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Pramlintide as an Adjunct to Insulin Therapy Improves Long-Term Glycemic and Weight Control in Patients With Type 2 Diabetes
Open accessAbstract
OBJECTIVE—Mealtime 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. RESEARCH DESIGN AND METHODS—In a 52-week, double-blind, placebo-controlled, parallel-group, multicenter study, 656 patients with type 2 diabetes (age 57 ± 10 years, diabetes duration 12 ± 7 years, BMI 34.0 ± 7.0 kg/m2, HbA1c 9.1 ± 1.2%, mean ± 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 μg TID, 90 μg BID, or 120 μg BID). RESULTS—Treatment with pramlintide 120 μg BID led to a sustained reduction from baseline in HbA1c (−0.68 and −0.62% at weeks 26 and 52, respectively), which was significantly greater than that seen with placebo (P < 0.05). The proportion of patients achieving an HbA1c <8% was approximately twofold greater with pramlintide (120 μg BID) than with placebo (46 vs. 28%, P < 0.05). The glycemic improvement with pramlintide 120 μg BID was accompanied by a mean weight loss (−1.4 kg vs. +0.7 kg with placebo at week 52, P < 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. CONCLUSIONS—Mealtime amylin replacement with pramlintide 120 μg BID, as an adjunct to insulin therapy, improves long-term glycemic and weight control in patients with type 2 diabetes.
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“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).”
From The management of type 1 diabetes in adults. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) (2021) · cites this paper as [253]
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“Somewhat greater weight loss was noted in type 2 diabetic patients treated with pramlintide.212”
From Obesity‐Related Hypertension: Pathogenesis, Cardiovascular Risk, and Treatment: A Position Paper of The Obesity Society and the American Society of Hypertension (2013) · cites this paper as [212]
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Insulin therapy for type 2 diabetes
Sasali, A., & Leahy, J. L. (2003) · Current Diabetes Reports · doi:10.1007/s11892-003-0081-2 · Cited by 13
Primer on Pramlintide, an Amylin Analog
Traina, A. N., & Kane, M. P. (2011) · The Science of Diabetes Self-Management and Care · doi:10.1177/0145721711403011 · Cited by 12
“The rate of hypoglycemia in pramlintide-treated patients in clinical trials was 2- to 4-fold greater than the placebo group’s rate during the first 4 weeks of therapy.(12,13) The risk of hypoglycemia, especially in patients with type 1 diabetes, resulted in a boxed warning for hypoglycemia being placed in the Symlin p…”
BackgroundPramlintide for post‐bariatric hypoglycaemia
Sheehan, A. L., Goldfine, A. B., Bajwa, M., Wolfs, D., Kozuka, C., Piper, J., Fowler, K. M., & Patti, M. (2022) · Diabetes Obesity and Metabolism · doi:10.1111/dom.14665 · Cited by 13
“Prior studies showed that pramlintide significantly reduced the frequency and magnitude of postprandial glycaemic fluctuations in type 1 diabetes,(37,38) attributed to reduced food intake (increased satiation), increased satiety, delayed gastric emptying, and decreased early postprandial incretin and glucagon secretio…”
BackgroundTu, L., Noor, H., Cao, P., & Raleigh, D. P. (2014) · ACS Chemical Biology · doi:10.1021/cb500162w · Cited by 12
Be positive: optimizing pramlintide from microcanonical analysis of amylin isoforms
Frigori, R. B. (2017) · Physical Chemistry Chemical Physics · doi:10.1039/c7cp04074a · Cited by 12
Hormone-based therapies in the regulation of fuel metabolism and body weight
Kesty, N. C., Roth, J. D., & Maggs, D. G. (2008) · Expert Opinion on Biological Therapy · doi:10.1517/14712598.8.11.1733 · Cited by 12
“5%) with reductions in body weight [25-28] .”
BackgroundSelf-citationNew Therapeutic Agents for Diabetes Mellitus: Implications for Anesthetic Management
Chen, D., Lee, S. L., & Peterfreund, R. A. (2009) · Anesthesia & Analgesia · doi:10.1213/ane.0b013e31819dcc51 · Cited by 12
Food intake and meal pattern in IAPP knockout mice with and without infusion of exogenous IAPP
Olsson, M., Herrington, M. K., Reidelberger, R. D., Permert, J., Gebré‐Medhin, S., & Arnelo, U. (2012) · Scandinavian Journal of Gastroenterology · doi:10.3109/00365521.2011.638392 · Cited by 12
“The IAPP analog pramlintide has been shown to reduce caloric intake and body weight in obese and normal weight people [15–17] and to aid in the management of FI and body weight in patients with type I and type II diabetes mellitus [18,19].”
