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Pramlintide as an Adjunct to Insulin Therapy Improves Long-Term Glycemic and Weight Control in Patients With Type 2 Diabetes
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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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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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