Adjunctive Therapy with the Amylin Analogue Pramlintide Leads to a Combined Improvement in Glycemic and Weight Control in Insulin-Treated Subjects with Type 2 Diabetes
Abstract
The objective of this study was to assess the effect of mealtime amylin replacement with pramlintide on long-term glycemic and weight control in subjects with type 2 diabetes. This 52-week, randomized, placebo-controlled, multicenter, double-blind, dose-ranging study in 538 insulin-treated subjects with type 2 diabetes compared the efficacy and safety of 30-, 75-, or 150-microg doses of pramlintide, a synthetic analogue of the beta-cell hormone amylin, to placebo when injected subcutaneously three times daily (TID) with major meals. Pramlintide therapy led to a mean reduction in HbA1c of 0.9% and 1.0% from baseline to week 13 in the 75- and 150-microg dose groups, which was significant compared to placebo (p = 0.0004 and p = 0.0002, respectively). In the 150-microg dose group, there was a mean reduction in HbA1c of 0.6% from baseline to week 52 (p = 0.0068 compared to placebo). The greater reduction in HbA1c with pramlintide was achieved without increases in insulin use or severe hypoglycemia, and was accompanied by a significant (p < 0.05) reduction in body weight in all dose groups compared to placebo. Three times the proportion of subjects in the 150-microg pramlintide group compared to the placebo group achieved a concomitant reduction in both HbA1c and body weight from baseline to week 52 (48% versus 16%). The most common adverse event reported with pramlintide treatment was nausea, which was mild to moderate and dissipated early in treatment. The results from this study…
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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).”
Cites
U.K. Prospective Diabetes Study Group (1995) · Diabetes · doi:10.2337/diab.44.11.1249 · Cited by 1,923 · see citing works
Association, A. D. (2001) · Diabetes Care · doi:10.2337/diacare.24.4.775 · Cited by 464 · see citing works
Hollander, P. A., Levy, P., Fineman, M. S., Maggs, D. G., Shen, L. Z., Strobel, S. A., Weyer, C., & Kolterman, O. G. (2003) · Diabetes Care · doi:10.2337/diacare.26.3.784 · Cited by 307 · see citing works
Self-citationCombination therapies with insulin in type 2 diabetes
Yki-Järvinen, H. (2001) · Diabetes Care · doi:10.2337/diacare.24.4.758 · Cited by 300 · see citing works
Whitehouse, F., Kruger, D. F., Fineman, M., Shen, L., Ruggles, J. A., Maggs, D. G., Weyer, C., & Kolterman, O. G. (2002) · Diabetes Care · doi:10.2337/diacare.25.4.724 · Cited by 264 · see citing works
Self-citationFujioka, K., Seaton, T. B., Rowe, E., Jelinek, C. A., Raskin, P., Lebovitz, H. E., Weinstein, S. P., & Group, T. S. C. S. (2000) · Diabetes, Obesity and Metabolism · doi:10.1046/j.1463-1326.2000.00081.x · Cited by 244 · see citing works
Henry, R. R., Gumbiner, B., Ditzler, T., Wallace, P., Lyon, R., & Glauber, H. S. (1993) · Diabetes Care · doi:10.2337/diacare.16.1.21 · Cited by 227 · see citing works
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9. Pharmacologic Approaches to Glycemic Treatment: <i>Standards of Medical Care in Diabetes—2022</i>
American Diabetes Association Professional Practice Committee (2022) · Diabetes Care · doi:10.2337/dc22-s009 · Cited by 1,555 · see citing works
9. Pharmacologic Approaches to Glycemic Treatment: <i>Standards of Care in Diabetes—2023</i>
ElSayed, N. A., Aleppo, G., Aroda, V. R., Bannuru, R. R., Brown, F. M., Bruemmer, D., Collins, B. S., Hilliard, M. E., Isaacs, D., Johnson, E. L., et al. (2023) · Diabetes Care · doi:10.2337/dc23-s009 · Cited by 851 · see citing works
Holt, R. I. G., DeVries, J. H., Hess-Fischl, A., Hirsch, I. B., Kirkman, M. S., Klupa, T., Ludwig, B., Nørgaard, K., Pettus, J., Renard, E., et al. (2021) · Diabetes Care · doi:10.2337/dci21-0043 · Cited by 699 · see citing works
Hollander, P. A., Levy, P., Fineman, M. S., Maggs, D. G., Shen, L. Z., Strobel, S. A., Weyer, C., & Kolterman, O. G. (2003) · Diabetes Care · doi:10.2337/diacare.26.3.784 · Cited by 307 · see citing works
Self-citationEffect of pramlintide on satiety and food intake in obese subjects and subjects with type 2 diabetes
Chapman, I., Parker, B., Doran, S., Feinle-Bisset, C., Wishart, J., Strobel, S., Wang, Y., Burns, C., Lush, C., Weyer, C., et al. (2005) · Diabetologia · doi:10.1007/s00125-005-1732-4 · Cited by 205 · see citing works
Self-citationAntidiabetic agents as a novel treatment for Alzheimer’s and Parkinson’s disease
Nowell, J., Blunt, E., Gupta, D., & Edison, P. (2023) · Ageing Research Reviews · doi:10.1016/j.arr.2023.101979 · Cited by 179 · see citing works
Aronne, L., Fujioka, K., Aroda, V., Chen, K., Halseth, A., Kesty, N. C., Burns, C., Lush, C. W., & Weyer, C. (2007) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2006-2003 · Cited by 178 · see citing works
Self-citationEfficacy and harms of the hypoglycemic agent pramlintide in diabetes mellitus
Lee, N. J., Norris, S. L., & Thakurta, S. (2010) · The Annals of Family Medicine · doi:10.1370/afm.1174 · Cited by 39 · see citing works
Pramlintide: Clinical Strategies for Success
Alrefai, H. A., Latif, K. A., Hieronymus, L. B., Weakley, C. R., & Moss, R. J. (2010) · Diabetes Spectrum · doi:10.2337/diaspect.23.2.124 · Cited by 16 · see citing works
- Authors
- Ratner, R. E., Want, L. L., Fineman, M. S., Velte, M. J., Ruggles, J. A., Gottlieb, A., Weyer, C., & Kolterman, O. G.
- Affiliations
- MedStar Health Research Institute (US)
- Amylin Pharmaceuticals Inc., San Diego, California
- Venue
- Diabetes Technology & Therapeutics
- Publisher
- SAGE Publications
- Published
- 2002-02
- Volume
- 4
- Issue
- 1
- Pages
- 51-61
- ISSN
- 1520-9156 (ISSN-L)
- 1557-8593
- OpenAlex
- W1982298257
- Cited by
- 156
- References
- 7
- Citations by year
- 2026: 2 · 2025: 1 · 2024: 5 · 2023: 4 · 2022: 4 · 2021: 5 · 2020: 3 · 2019: 1 · 2017: 1 · 2016: 5 · 2015: 3 · 2014: 5 · 2013: 3 · 2012: 4
- FWCI
- 5.77
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Diabetes Technology & Therapeutics (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Keywords
- pramlintide, amylin analogues, type 2 diabetes, insulin-treated patients, adjunctive therapy, glycemic control, HbA1c, weight loss, nausea, hypoglycemia, dose-ranging
- MeSH terms
- Adult, Aged, Amyloid, Blood Glucose, Body Weight, Diabetes Mellitus, Type 2, Dose-Response Relationship, Drug, Double-Blind Method, Drug Therapy, Combination, Female, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Insulin, Male, Middle Aged, Placebos, Time Factors, United States, Treatment Outcome, Racial Groups, Islet Amyloid Polypeptide
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