Efficacy and safety of once-weekly GLP-1 receptor agonist albiglutide (HARMONY 2): 52 week primary endpoint results from a randomised, placebo-controlled trial in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise

Michael A. Nauck, Murray W. Stewart, Christopher Perkins, Angela Jones-Leone, Fred Yang, Caroline Perry, Rickey R. Reinhardt, Marc Rendell

Research output: Contribution to journalArticle

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Abstract

Aims/hypothesis: Additional safe and effective therapies for type 2 diabetes are needed, especially ones that do not cause weight gain and have a low risk of hypoglycaemia. The present study evaluated albiglutide as monotherapy. Methods: In this placebo-controlled study, 309 patients (aged ≥18 years) with type 2 diabetes inadequately controlled by diet and exercise and who were not using a glucose-lowering agent (HbA1c 7.0–10.0% [53.00–85.79 mmol/mol], body mass index 20–45 kg/m2, and fasting C-peptide ≥0.26 nmol/l) were randomised (1:1:1 on a fixed randomisation schedule using an interactive voice response system) to receive once-weekly albiglutide 30 mg (n = 102) or 50 mg (n = 102) or matching placebo (n = 105). The study treatments were blinded to both patients and study personnel. All study data were collected at individual patient clinic visits. The primary efficacy endpoint was change in HbA1c from baseline to week 52. The primary analysis was applied to the intent-to-treat population. Additional efficacy and safety endpoints were assessed. Results: At week 52, both albiglutide 30 mg and 50 mg were superior to placebo in reducing HbA1c. The least-squares means treatment difference from placebo was −0.84% (95% CI −1.11%, −0.58%; p <0.0001) with albiglutide 30 mg and −1.04% (−1.31%, −0.77%; p <0.0001) with albiglutide 50 mg. Injection-site reactions were reported more frequently with albiglutide (30 mg: 17.8%; 50 mg: 22.2%) than with placebo (9.9%). Other commonly reported adverse events included nausea, diarrhoea, vomiting and hypoglycaemia; the incidences of these were generally similar across treatment groups. Conclusions/interpretation: Albiglutide is safe and effective as monotherapy and significantly lowered HbA1c levels over 52 weeks, did not cause weight gain, and had good gastrointestinal tolerability and a low rate of hypoglycaemia compared with placebo. Trial registration ClinicalTrials.gov NCT00849017 Funding This study was sponsored by GlaxoSmithKline.

Original languageEnglish
Pages (from-to)266-274
Number of pages9
JournalDiabetologia
Volume59
Issue number2
DOIs
StatePublished - Feb 1 2016

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Type 2 Diabetes Mellitus
Randomized Controlled Trials
Placebos
Exercise
Diet
Safety
Hypoglycemia
Weight Gain
C-Peptide
Therapeutics
Ambulatory Care
Random Allocation
rGLP-1 protein
Glucagon-Like Peptide-1 Receptor
Least-Squares Analysis
Nausea
Vomiting
Diarrhea
Fasting
Appointments and Schedules

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism

Cite this

Efficacy and safety of once-weekly GLP-1 receptor agonist albiglutide (HARMONY 2) : 52 week primary endpoint results from a randomised, placebo-controlled trial in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. / Nauck, Michael A.; Stewart, Murray W.; Perkins, Christopher; Jones-Leone, Angela; Yang, Fred; Perry, Caroline; Reinhardt, Rickey R.; Rendell, Marc.

In: Diabetologia, Vol. 59, No. 2, 01.02.2016, p. 266-274.