BackgroundOptimizing Diabetes Treatment Using an Amylin Analogue
Edelman, S. V. (2008) · The Science of Diabetes Self-Management and Care · doi:10.1177/0145721707313939 · Cited by 12
Managing Highly Insulin-Resistant Diabetes Mellitus: Weight Loss Approaches and Medical Management
Brown, A., Desai, M., Taneja, D., & Tannock, L. R. (2010) · Postgraduate Medicine · doi:10.3810/pgm.2010.01.2110 · Cited by 12
“4-kg early reduction in weight.(57,58) Despite these benefi ts of early weight loss and improved glycemic control, there is a tendency to regain weight after 15 months of therapy.”
BackgroundRecent and Emerging Therapeutic Medications in Type 2 Diabetes Mellitus
Lo, M. C., & Lansang, M. C. (2010) · American Journal of Therapeutics · doi:10.1097/mjt.0b013e3181ec9eb2 · Cited by 12
Phillips, L. K., & Horowitz, M. (2006) · Current Opinion in Endocrinology & Diabetes · doi:10.1097/01.med.0000216969.59375.39 · Cited by 12
Type 2 Diabetes Mellitus: An Evidence-Based Approach to Practical Management
Lingvay, I., Rhee, C., & Raskin, P. (2008) · Humana Press eBooks · doi:10.1007/978-1-60327-043-4_10 · Cited by 12
New and Emerging Strategies for Reducing Cardiometabolic Risk Factors
Rodgers, P. T., & Fuke, D. C. (2006) · Pharmacotherapy The Journal of Human Pharmacology and Drug Therapy · doi:10.1592/phco.26.5part2.13s · Cited by 12
Alternative therapeutic strategies in diabetes management
Annicchiarico, A., Barile, B., Buccoliero, C., Nicchia, G. P., & Brunetti, G. (2024) · World Journal of Diabetes · doi:10.4239/wjd.v15.i6.1142 · Cited by 12
Amylin and pramlintide modulate γ-secretase level and APP processing in lipid rafts
Mousa, Y. M., Abdallah, I. M., Hwang, M., Martin, D. R., & Kaddoumi, A. (2020) · Scientific Reports · doi:10.1038/s41598-020-60664-5 · Cited by 11
Amylin reduces plasma glucagon concentration in cats
Furrer, D., Kaufmann, K., Reusch, C. E., & Lutz, T. A. (2009) · The Veterinary Journal · doi:10.1016/j.tvjl.2009.02.011 · Cited by 11
Gut-Brain Endocrine Axes in Weight Regulation and Obesity Pharmacotherapy
Merlino, D. J., Blomain, E. S., Aing, A., & Waldman, S. A. (2014) · Journal of Clinical Medicine · doi:10.3390/jcm3030763 · Cited by 13
“Pramlintide’s side effect profile was favorable, with adverse reactions limited to mild to moderate nausea and headache along with pain at the injection site [162–168].”
What's new in ... clinical pharmacology and therapeutics.
Chawla, P. S., & Kochar, M. S. (1996) · PubMed · Cited by 11
Metadata
- Authors
- Hollander, P. A., Levy, P., Fineman, M. S., Maggs, D. G., Shen, L. Z., Strobel, S. A., Weyer, C., & Kolterman, O. G.
- Affiliations
- Baylor University Medical Center (US)
- Phoenix Endocrinology Clinic, Phoenix, Arizona
- Amylin Pharmaceuticals, Inc., San Diego, California
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2003-03-01
- Volume
- 26
- Issue
- 3
- Pages
- 784-790
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- OpenAlex
- W2045554373
- Cited by
- 307
- References
- 32
- Citations by year
- 2026: 8 · 2025: 9 · 2024: 10 · 2023: 6 · 2022: 8 · 2021: 12 · 2020: 9 · 2019: 4 · 2018: 5 · 2017: 8 · 2016: 13 · 2015: 8 · 2014: 10 · 2013: 11 · 2012: 14
- FWCI
- 10.64
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Diabetes Care (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 (medical) › Pharmacology and Obesity Treatment
- Keywords
- pramlintide, amylin analogues, type 2 diabetes, insulin therapy, glycemic control, HbA1c, weight loss, hypoglycemia, nausea, long-term efficacy and safety
- MeSH terms
- Aged, Amyloid, Blood Glucose, Body Weight, Diabetes Mellitus, Type 2, Drug Therapy, Combination, Female, Glycated Hemoglobin, Humans, Hypoglycemia, Hypoglycemic Agents, Insulin, Male, Middle Aged, Incidence, Treatment Outcome, Islet Amyloid Polypeptide
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