Pramlintide — clinical evidence
Assessed outcomes with certainty ratings, contributing trials and the reasoning for each rating.
§3Clinical evidence
§3.1Adjunctive therapy in type 1 diabetes
Anchor outcome. Change in HbA1c.
Effect as recorded. HbA1c reduction of approximately 0.3 % with weight reduction of 1.4 kg and reduced insulin requirement; estimated HbA1c difference −0.3 % (95 % CI −0.4 to −0.2).[1,2]
Certainty. Moderate certainty The only amylin analogue with an approved indication as an insulin adjunct. Modest glycaemic effect with a meaningful severe-hypoglycaemia signal at initiation.
Contributing trials. PRAM-T1D-PIVOTAL. Full structured abstracts are published for each.
Full evidence extract for adjunctive therapy in type 1 diabetes · Indication assessment
§3.2Type 2 diabetes mellitus
Anchor outcome. Change in HbA1c (%, mmol/mol).
Effect as recorded. HbA1c −0.62 % versus −0.18 % with placebo at 52 weeks, with weight −1.4 kg; estimated difference −0.44 % (95 % CI −0.63 to −0.25).[2,3]
Certainty. Moderate certainty Insulin-treated type 2 diabetes.
Contributing trials. PRAM-T2D-1YR. Full structured abstracts are published for each.
Full evidence extract for type 2 diabetes mellitus · Indication assessment
§3.3Obesity and overweight in adults
Anchor outcome. Percentage change in body weight from baseline.
Effect as recorded. −3.7 kg at 16 weeks versus placebo in a non-diabetic obesity study; modest.[3,4]
Certainty. Low certainty No obesity indication was pursued; the compound requires three-times-daily injection.
Contributing trials. PRAM-OBESITY-PH2. Full structured abstracts are published for each.
Full evidence extract for obesity and overweight in adults · Indication assessment
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Hollander PA, Levy P, Fineman MS, Maggs DG, Shen LZ, Strobel SA, Weyer C, Kolterman OG. Pramlintide as an adjunct to insulin therapy improves long-term glycemic and weight control in patients with type 2 diabetes: a 1-year randomized controlled trial. Diabetes Care 2003;26(3):784–790. doi:10.2337/diacare.26.3.784 · PMID 12610038
- Lau DCW, Erichsen L, Francisco AM, Satylganova A, le Roux CW, McGowan B, Pedersen SD, Pietiläinen KH, Rubino DM, Batterham RL. Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial. The Lancet 2021;398(10317):2160–2172. doi:10.1016/S0140-6736(21)01751-7 · PMID 34798060
- D’Hondt M, Bracke N, Taevernier L, Gevaert B, Verbeke F, Wynendaele E, De Spiegeleer B. Related impurities in peptide medicines. Journal of Pharmaceutical and Biomedical Analysis 2014;101:2–30. doi:10.1016/j.jpba.2014.06.012 · PMID 25044089
- Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. Stability of protein pharmaceuticals: an update. Pharmaceutical Research 2010;27(4):544–575. doi:10.1007/s11095-009-0045-6 · PMID 20143256
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