Research output: Contribution to journalArticle

Nauck, Michael A. ; Stewart, Murray W. ; Perkins, Christopher ; Jones-Leone, Angela ; Yang, Fred ; Perry, Caroline ; Reinhardt, Rickey R. ; Rendell, Marc. / Efficacy and safety of once-weekly GLP-1 receptor agonist albiglutide (HARMONY 2) : 52 week primary endpoint results from a randomised, placebo-controlled trial in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. In: Diabetologia. 2016 ; Vol. 59, No. 2. pp. 266-274.
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abstract = "Aims/hypothesis: Additional safe and effective therapies for type 2 diabetes are needed, especially ones that do not cause weight gain and have a low risk of hypoglycaemia. The present study evaluated albiglutide as monotherapy. Methods: In this placebo-controlled study, 309 patients (aged ≥18 years) with type 2 diabetes inadequately controlled by diet and exercise and who were not using a glucose-lowering agent (HbA1c 7.0–10.0{\%} [53.00–85.79 mmol/mol], body mass index 20–45 kg/m2, and fasting C-peptide ≥0.26 nmol/l) were randomised (1:1:1 on a fixed randomisation schedule using an interactive voice response system) to receive once-weekly albiglutide 30 mg (n = 102) or 50 mg (n = 102) or matching placebo (n = 105). The study treatments were blinded to both patients and study personnel. All study data were collected at individual patient clinic visits. The primary efficacy endpoint was change in HbA1c from baseline to week 52. The primary analysis was applied to the intent-to-treat population. Additional efficacy and safety endpoints were assessed. Results: At week 52, both albiglutide 30 mg and 50 mg were superior to placebo in reducing HbA1c. The least-squares means treatment difference from placebo was −0.84{\%} (95{\%} CI −1.11{\%}, −0.58{\%}; p <0.0001) with albiglutide 30 mg and −1.04{\%} (−1.31{\%}, −0.77{\%}; p <0.0001) with albiglutide 50 mg. Injection-site reactions were reported more frequently with albiglutide (30 mg: 17.8{\%}; 50 mg: 22.2{\%}) than with placebo (9.9{\%}). Other commonly reported adverse events included nausea, diarrhoea, vomiting and hypoglycaemia; the incidences of these were generally similar across treatment groups. Conclusions/interpretation: Albiglutide is safe and effective as monotherapy and significantly lowered HbA1c levels over 52 weeks, did not cause weight gain, and had good gastrointestinal tolerability and a low rate of hypoglycaemia compared with placebo. Trial registration ClinicalTrials.gov NCT00849017 Funding This study was sponsored by GlaxoSmithKline.",
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AU - Nauck, Michael A.

AU - Stewart, Murray W.

AU - Perkins, Christopher

AU - Jones-Leone, Angela

AU - Yang, Fred

AU - Perry, Caroline

AU - Reinhardt, Rickey R.

AU - Rendell, Marc

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N2 - Aims/hypothesis: Additional safe and effective therapies for type 2 diabetes are needed, especially ones that do not cause weight gain and have a low risk of hypoglycaemia. The present study evaluated albiglutide as monotherapy. Methods: In this placebo-controlled study, 309 patients (aged ≥18 years) with type 2 diabetes inadequately controlled by diet and exercise and who were not using a glucose-lowering agent (HbA1c 7.0–10.0% [53.00–85.79 mmol/mol], body mass index 20–45 kg/m2, and fasting C-peptide ≥0.26 nmol/l) were randomised (1:1:1 on a fixed randomisation schedule using an interactive voice response system) to receive once-weekly albiglutide 30 mg (n = 102) or 50 mg (n = 102) or matching placebo (n = 105). The study treatments were blinded to both patients and study personnel. All study data were collected at individual patient clinic visits. The primary efficacy endpoint was change in HbA1c from baseline to week 52. The primary analysis was applied to the intent-to-treat population. Additional efficacy and safety endpoints were assessed. Results: At week 52, both albiglutide 30 mg and 50 mg were superior to placebo in reducing HbA1c. The least-squares means treatment difference from placebo was −0.84% (95% CI −1.11%, −0.58%; p <0.0001) with albiglutide 30 mg and −1.04% (−1.31%, −0.77%; p <0.0001) with albiglutide 50 mg. Injection-site reactions were reported more frequently with albiglutide (30 mg: 17.8%; 50 mg: 22.2%) than with placebo (9.9%). Other commonly reported adverse events included nausea, diarrhoea, vomiting and hypoglycaemia; the incidences of these were generally similar across treatment groups. Conclusions/interpretation: Albiglutide is safe and effective as monotherapy and significantly lowered HbA1c levels over 52 weeks, did not cause weight gain, and had good gastrointestinal tolerability and a low rate of hypoglycaemia compared with placebo. Trial registration ClinicalTrials.gov NCT00849017 Funding This study was sponsored by GlaxoSmithKline.

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