Semaglutide added to basal insulin in type 2 diabetes (SUSTAIN 5): a randomised, controlled trial.

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Semaglutide added to basal insulin in type 2 diabetes (SUSTAIN 5): a randomised, controlled trial.

J Clin Endocrinol Metab. 2018 Apr 23;:

Authors: Rodbard HW, Lingvay I, Reed J, de la Rosa R, Rose L, Sugimoto D, Araki E, Chu PL, Wijayasinghe N, Norwood P

Abstract
Context: Combination therapy with insulin and glucagon-like peptide-1 receptor agonists (GLP-1RAs) is increasingly important for treating type 2 diabetes (T2D). This trial assesses the efficacy and safety of semaglutide, a GLP-1RA, as an add-on to basal insulin.
Objective: To demonstrate the superiority of semaglutide versus placebo on glycaemic control as add-on to basal insulin in patients with T2D.
Design: Phase 3a, double blind, placebo-controlled, 30-week trial.
Setting: 90 sites in five countries.
Patients: 397 patients with uncontrolled T2D receiving stable therapy with basal insulin ± metformin.
Interventions: Subcutaneous semaglutide 0.5 or 1.0 mg once weekly, or volume-matched placebo.
Main Outcome Measures: Primary endpoint was change in glycated haemoglobin (HbA1c) from baseline to Week 30. Confirmatory secondary endpoint was change in body weight from baseline to Week 30.
Results: At Week 30, mean HbA1c reductions (mean baseline value 8.4% [67.9 mmol/mol]) with semaglutide 0.5 and 1.0 mg were 1.4% (15.8 mmol/mol) and 1.8% (20.2 mmol/mol), versus 0.1% (1.0 mmol/mol) with placebo (estimated treatment difference [ETD] [95% confidence interval (CI)] versus placebo -1.35 (14.8 mmol/mol), [-1.61; -1.10] and -1.75% (19.2 mmol/mol), [-2.01; -1.50]; both p<0.0001). Severe or blood glucose-confirmed hypoglycaemic episodes were reported in 11 patients (17 events) and 14 (25 events) patients with semaglutide 0.5 mg and 1.0 mg, respectively, versus 7 patients (13 events) with placebo (estimated rate ratios versus placebo [95% CI], 2.08 [0.67; 6.51] and 2.41 [0.84; 6.96] for 0.5 and 1.0 mg; both p=nonsignificant). Mean body weight decreased with semaglutide 0.5 and 1.0 mg, versus placebo from baseline to end-of-treatment: 3.7, 6.4 and 1.4 kg (ETD [95% CI], -2.31 [-3.33; -1.29], and -5.06 [-6.08; -4.04] kg; both p<0.0001). Premature treatment discontinuation due to adverse events were higher for semaglutide 0.5 and 1.0 mg versus placebo (4.5, 6.1 and 0.8%), mainly due to gastrointestinal disorders.
Conclusions: Semaglutide, added to basal insulin, significantly reduced HbA1c and body weight in patients with uncontrolled T2D versus placebo.

PMID: 29688502 [PubMed - as supplied by publisher]

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