{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T00:41:14Z","timestamp":1789605674786,"version":"build-2803163510"},"reference-count":35,"publisher":"American Diabetes Association","issue":"3","content-domain":{"domain":["diabetesjournals.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2003,3,1]]},"abstract":"<jats:p>OBJECTIVE\u2014Mealtime amylin replacement with the human amylin analog pramlintide, as an adjunct to mealtime insulin replacement, reduces postprandial glucose excursions in patients with type 2 diabetes. The aim of the present study was to assess the long-term efficacy and safety of pramlintide in this patient population.<\/jats:p>\n               <jats:p>RESEARCH DESIGN AND METHODS\u2014In a 52-week, double-blind, placebo-controlled, parallel-group, multicenter study, 656 patients with type 2 diabetes (age 57 \u00b1 10 years, diabetes duration 12 \u00b1 7 years, BMI 34.0 \u00b1 7.0 kg\/m2, HbA1c 9.1 \u00b1 1.2%, mean \u00b1 SD) treated with insulin (alone or in combination with sulfonylureas and\/or metformin) were randomized to receive additional preprandial subcutaneous injections of either placebo or pramlintide (60 \u03bcg TID, 90 \u03bcg BID, or 120 \u03bcg BID).<\/jats:p>\n               <jats:p>RESULTS\u2014Treatment with pramlintide 120 \u03bcg BID led to a sustained reduction from baseline in HbA1c (\u22120.68 and \u22120.62% at weeks 26 and 52, respectively), which was significantly greater than that seen with placebo (P &amp;lt; 0.05). The proportion of patients achieving an HbA1c &amp;lt;8% was approximately twofold greater with pramlintide (120 \u03bcg BID) than with placebo (46 vs. 28%, P &amp;lt; 0.05). The glycemic improvement with pramlintide 120 \u03bcg BID was accompanied by a mean weight loss (\u22121.4 kg vs. +0.7 kg with placebo at week 52, P &amp;lt; 0.05) and occurred without an overall increase in the severe hypoglycemia event rate. The most common adverse event associated with pramlintide use was transient, mild-to-moderate nausea.<\/jats:p>\n               <jats:p>CONCLUSIONS\u2014Mealtime amylin replacement with pramlintide 120 \u03bcg BID, as an adjunct to insulin therapy, improves long-term glycemic and weight control in patients with type 2 diabetes.<\/jats:p>","DOI":"10.2337\/diacare.26.3.784","type":"journal-article","created":{"date-parts":[[2007,3,5]],"date-time":"2007-03-05T22:51:27Z","timestamp":1173135087000},"page":"784-790","update-policy":"https:\/\/doi.org\/10.2337\/ada-journal-policies","source":"Crossref","is-referenced-by-count":262,"title":["Pramlintide as an Adjunct to Insulin Therapy Improves Long-Term Glycemic and Weight Control in Patients With Type 2 Diabetes"],"prefix":"10.2337","volume":"26","author":[{"given":"Priscilla A.","family":"Hollander","sequence":"first","affiliation":[{"name":"Baylor University Medical Center, Dallas, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip","family":"Levy","sequence":"additional","affiliation":[{"name":"Phoenix Endocrinology Clinic, Phoenix, Arizona"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark S.","family":"Fineman","sequence":"additional","affiliation":[{"name":"Amylin Pharmaceuticals, Inc., San Diego, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David G.","family":"Maggs","sequence":"additional","affiliation":[{"name":"Amylin Pharmaceuticals, Inc., San Diego, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Larry Z.","family":"Shen","sequence":"additional","affiliation":[{"name":"Amylin Pharmaceuticals, Inc., San Diego, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan A.","family":"Strobel","sequence":"additional","affiliation":[{"name":"Amylin Pharmaceuticals, Inc., San Diego, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Weyer","sequence":"additional","affiliation":[{"name":"Amylin Pharmaceuticals, Inc., San Diego, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Orville