Philip D Home1, Bo Ahrén2, Jane E B Reusch3, Marc Rendell4, Peter N Weissman5, Deborah T Cirkel6, Diane Miller7, Philip Ambery8, Molly C Carr9, Michael A Nauck10. 1. Institute of Cellular Medicine - Diabetes, Newcastle University, Newcastle upon Tyne, UK. Electronic address: philip.home@ncl.ac.uk. 2. Department of Clinical Sciences, Division of Medicine, Lund University, Lund, Sweden. Electronic address: Bo.Ahren@med.lu.se. 3. Denver Veterans Administration Medical Center, Denver, CO, USA. Electronic address: Jane.Reusch@ucdenver.edu. 4. Division of Endocrinology, Department of Medicine, Creighton University, Omaha, NE, USA. Electronic address: rendell@asndi.com. 5. Endocrinology Associates, Miami, FL, USA. Electronic address: peternweissman@att.net. 6. Pharma Research & Development, GlaxoSmithKline, Stevenage, UK. Electronic address: Deborah.T.Cirkel@gsk.com. 7. Pharma Research & Development, GlaxoSmithKline, Collegeville, PA, USA. Electronic address: diane.m.miller@gsk.com. 8. Pharma Research & Development, GlaxoSmithKline, King of Prussia, PA, USA. Electronic address: melphila@hotmail.com. 9. Pharma Research & Development, GlaxoSmithKline, Collegeville, PA, USA. Electronic address: molly.c.carr@gsk.com. 10. Division of Diabetology, Medical Department I, St. Josef-Hospital, Ruhr-Universität, Bochum, Germany. Electronic address: michael.nauck@rub.de.
Abstract
AIMS: Diabetes therapies that provide durable glycaemic control for people with type 2 diabetes mellitus (T2DM) are needed. We present efficacy results of albiglutide, a glucagon-like peptide-1 receptor agonist, in people with T2DM over a 3-year period. METHODS: Five of the 8 HARMONY phase 3 trials, comparing albiglutide with other therapies or placebo across a spectrum of clinical care, lasted for a preplanned 3years. Participants with uncontrolled hyperglycaemia who met predetermined criteria could receive rescue medication. The ability to remain on study medication without needing additional rescue was an efficacy measure. Glycaemic measures and body weight were analysed in 2 populations: those who remained rescue-free and all participants. RESULTS:Participants (n=3132) were randomised to albiglutide or comparator. A greater proportion of participants who received albiglutide remained rescue-free (55-71%) compared with placebo (35-51%; p<0.001 to p=0.002). The proportion of rescue-free participants with albiglutide did not differ from glimepiride or insulin glargine, was higher than with sitagliptin (p=0.013), and lower than with pioglitazone (p=0.045). At 3years, albiglutide was associated with clinically significant reductions in hyperglycaemia (eg, rescue-free participants: HbA1c -0.52% [SE0.11] to -0.98% [0.12]; -5.7mmol/mol [1.2] to -10.7mmol/mol [1.3] and all participants: HbA1c -0.29% [0.11] to-0.92% [0.13]; -3.2mmol/mol [1.2] to -10.1mmol/mol [1.4]). Albiglutide was also associated with modest reductions in body weight vs pioglitazone, glimepiride, and insulin glargine, which were associated with weight gain. CONCLUSION: These 3-year efficacy data support long-term use of albiglutide in the management of people with T2DM. ClinicalTrials.gov NCT00849056, NCT00849017, NCT00838903, NCT00838916, NCT00839527.
RCT Entities:
AIMS: Diabetes therapies that provide durable glycaemic control for people with type 2 diabetes mellitus (T2DM) are needed. We present efficacy results of albiglutide, a glucagon-like peptide-1 receptor agonist, in people with T2DM over a 3-year period. METHODS: Five of the 8 HARMONY phase 3 trials, comparing albiglutide with other therapies or placebo across a spectrum of clinical care, lasted for a preplanned 3years. Participants with uncontrolled hyperglycaemia who met predetermined criteria could receive rescue medication. The ability to remain on study medication without needing additional rescue was an efficacy measure. Glycaemic measures and body weight were analysed in 2 populations: those who remained rescue-free and all participants. RESULTS:Participants (n=3132) were randomised to albiglutide or comparator. A greater proportion of participants who received albiglutide remained rescue-free (55-71%) compared with placebo (35-51%; p<0.001 to p=0.002). The proportion of rescue-free participants with albiglutide did not differ from glimepiride or insulinglargine, was higher than with sitagliptin (p=0.013), and lower than with pioglitazone (p=0.045). At 3years, albiglutide was associated with clinically significant reductions in hyperglycaemia (eg, rescue-free participants: HbA1c -0.52% [SE0.11] to -0.98% [0.12]; -5.7mmol/mol [1.2] to -10.7mmol/mol [1.3] and all participants: HbA1c -0.29% [0.11] to-0.92% [0.13]; -3.2mmol/mol [1.2] to -10.1mmol/mol [1.4]). Albiglutide was also associated with modest reductions in body weight vs pioglitazone, glimepiride, and insulinglargine, which were associated with weight gain. CONCLUSION: These 3-year efficacy data support long-term use of albiglutide in the management of people with T2DM. ClinicalTrials.gov NCT00849056, NCT00849017, NCT00838903, NCT00838916, NCT00839527.
Authors: Bernard Zinman; Michael A Nauck; Heidrun Bosch-Traberg; Helle Frimer-Larsen; David D Ørsted; John B Buse Journal: Diabetes Ther Date: 2018-11-03 Impact factor: 2.945
Authors: Jason Fan; Wen Du; Ja Young Kim-Muller; Jinsook Son; Taiyi Kuo; Delfina Larrea; Christian Garcia; Takumi Kitamoto; Michael J Kraakman; Edward Owusu-Ansah; Vincenzo Cirulli; Domenico Accili Journal: Mol Metab Date: 2020-02-04 Impact factor: 7.422