Amylin replacement with pramlintide as an adjunct to insulin therapy improves long‐term glycaemic and weight control in Type 1 diabetes mellitus: a 1‐year, randomized controlled trial
Abstract
Aims The autoimmune-mediated destruction of pancreatic beta-cells in Type 1 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-term efficacy and safety of adjunctive therapy with pramlintide, a synthetic human amylin analogue, in patients with Type 1 diabetes. Methods In a double-blind, placebo-controlled, parallel-group, multicentre study, 651 patients with Type 1 diabetes (age 41 +/- 13 years, HbA(1c) 8.9 +/- 1.0%, mean +/- sd) were randomized to mealtime injections of placebo or varying doses of pramlintide, in addition to their insulin therapy, for 52 weeks. Results Addition of pramlintide [60 microg three times daily (TID) or four times daily (QID)] to insulin led to significant reductions in HbA(1c) from baseline to Week 52 of 0.29% (P Conclusions These results show that mealtime amylin replacement with pramlintide, as an adjunct to insulin therapy, improves long-term glycaemic and weight control in patients with Type 1 diabetes.
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Clinical trials have shown pramlintide reduces HbA1c by 0.3-0.4% (3-4 mmol/mol) and causes modest (1 kg) weight loss.
“Clinical trials have shown a reduction in HbA 1c (0.3-0.4% [3-4 mmol/ mol]) and modest (1 kg) weight loss (251-254).”
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- Authors
- Ratner, R. E., Dickey, R., Fineman, M., Maggs, D. G., Shen, L., Strobel, S. A., Weyer, C., & Kolterman, O. G.
- Corresponding author
- Kolterman, O. G.
- Venue
- Diabetic Medicine
- Publisher
- Wiley
- Published
- 2004-10-20
- Volume
- 21
- Issue
- 11
- Pages
- 1204-1212
- ISSN
- 0742-3071 (ISSN-L)
- 1464-5491
- OpenAlex
- W2065786925
- Cited by
- 307
- References
- 6
- Citations by year
- 2026: 9 · 2025: 13 · 2024: 13 · 2023: 13 · 2022: 11 · 2021: 20 · 2020: 17 · 2019: 13 · 2018: 13 · 2017: 10 · 2016: 12 · 2015: 11 · 2014: 5 · 2013: 13 · 2012: 13
- FWCI
- 10.75
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Diabetic Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Keywords
- pramlintide, amylin analogues, type 1 diabetes, insulin therapy, adjunctive therapy, glycemic control, HbA1c, weight management, mealtime insulin, nausea
- MeSH terms
- Adult, Aged, Amyloid, Blood Glucose, Body Weight, Diabetes Mellitus, Type 1, Double-Blind Method, Drug Therapy, Combination, Female, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Insulin, Male, Middle Aged, Islet Amyloid Polypeptide
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