G.","family":"Kolterman","sequence":"additional","affiliation":[{"name":"Amylin Pharmaceuticals, Inc., San Diego, California"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1167","reference":[{"key":"2022031220325617200_R1","doi-asserted-by":"crossref","unstructured":"UK Prospective Diabetes Study (UKPDS) Group: Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes. Lancet\u2008352: 837\u2013853, 1998","DOI":"10.1016\/S0140-6736(98)07019-6"},{"key":"2022031220325617200_R2","doi-asserted-by":"crossref","unstructured":"UK Prospective Diabetes Study Group: Overview of 6 years therapy of type II diabetes: a progressive disease. Diabetes\u200844: 1249\u20131258, 1995","DOI":"10.2337\/diabetes.44.11.1249"},{"key":"2022031220325617200_R3","doi-asserted-by":"crossref","unstructured":"Klein R, Klein BE, Moss SE, Cruickshanks KJ: The medical management of hyperglycemia over a 10-year period in people with diabetes. Diabetes Care\u200819: 744\u2013750, 1996","DOI":"10.2337\/diacare.19.7.744"},{"key":"2022031220325617200_R4","doi-asserted-by":"crossref","unstructured":"Henry RR, Gumbiner B, Ditzler T, Wallace P, Lyon R, Glauber HS: Intensive conventional insulin therapy for type II diabetes: metabolic effects during a 6-mo outpatient trial. Diabetes Care\u200816: 21\u201331, 1993","DOI":"10.2337\/diacare.16.1.21"},{"key":"2022031220325617200_R5","doi-asserted-by":"crossref","unstructured":"Riddle MC: Should obese type 2 diabetic patients be treated with insulin? In Difficult Diabetes. Gill GV, Pickup JC, Williams G, Eds. Oxford, Blackwell Science, 2001, p. 94\u2013112","DOI":"10.1002\/9780470757109.ch7"},{"key":"2022031220325617200_R6","unstructured":"Purnell JQ, Weyer C: Weight effect of current and experimental diabetes drugs: from promotion to alleviation of obesity. Treatments Endocrinol\u200821: 23\u201337, 2003"},{"key":"2022031220325617200_R7","doi-asserted-by":"crossref","unstructured":"American Diabetes Association: Postprandial blood glucose (Consensus Statement). Diabetes Care\u200824: 775\u2013778, 2001","DOI":"10.2337\/diacare.24.4.775"},{"key":"2022031220325617200_R8","doi-asserted-by":"crossref","unstructured":"Lebovitz HE: Postprandial hyperglycaemic state: importance and consequences (Review Article). Diabetes Res Clin Pract\u200840 (Suppl.): S27\u2013S28, 1998","DOI":"10.1016\/S0168-8227(98)00039-4"},{"key":"2022031220325617200_R9","doi-asserted-by":"crossref","unstructured":"Gurlek A, Erbas T, Gedik O: Frequency of severe hypoglycaemia in type 1 and type 2 diabetes during conventional insulin therapy. Exp Clin Endocrinol Diabetes\u2008107: 220\u2013224, 1999","DOI":"10.1055\/s-0029-1212102"},{"key":"2022031220325617200_R10","doi-asserted-by":"crossref","unstructured":"Jaap AJ, Jones GC, McCrimmon RJ, Deary IJ, Frier BM: Perceived symptoms of hypoglycaemia in elderly type 2 diabetic patients treated with insulin. Diabet Med\u200815: 398\u2013401, 1998","DOI":"10.1002\/(SICI)1096-9136(199805)15:5<398::AID-DIA595>3.0.CO;2-B"},{"key":"2022031220325617200_R11","doi-asserted-by":"crossref","unstructured":"Hepburn DA, MacLeod KM, Pell AC, Scougal IJ, Frier BM: Frequency and symptoms of hypoglycaemia experienced by patients with type 2 diabetes treated with insulin. Diabet Med\u200810: 231\u2013237, 1993","DOI":"10.1111\/j.1464-5491.1993.tb00050.x"},{"key":"2022031220325617200_R12","unstructured":"Koda JE, Fineman MS, Kolterman OG, Caro JF: 24 hour plasma amylin profiles are elevated in IGT subjects vs. normal controls (Abstract). Diabetes\u200844 (Suppl. 