the treatment of obese patients with type 2 diabetes: a 1-year randomized double-blind study. Diabetes Care\u200821:1288\u20131294, 1998","DOI":"10.2337\/diacare.21.8.1288"},{"key":"2022031215074169900_R12","unstructured":"Heal DJ, Aspley S, Prow MR, Jackson HC, Martin KF, Cheetham SC: Sibutramine: a novel anti-obesity drug: a review of the pharmacological evidence to differentiate it from d-amphetamine and d-fenfluramine. Int J Obes\u200822:S18\u2013S29, 1998"},{"key":"2022031215074169900_R13","doi-asserted-by":"crossref","unstructured":"Fujioka K, Seaton TB, Rowe E, Jelinek CA, Raskin P, Lebovitz HE, Weinstein SP: Weight loss with sibutramine improves glycemic control and other metabolic parameters in obese patients with type 2 diabetes mellitus. Diabetes Obes Metab\u20082:175\u2013187, 2000","DOI":"10.1046\/j.1463-1326.2000.00081.x"},{"key":"2022031215074169900_R14","doi-asserted-by":"crossref","unstructured":"Han TS, van Leer EM, Seidell JC, Lean MEJ: Waist circumference action levels in the identification of cardiovascular risk factors: prevalence study in a random sample. BMJ\u2008311:1401\u20131405, 1995","DOI":"10.1136\/bmj.311.7017.1401"},{"key":"2022031215074169900_R15","doi-asserted-by":"crossref","unstructured":"Nagi DK, Yudkin JS: Effects of metformin on insulin resistance, risk factors for cardiovascular disease, and plasminogen activator inhibitor in NIDDM subjects. Diabetes Care\u200816:621\u2013628, 1993","DOI":"10.2337\/diacare.16.4.621"},{"key":"2022031215074169900_R16","doi-asserted-by":"crossref","unstructured":"Lean MEJ, Powrie JK, Anderson AS, Garthwaite PH: Obesity, weight loss and prognosis in type 2 diabetes. Diabet Med\u20087:228\u2013233, 1990","DOI":"10.1111\/j.1464-5491.1990.tb01375.x"},{"key":"2022031215074169900_R17","doi-asserted-by":"crossref","unstructured":"UK Prospective Diabetes Study (UKPDS) Group: Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet\u2008352:854\u2013865, 1998","DOI":"10.1016\/S0140-6736(98)07037-8"},{"key":"2022031215074169900_R18","doi-asserted-by":"crossref","unstructured":"Lee IM, Paffenbarger RS: Changes in body weight and longevity. JAMA\u2008268:2045\u20132049, 1992","DOI":"10.1001\/jama.268.15.2045"},{"key":"2022031215074169900_R19","unstructured":"Wing RR: Improving dietary adherence in patients with diabetes. In Nutrition and Diabetes. Jovanovic L, Peterson CM, Eds. New York, Alan R. Liss, 1995, p. 161\u2013186"},{"key":"2022031215074169900_R20","doi-asserted-by":"crossref","unstructured":"Balfour JA, Plosker GL: Rosiglitazone. Drugs\u200857:921\u2013930, 1999","DOI":"10.2165\/00003495-199957060-00007"},{"key":"2022031215074169900_R21","doi-asserted-by":"crossref","unstructured":"James WP, Astrup A, Finer N, Hilsted J, Kopelman P, Rossner S, Saris WH, Van Gaal LF, for the STORM study group: Effect of sibutramine on weight maintenance after weight loss: a randomised trial. Lancet\u2008356:2119\u20132125, 2000","DOI":"10.1016\/S0140-6736(00)03491-7"},{"key":"2022031215074169900_R22","unstructured":"Poirier P, Despre\u0301s J-P: Lipid disorders in diabetes mellitus. In Textbook of Diabetes. 3rd ed. Pickup J, Williams G, Eds. Oxford, U.K., Blackwell Science, 2002, p. 54.1\u201354.29"},{"key":"2022031215074169900_R23","doi-asserted-by":"crossref","unstructured":"UK Prospective Diabetes Study Group: Tight blood pressure and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ\u2008317:703\u2013713, 1998","DOI":"10.1136\/bmj.317.7160.703"},{"key":"2022031215074169900_R24","doi-asserted-by":"crossref","unstructured":"Lehmann ED, Gosling RG, So\u0308nksen PH: Arterial wall compliance in diabetes. Diabet Med\u20089:114\u2013119, 1992","DOI":"10.1111\/j.1464-5491.1992.tb01746.x"},{"key":"2022031215074169900_R25","doi-asserted-by":"crossref","unstructured":"Anderson KM, Wilson PW, Odell PM, Kannel WB: An updated coronary risk profile: a statement for health professionals. Circulation\u200883:356\u2013362, 1991","DOI":"10.1161\/01.CIR.83.1.356"},{"key":"2022031215074169900_R26","unstructured":"Assmann G, Culler P, Schu\u0308lte H: The Munster heart study (PROCAM): results of follow-up at 8 years. Eur Heart J\u200819 (Suppl. A):A2\u2013A11, 1998"},{"key":"2022031215074169900_R27","unstructured":"Palatini P: Elevated heart rate as a predictor of increased cardiovascular morbidity. J Hypertens\u200817 (Suppl. 3)S3\u2013S10, 1999"}],"container-title":["Diabetes Care"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/diabetesjournals.org\/care\/article-pdf\/26\/1\/125\/648139\/dc0103000125.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/diabetesjournals.org\/care\/article-pdf\/26\/1\/125\/648139\/dc0103000125.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,3,12]],"date-time":"2022-03-12T15:07:56Z","timestamp":1647097676000},"score":1,"resource":{"primary":{"URL":"https:\/\/diabetesjournals.org\/care\/article\/26\/1\/125\/22551\/A-Randomized-Trial-of-Sibutramine-in-the"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2003,1,1]]},"references-count":27,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2003,1,1]]}},"URL":"https:\/\/doi.org\/10.2337\/diacare.26.1.125","relation":{},"ISSN":["0149-5992","1935-5548"],"issn-type":[{"value":"0149-5992","type":"print"},{"value":"1935-5548","type":"electronic"}],"subject":[],"published":{"date-parts":[[2003,1,1]]}}}