The lancet. Diabetes & endocrinology
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Lancet Diabetes Endocrinol · Apr 2014
Randomized Controlled Trial Multicenter Study Comparative StudyOnce-weekly albiglutide versus once-daily liraglutide in patients with type 2 diabetes inadequately controlled on oral drugs (HARMONY 7): a randomised, open-label, multicentre, non-inferiority phase 3 study.
As new members of a drug class are developed, head-to-head trials are an important strategy to guide personalised treatment decisions. We assessed two glucagon-like peptide-1 receptor agonists, once-weekly albiglutide and once-daily liraglutide, in patients with type 2 diabetes inadequately controlled on oral antidiabetic drugs. ⋯ GlaxoSmithKline.
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Lancet Diabetes Endocrinol · Mar 2014
Randomized Controlled TrialDirect iodine supplementation of infants versus supplementation of their breastfeeding mothers: a double-blind, randomised, placebo-controlled trial.
Iodine deficiency in infants can damage the developing brain and increase mortality. Present recommendations state that oral iodised oil should be given to breastfeeding mothers to correct iodine deficiency in infancy when iodised salt is not available, and that direct supplementation should be given to infants who are not being breastfed or receiving iodine-fortified complimentary foods. However, there is little evidence for these recommendations. We aimed to assess the safety and efficacy of direct versus indirect supplementation of the infant. ⋯ ETH Zurich, Switzerland; the Medicor Foundation, Vaduz, Lichtenstein.
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Lancet Diabetes Endocrinol · Feb 2014
Randomized Controlled TrialMetformin for non-diabetic patients with coronary heart disease (the CAMERA study): a randomised controlled trial.
Metformin reduces cardiovascular risk in patients with type 2 diabetes seemingly independent of lowering blood glucose concentration. We assessed the cardiovascular effects of metformin in individuals without type 2 diabetes. ⋯ Chief Scientist Office (Scotland).
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Lancet Diabetes Endocrinol · Dec 2013
Randomized Controlled Trial Multicenter StudyAntithymocyte globulin treatment for patients with recent-onset type 1 diabetes: 12-month results of a randomised, placebo-controlled, phase 2 trial.
Type 1 diabetes results from T-cell-mediated destruction of β cells. Findings from preclinical studies and pilot clinical trials suggest that antithymocyte globulin (ATG) might be effective for reducing this autoimmune response. We assessed the safety and efficacy of rabbit ATG in preserving islet function in participants with recent-onset type 1 diabetes, and report here our 12-month results. ⋯ Our findings suggest that a brief course of ATG does not result in preservation of β-cell function 12 months later in patients with new-onset type 1 diabetes. Generalised T-cell depletion in the absence of specific depletion of effector memory T cells and preservation of regulatory T cells seems to be an ineffective treatment for type 1 diabetes.
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Lancet Diabetes Endocrinol · Dec 2013
Randomized Controlled Trial Multicenter StudyTargeting of memory T cells with alefacept in new-onset type 1 diabetes (T1DAL study): 12 month results of a randomised, double-blind, placebo-controlled phase 2 trial.
Type 1 diabetes results from autoimmune targeting of the pancreatic β cells, likely mediated by effector memory T (Tem) cells. CD2, a T cell surface protein highly expressed on Tem cells, is targeted by the fusion protein alefacept, depleting Tem cells and central memory T (Tcm) cells. We postulated that alefacept would arrest autoimmunity and preserve residual β cells in patients newly diagnosed with type 1 diabetes. ⋯ Although the primary outcome was not met, at 12 months, alefacept preserved the 4 h C-peptide AUC, lowered insulin use, and reduced hypoglycaemic events, suggesting efficacy. Safety and tolerability were similar in the alefacept and placebo groups. Alefacept could be useful to preserve β-cell function in patients with new-onset type 1 diabetes.