1): 238A, 1995"},{"key":"2022031220325617200_R13","doi-asserted-by":"crossref","unstructured":"Weyer C, Maggs DG, Young AA, Kolterman OG: Amylin replacement with pramlintide as an adjunct to insulin therapy in type 1 and\/type 2 diabetes mellitus: a physiological approach toward improved metabolic control. Curr Pharm Des\u20087: 1353\u20131373, 2001","DOI":"10.2174\/1381612013397357"},{"key":"2022031220325617200_R14","doi-asserted-by":"crossref","unstructured":"Edelman SV, Weyer C: Unresolved challenges with insulin therapy in type 1 and type 2 diabetes: potential benefit of replacing amylin, a second \u03b2-cell hormone. Diabetes Technol Ther\u20084: 175\u2013189, 2002","DOI":"10.1089\/15209150260007390"},{"key":"2022031220325617200_R15","doi-asserted-by":"crossref","unstructured":"Buse JB, Weyer C, Maggs DG: Amylin replacement with pramlintide in type 1 and type 2 diabetes: a physiological approach to overcome barriers with insulin therapy. Clinical Diabetes\u200820: 137\u2013144, 2002","DOI":"10.2337\/diaclin.20.3.137"},{"key":"2022031220325617200_R16","unstructured":"Fineman MS, Giotta MP, Thompson RG, Kolterman OG, Koda JE: Amylin response following Sustacal\u00ae ingestion is diminished in type II diabetic patients treated with insulin (Abstract). Diabetologia\u200839 (Suppl. 1): A149, 1996"},{"key":"2022031220325617200_R17","unstructured":"Young A, Moore C, Herich J, Beaumont K: Neuroendocrine actions of amylin. In The CGRP Family: Calcitonin Gene-Related Peptide (CGRP), Amylin, and Adrenomedullin. Poyner D, Marshall I, Brain SD, Eds. Georgetown, Texas, Landes Bioscience, 2000, p. 91\u2013102"},{"key":"2022031220325617200_R18","doi-asserted-by":"crossref","unstructured":"Gedulin BR, Rink TJ, Young AA: Dose-response for glucagonostatic effect of amylin in rats. Metabolism\u200846: 67\u201370, 1997","DOI":"10.1016\/S0026-0495(97)90170-0"},{"key":"2022031220325617200_R19","doi-asserted-by":"crossref","unstructured":"Young AA, Gedulin B, Vine W, Percy A, Rink TJ: Gastric emptying is accelerated in diabetic BB rats and is slowed by subcutaneous injections of amylin. Diabetologia\u200838: 642\u2013648, 1995","DOI":"10.1007\/BF00401833"},{"key":"2022031220325617200_R20","doi-asserted-by":"crossref","unstructured":"Fineman M, Weyer C, Maggs DG, Strobel S, Kolterman O: The human amylin analog, pramlintide, reduces postprandial hyperglucagonemia in patients with type 2 diabetes mellitus. Horm Metab Res\u200834: 504\u2013508, 2002","DOI":"10.1055\/s-2002-34790"},{"key":"2022031220325617200_R21","doi-asserted-by":"crossref","unstructured":"Vella A, Lee JS, Camilleri M, Szarka LA, Burton DD, Zinsmeister AR, Rizza RA, Klein PD: Effects of pramlintide, an amylin analogue, on gastric emptying in type 1 and type 2 diabetes mellitus. Neurogastroenterol Motil\u200814: 123\u2013131, 2002","DOI":"10.1046\/j.1365-2982.2002.00311.x"},{"key":"2022031220325617200_R22","unstructured":"Maggs DG, Weyer C, Crean J, Wang Y, Burrell T, Finemam M, Kornstein J, Schwartz S, Guiterrez M, Kolterman O: Mealtime amylin replacement with pramlintide markedly improves postprandial glucose excursions when added to insulin lispro in patients with type 2 diabetes: a dose-timing study (Abstract). Diabetologia\u2008(Suppl. 2)45: A264, 2002"},{"key":"2022031220325617200_R23","doi-asserted-by":"crossref","unstructured":"Thompson RG, Gottlieb A, Organ K, Koda J, Kisicki J, Kolterman OG: Pramlintide: a human amylin analogue reduced postprandial plasma glucose, insulin and C-peptide concentrations in patients with type II diabetes. Diabet Med\u200814: 547\u2013555, 1997","DOI":"10.1002\/(SICI)1096-9136(199707)14:7<547::AID-DIA390>3.0.CO;2-U"},{"key":"2022031220325617200_R24","doi-asserted-by":"crossref","unstructured":"American Diabetes Association: Standards of medical care for patients with diabetes mellitus (Position Statement). Diabetes Care\u200825 (Suppl. 