{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T09:21:50Z","timestamp":1792401710206,"version":"4.4.0"},"reference-count":29,"publisher":"American Diabetes Association","issue":"4","content-domain":{"domain":["diabetesjournals.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2002,4,1]]},"abstract":"<jats:p>OBJECTIVE\u2014To assess the effect of mealtime amylin replacement with pramlintide on long-term glycemic and weight control in patients with type 1 diabetes.<\/jats:p>\n                  <jats:p>RESEARCH DESIGN AND METHODS\u2014In a 52-week, double-blind, placebo-controlled, multicenter study, 480 patients with type 1 diabetes were randomized to receive preprandial injections of placebo or 30 \u03bcg pramlintide q.i.d., in addition to existing insulin regimens. At week 20, pramlintide-treated patients were re-randomized to 30 or 60 \u03bcg pramlintide q.i.d. if decreases from baseline in HbA1c were &amp;lt;1% at week 13. Of the 342 patients who completed the 52-week study, 236 individuals (\u223c70%) elected to participate in a 1-year open-label extension in which all patients received 30 or 60 \u03bcg pramlintide q.i.d..<\/jats:p>\n                  <jats:p>RESULTS\u2014Treatment with pramlintide led to a mean reduction in HbA1c of 0.67% from baseline to week 13 that was significantly (P &amp;lt; 0.0001) greater than the placebo reduction (0.16%), and a significant placebo-corrected treatment difference was sustained through week 52 (P = 0.0071). The greater HbA1c reduction was associated with an average weight loss, rather than weight gain, and was not accompanied by an increased overall event rate of severe hypoglycemia. In the open-label extension, mean HbA1c levels decreased rapidly in patients receiving pramlintide for the first time and remained at reduced levels in patients who continued pramlintide treatment. The most common adverse events reported by the pramlintide group were mild nausea and anorexia, which both occurred during the initial weeks of treatment and dissipated over time.<\/jats:p>\n                  <jats:p>CONCLUSIONS\u2014Mealtime pramlintide treatment as an adjunct to insulin improved long-term glycemic control without inducing weight gain or increasing the overall risk of severe hypoglycemia in patients with type 1 diabetes.<\/jats:p>","DOI":"10.2337\/diacare.25.4.724","type":"journal-article","created":{"date-parts":[[2007,3,5]],"date-time":"2007-03-05T17:51:27Z","timestamp":1173117087000},"page":"724-730","update-policy":"https:\/\/doi.org\/10.2337\/ada-journal-policies","source":"Crossref","is-referenced-by-count":233,"title":["A Randomized Study and Open-Label Extension Evaluating the Long-Term Efficacy of Pramlintide as an Adjunct to Insulin Therapy in Type 1 Diabetes"],"prefix":"10.2337","volume":"25","author":[{"given":"Fred","family":"Whitehouse","sequence":"first","affiliation":[{"name":"Henry Ford Hospital, Detroit, Michigan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Davida F.","family":"Kruger","sequence":"additional","affiliation":[{"name":"Henry Ford Hospital, Detroit, Michigan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Fineman","sequence":"additional","affiliation":[{"name":"Amylin Pharmaceuticals, San Diego, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Larry","family":"Shen","sequence":"additional","affiliation":[{"name":"Amylin Pharmaceuticals, San Diego, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James A.","family":"Ruggles","sequence":"additional","affiliation":[{"name":"Amylin Pharmaceuticals, San Diego, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David G.","family":"Maggs","sequence":"additional","affiliation":[{"name":"Amylin Pharmaceuticals, San Diego, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Weyer","sequence":"additional","affiliation":[{"name":"Amylin Pharmaceuticals, San Diego, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Orville G.","family":"Kolterman","sequence":"additional","affiliation":[{"name":"Amylin Pharmaceuticals, San Diego, California"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1167","reference":[{"key":"2022031214031016200_R1","doi-asserted-by":"crossref","unstructured":"Atkinson MA, Maclaren NK: The pathogenesis of insulin-dependent diabetes mellitus. 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