{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T00:40:33Z","timestamp":1789605633637,"version":"build-2803163510"},"reference-count":34,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2004,10,20]],"date-time":"2004-10-20T00:00:00Z","timestamp":1098230400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetic Medicine"],"published-print":{"date-parts":[[2004,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p><jats:bold>Aims\u2003<\/jats:bold> The autoimmune\u2010mediated destruction of pancreatic \u03b2\u2010cells in Type\u00a01 diabetes mellitus renders patients deficient in two glucoregulatory peptide hormones, insulin and amylin. With insulin replacement alone, most patients do not achieve glycaemic goals. We aimed to determine the long\u2010term efficacy and safety of adjunctive therapy with pramlintide, a synthetic human amylin analogue, in patients with Type\u00a01 diabetes.<\/jats:p><jats:p><jats:bold>Methods\u2003<\/jats:bold> In a double\u2010blind, placebo\u2010controlled, parallel\u2010group, multicentre study, 651 patients with Type\u00a01 diabetes (age 41\u00a0\u00b1\u00a013\u00a0years, HbA<jats:sub>1c<\/jats:sub> 8.9\u00a0\u00b1\u00a01.0%, mean\u00a0\u00b1\u00a0<jats:sc>sd<\/jats:sc>) were randomized to mealtime injections of placebo or varying doses of pramlintide, in addition to their insulin therapy, for 52\u00a0weeks.<\/jats:p><jats:p><jats:bold>Results\u2003<\/jats:bold> Addition of pramlintide [60\u00a0\u00b5g three times daily (TID) or four times daily (QID)] to insulin led to significant reductions in HbA<jats:sub>1c<\/jats:sub> from baseline to Week\u00a052 of 0.29% (<jats:italic>P\u00a0&lt;<\/jats:italic>\u00a00.011) and 0.34% (<jats:italic>P\u00a0&lt;<\/jats:italic>\u00a00.001), respectively, compared with a 0.04% reduction in placebo group. Three times the proportion of pramlintide\u2010 than placebo\u2010treated patients achieved an HbA<jats:sub>1c<\/jats:sub> of &lt;\u00a07%. The greater reduction in HbA<jats:sub>1c<\/jats:sub> with pramlintide was achieved without an increase in concomitant insulin use and was accompanied by a significant reduction in body weight from baseline to Week\u00a052 of 0.4\u00a0kg in the 60\u00a0\u00b5g TID (<jats:italic>P\u00a0&lt;<\/jats:italic>\u00a00.027) or QID (<jats:italic>P\u00a0&lt;<\/jats:italic>\u00a00.040) pramlintide treatment groups, compared with a 0.8\u2010kg gain in body weight in the placebo group. The most common adverse event in pramlintide\u2010treated patients was transient, mild\u2010to\u2010moderate nausea.<\/jats:p><jats:p><jats:bold>Conclusions\u2003<\/jats:bold> These results show that mealtime amylin replacement with pramlintide, as an adjunct to insulin therapy, improves long\u2010term glycaemic and weight control in patients with Type\u00a01 diabetes.<\/jats:p>","DOI":"10.1111\/j.1464-5491.2004.01319.x","type":"journal-article","created":{"date-parts":[[2004,10,20]],"date-time":"2004-10-20T08:53:22Z","timestamp":1098262402000},"page":"1204-1212","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":266,"title":["Amylin replacement with pramlintide as an adjunct to insulin therapy improves long\u2010term glycaemic and weight control in Type\u00a01 diabetes mellitus: a 1\u2010year, randomized controlled trial"],"prefix":"10.1111","volume":"21","author":[{"given":"R. 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