Pramlintide Improved Glycemic Control and Reduced Weight in Patients With Type 2 Diabetes Using Basal Insulin
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OBJECTIVE— To assess the efficacy and safety of pramlintide in patients with type 2 diabetes suboptimally controlled with basal insulin. RESEARCH DESIGN AND METHODS— In a 16-week, double-blind, placebo-controlled study, 212 patients using insulin glargine with or without oral antidiabetes agents (OAs) were randomized to addition of pramlintide (60 or 120 μg b.i.d./t.i.d.) or placebo. Insulin glargine was adjusted to target a fasting plasma glucose concentration of 70–100 mg/dl. One coprimary end point was the change in A1C at week 16. The other coprimary end point was a composite measure of overall diabetes control comprising A1C ≤7.0% or reduction ≥0.5%, mean daily postprandial glucose (PPG) increments ≤40 mg/dl, no increase in body weight, and no severe hypoglycemia. Patients meeting all four conditions at week 16 achieved this end point. RESULTS—More pramlintide- than placebo-treated patients achieved the composite end point (25 vs. 7%; P < 0.001). Reductions (means ± SE) in A1C (−0.70 ± 0.11% vs. −0.36 ± 0.08%; P < 0.05) and PPG increments (−24.4 ± 3.6 mg/dl vs. −0.4 ± 3.0 mg/dl; P < 0.0001) were greater in pramlintide- versus placebo-treated patients, respectively. Glycemic improvements were accompanied by progressive weight loss with pramlintide and weight gain with placebo (−1.6 ± 0.3 kg vs. +0.7 ± 0.3 kg; P < 0.0001). No treatment-related severe hypoglycemia occurred. CONCLUSIONS— Pramlintide improved multiple glycemic parameters and reduced weight with no increase in hypoglycemia in patients with type 2 diabetes who were not achieving glycemic targets with basal insulin with or without OAs.
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In clinical studies, pramlintide decreased A1C by 0.5-0.7 percentage points.
“In clinical studies, A1C has been decreased by 0.5–0.7 percentage points (82).”
From Medical Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy (2009) · cites this paper as [82]
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- Authors
- Riddle, M., Frias, J., Zhang, B., Maier, H., Brown, C., Lutz, K., & Kolterman, O.
- Affiliations
- Oregon Health & Science University (US)
- Amylin Pharmaceuticals, San Diego, California
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2007-11-01
- Volume
- 30
- Issue
- 11
- Pages
- 2794-2799
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- OpenAlex
- W2114626270
- Cited by
- 116
- References
- 23
- Citations by year
- 2026: 2 · 2025: 2 · 2024: 2 · 2023: 4 · 2022: 7 · 2021: 6 · 2020: 1 · 2019: 2 · 2018: 5 · 2017: 7 · 2016: 5 · 2015: 10 · 2014: 2 · 2013: 8 · 2012: 6
- FWCI
- 9.74
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Diabetes Care (publishedVersion)
- PubMed (publishedVersion)
- Funders
- American Diabetes Association
- Eli Lilly and Company
- Pfizer
- Amylin Pharmaceuticals
- GlaxoSmithKline
- Sanofi
- European Foundation for the Study of Diabetes
- 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, type 2 diabetes, basal insulin, insulin glargine, glycemic control, weight loss, postprandial blood glucose, HbA1c, oral antidiabetic drugs, hypoglycemia, incretin-based therapy
- MeSH terms
- Insulin Glargine, Administration, Oral, Adult, Aged, Amyloid, Blood Glucose, Diabetes Mellitus, Type 2, Drug Therapy, Combination, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Insulin, Middle Aged, Placebos, Blood Glucose Self-Monitoring, Weight Loss, Treatment Outcome, Insulin, Long-Acting, Islet Amyloid Polypeptide
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