Effect of exenatide QW or placebo,both added to titrated insulin glargine,in uncontrolled type 2 diabetes: The DURATION‐7 randomized study |
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| Authors: | Cristian Guja MD Juan P. Frías MD Aniko Somogyi MD Serge Jabbour MD Hui Wang PhD Elise Hardy MD Julio Rosenstock MD |
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| Affiliation: | 1. Department of Diabetes, Nutrition and Metabolic Diseases, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania;2. National Institute of Diabetes, Nutrition and Metabolic Diseases, “NC Paulescu”, Bucharest, Romania;3. National Research Institute, Los Angeles, California;4. 2nd Department of Internal Medicine, Semmelweis University, Budapest, Hungary;5. Division of Endocrinology, Diabetes & Metabolic Diseases, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania;6. AstraZeneca, Gaithersburg, Maryland;7. Dallas Diabetes Research Center at Medical City, Dallas, Texas |
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| Abstract: | Aims To compare the efficacy and safety of adding the glucagon‐like peptide‐1 receptor agonist exenatide once weekly (QW) 2 mg or placebo among patients with type 2 diabetes who were inadequately controlled despite titrated insulin glargine (IG) ± metformin. Methods This multicentre, double‐blind study ( ClinicalTrials.gov identifier: NCT02229383) randomized (1:1) patients with persistent hyperglycaemia after an 8‐week titration phase (glycated haemoglobin [HbA1c] 7.0%‐10.5% [53‐91 mmol/mol]) to exenatide QW or placebo. The primary endpoint was HbA1c change from baseline to week 28. Secondary endpoints included body weight, 2‐hour postprandial glucose, and mean daily IG dose. Results Of 464 randomized patients (mean: age, 58 years; HbA1c, 8.5% [69 mmol/mol]; diabetes duration, 11.3 years), 91% completed 28 weeks. Exenatide QW + IG vs placebo + IG significantly reduced HbA1c (least‐squares mean difference, ?0.73% [?8.0 mmol/mol]; 95% confidence interval, ?0.93%, ?0.53% [?10.2, ?5.8 mmol/mol]; P < .001; final HbA1c, 7.55% [59 mmol/mol] and 8.24% [67 mmol/mol], respectively); body weight (?1.50 kg; ?2.17, ?0.84; P < .001); and 2‐hour postprandial glucose (?1.52 mmol/L [?27.5 mg/dL]; ?2.15, ?0.90 [?38.7, ?16.2]; P < .001). Significantly more exenatide QW + IG‐treated patients vs placebo + IG‐treated patients reached HbA1c <7.0% (<53 mmol/mol) (32.5% vs 7.4%; P < .001); daily IG dose increased by 2 and 4 units, respectively. Gastrointestinal and injection‐site adverse events were more frequent with exenatide QW + IG (15.1% and 7.8%, respectively) than with placebo + IG (10.8% and 3.0%, respectively); hypoglycaemia incidence was similar between the exenatide QW + IG (29.7%) and placebo + IG (29.0%) groups, with no major hypoglycaemic events. Conclusions Among patients with inadequate glycaemic control, exenatide QW significantly improved glucose control and decreased body weight, without increased hypoglycaemia or unexpected safety findings. |
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| Keywords: | exenatide once weekly glucagon‐like peptide‐1 receptor agonist insulin glargine type 2 diabetes |
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