A 24-week study to evaluate the efficacy and safety of once-weekly dulaglutide added on to glimepiride in type 2 diabetes (AWARD-8)

Diabetes, Obesity & Metabolism
Kathleen M DunganK E Robertson

Abstract

To evaluate the safety and efficacy of once-weekly dulaglutide 1.5 mg, a long-acting glucagon-like peptide-1 receptor agonist, compared with placebo in patients with type 2 diabetes (T2D) on glimepiride monotherapy. This phase III, randomized (4 : 1; dulaglutide:placebo), double-blind, placebo-controlled, 24-week study compared the safety and efficacy of once-weekly dulaglutide 1.5 mg with placebo in sulphonylurea-treated (≥half-maximal dose, stable ≥3 months) patients (N = 300) with T2D and inadequate glycaemic control [glycated haemoglobin (HbA1c) ≥7.5 and ≤9.5% (≥58 mmol/mol and ≤80 mmol/mol)]. Analysis was carried out according to intention-to-treat. At baseline, the mean participant age was 58 years; mean HbA1c was 8.4% (68 mmol/mol) and mean weight was 85.5 kg. Dulaglutide 1.5 mg was superior to placebo at 24 weeks for HbA1c reduction from baseline with a between-group HbA1c difference of -1.3% [95% confidence interval (CI) -1.6, -1.0] or -14 mmol/mol (95% CI -17, -11); p < 0.001. A greater proportion of participants in the dulaglutide group reached an HbA1c level of <7.0% (53 mmol/mol) compared with placebo (55.3% vs 18.9%; p < 0.001). Dulaglutide significantly decreased fasting serum glucose from baseline compared with ...Continue Reading

References

Jun 26, 2003·JAMA : the Journal of the American Medical Association·Holly J KramerChi-Yuan Hsu
Oct 27, 2004·Diabetes Care·John B BuseUNKNOWN Exenatide-113 Clinical Study Group
May 23, 2009·Pharmacy World & Science : PWS·Juraporn PongwecharakNantida Pawangkapin
May 27, 2010·Diabetes/metabolism Research and Reviews·Wolfgang GlaesnerTom Bumol
Feb 5, 2011·Postgraduate Medicine·Serge Jabbour, Barry Ziring
Mar 1, 2012·The Journal of Clinical Endocrinology and Metabolism·Timothy M E DavisWendy A Davis
Apr 17, 2013·The Journal of Clinical Endocrinology and Metabolism·Elizabeth R SeaquistUNKNOWN Endocrine Society

❮ Previous
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Citations

Aug 5, 2016·Postgraduate Medicine·John E AndersonLuis-Emilio Garcia-Perez
Mar 10, 2017·Expert Opinion on Biological Therapy·André J Scheen
Jun 1, 2018·The Journal of Endocrinology·S J BrandtT D Müller
Aug 30, 2018·Journal of Managed Care & Specialty Pharmacy·Yehuda HandelsmanDoron Schneider
Aug 30, 2018·Journal of Managed Care & Specialty Pharmacy·Michael HeileMichael Shannon
Aug 30, 2018·Diabetes/metabolism Research and Reviews·Raffaella GentilellaAgostino Consoli
May 6, 2019·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Raffaella GentilellaGiorgio Sesti
Oct 13, 2019·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Hiren PatelManige Konig
Oct 28, 2019·Diabetes, Obesity & Metabolism·Louis S MatzaLuis-Emilio García-Pérez
Apr 18, 2020·The Journal of Clinical Endocrinology and Metabolism·Mario Luca MorieriGian Paolo Fadini
Jan 3, 2020·Current Pharmaceutical Biotechnology·Lin FanKaizong Huang
Sep 11, 2020·Journal of Clinical Pharmacy and Therapeutics·Dhiren Patel
Sep 11, 2020·Journal of Clinical Pharmacy and Therapeutics·Jennifer Trujillo
Aug 3, 2020·JAAPA : Official Journal of the American Academy of Physician Assistants·Ji Hyun Chun, Amy Butts
Jun 30, 2018·Pharmacy : Journal of Pharmacy, Education and Practice·Sivanandy PalanisamyYap Nee Chen
Feb 1, 2020·Drugs·Lesley J Scott
Aug 7, 2020·JAAPA : Official Journal of the American Academy of Physician Assistants·Ji Hyun Chun, Amy Butts
Jun 27, 2019·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Jee Hee YooWoo Je Lee
Jun 23, 2019·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Yan LiQiu He Ji
Sep 26, 2020·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Antonio C BossiUNKNOWN ANDREW study group
Feb 16, 2021·Journal of Microencapsulation·Luis Peña IcartLuís Maurício T R Lima
Jun 25, 2021·Expert Opinion on Pharmacotherapy·Mohamad Sirri TaraziAlpana P Shukla
Sep 18, 2021·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Sakiko TeruiJun Shirakawa

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NCT01769378

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