1): S33\u2013S49, 2002","DOI":"10.2337\/diacare.25.2007.S33"},{"key":"2022031220325617200_R25","doi-asserted-by":"crossref","unstructured":"DCCT Research Group: Epidemiology of severe hypoglycemia in the Diabetes Control and Complications Trial. Am J Med\u200890: 450\u2013459, 1991","DOI":"10.1016\/0002-9343(91)90605-W"},{"key":"2022031220325617200_R26","doi-asserted-by":"crossref","unstructured":"Ratner RE, Want LL, Fineman MS, Velte MJ, Ruggles JA, Gottlieb A, Weyer C, Kolterman OG: Adjunctive therapy with the amylin analogue pramlintide leads to a combined improvement in glycemic and weight control in insulin-treated patients with type 2 diabetes. Diabetes Technol Ther\u20084: 51\u201361, 2002","DOI":"10.1089\/15209150252924094"},{"key":"2022031220325617200_R27","doi-asserted-by":"crossref","unstructured":"Garber AJ, Duncan TG, Goodman AM, Mills DJ, Rohlf JL: Efficacy of metformin in type II diabetes: results of a double-blind, placebo-controlled, dose-response trial. Am J Med\u2008103: 491\u2013497, 1997","DOI":"10.1016\/S0002-9343(97)00254-4"},{"key":"2022031220325617200_R28","doi-asserted-by":"crossref","unstructured":"Aviles-Santa L, Sinding J, Raskin P: Effects of metformin in patients with poorly controlled, insulin-treated type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled trial. Ann Intern Med\u2008131: 182\u2013188, 1999","DOI":"10.7326\/0003-4819-131-3-199908030-00004"},{"key":"2022031220325617200_R29","doi-asserted-by":"crossref","unstructured":"Morley JE, Flood JF: Amylin decreases food intake in mice. Peptides\u200812: 865\u2013869, 1991","DOI":"10.1016\/0196-9781(91)90148-I"},{"key":"2022031220325617200_R30","doi-asserted-by":"crossref","unstructured":"Rushing PA, Hagan MM, Seeley RJ, Lutz TA, D\u2019Alessio DA, Air EL, Woods SC: Inhibition of central amylin signaling increases food intake and body adiposity in rats. Endocrinology\u2008142: 5035\u20135038, 2001","DOI":"10.1210\/endo.142.11.8593"},{"key":"2022031220325617200_R31","doi-asserted-by":"crossref","unstructured":"Hollander PA, Elbein SC, Hirsch IB, Kelley D, McGill J, Taylor T, Weiss SR, Crockett SC, 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":"2022031220325617200_R32","doi-asserted-by":"crossref","unstructured":"Finer N, Bloom SR, Frost GS, Banks LM, Griffiths J: Sibutramine is effective for weight loss and diabetic control in obesity with type 2 diabetes: a randomized, double-blind, placebo-controlled study. Diabetes Obes Metab\u20082: 105\u2013112, 2000","DOI":"10.1046\/j.1463-1326.2000.00071.x"},{"key":"2022031220325617200_R33","unstructured":"Gottlieb A, Velte M, Fineman M, Kolterman O: Pramlintide as an adjunct to insulin therapy improved glycemic and weight control in people with type 1 diabetes during treatment for 52 weeks (Abstract). Diabetes\u200849 (Suppl. 1): A109, 2000"},{"key":"2022031220325617200_R34","doi-asserted-by":"crossref","unstructured":"Whitehouse F, Kruger DF, Fineman M, Shen L, Ruggles JA, Maggs DG, Weyer C, Kolterman OG: A randomized study and open-label extension evaluating the long-term efficacy of pramlintide as an adjunct to insulin therapy in type 1 diabetes. Diabetes Care\u200825: 724\u2013730, 2002","DOI":"10.2337\/diacare.25.4.724"},{"key":"2022031220325617200_R35","doi-asserted-by":"crossref","unstructured":"Riddle MC: Pramlintide: an agent for glycemic control plus weight control. Diabetes Technol Ther\u20084: 63\u201365, 2002","DOI":"10.1089\/15209150252924102"}],"container-title":["Diabetes Care"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/diabetesjournals.org\/care\/article-pdf\/26\/3\/784\/665362\/dc0303000784.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/diabetesjournals.org\/care\/article-pdf\/26\/3\/784\/665362\/dc0303000784.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,3,12]],"date-time":"2022-03-12T22:36:51Z","timestamp":1647124611000},"score":1,"resource":{"primary":{"URL":"https:\/\/diabetesjournals.org\/care\/article\/26\/3\/784\/29222\/Pramlintide-as-an-Adjunct-to-Insulin-Therapy"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2003,3,1]]},"references-count":35,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2003,3,1]]}},"URL":"https:\/\/doi.org\/10.2337\/diacare.26.3.784","relation":{},"ISSN":["0149-5992","1935-5548"],"issn-type":[{"value":"0149-5992","type":"print"},{"value":"1935-5548","type":"electronic"}],"subject":[],"published":{"date-parts":[[2003,3,1]]}}}