Once weekly glucagon-like peptide-1 receptor agonist albiglutide vs. prandial insulin added to basal insulin in patients with type 2 diabetes mellitus: Results over 52 weeks

https://doi.org/10.1016/j.jdiacomp.2017.05.010Get rights and content

Highlights

  • This was a 52-week extension of a previously reported 26-week study.

  • Albiglutide once weekly was compared with insulin lispro thrice daily.

  • Both treatments were added on to titrated insulin glargine.

  • Similar glycemic control was achieved with both treatments at week 52.

  • Albiglutide was associated with weight loss and less hypoglycemia but more GI events.

Abstract

We have previously reported that once-weekly albiglutide was noninferior to thrice-daily lispro for glycemic lowering, with decreased weight and risk of hypoglycemia, in patients inadequately controlled on basal insulin over 26 weeks. Findings after 52 weeks reveal similar responses to albiglutide as an add-on to insulin glargine.

Introduction

Albiglutide once weekly (QW) was compared with prandial insulin lispro three times daily, both combined with titrated insulin glargine, in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with basal insulin with or without oral antidiabetic agents (OADs). After 26 weeks, albiglutide was noninferior for glycemic lowering (primary endpoint) and was associated with weight loss and reduced risk of hypoglycemia, but it caused more gastrointestinal (GI) adverse events (AEs) and injection-site reactions (ISRs) compared with insulin lispro.1 Here, we report the prespecified 52-week results of this trial.

Section snippets

Materials and methods

Detailed study methodology was reported previously.1 Briefly, adult patients with T2DM inadequately controlled with insulin with or without OADs for ≥ 6 months and < 5 years (HbA1c, 53.0–91.3 mmol/mol [7–10.5%]) were randomized in an open-label, parallel-group, multicenter, phase 3 trial consisting of four periods: screening, run-in (stabilization to insulin glargine with current regimen of OADs), 52-week treatment, and 8-week follow-up.

Albiglutide could be uptitrated from 30 to 50 mg QW after week

Patients

Baseline demographics and characteristics were well matched between treatment groups (overall mean age, 55.6 years; weight, 92.1 kg; HbA1c, 69.4 mmol/mol [8.5%]; and diabetes duration, 11.1 years). The mean (standard deviation [SD]) duration of exposure was 325.2 (91.64) days in the albiglutide group and 337.5 (80.8) days in the insulin lispro group.

Study treatments

The mean daily doses of insulin glargine at baseline and week 52, respectively, were 47.0 IU and 55.3 IU in the albiglutide group and 43.3 IU and 53.0 IU

Discussion

At week 52, both once-weekly albiglutide and thrice-daily insulin lispro, each in combination with titrated insulin glargine, demonstrated sustained glycemic control, with similar titration of basal insulin. In phase 3 studies, sustained reductions in glycemic parameters and body weight have been seen with albiglutide for periods as long as 3 years2 and similar results have also been observed with other GLP-1RAs (eg., exenatide, liraglutide, dulaglutide, and lixisenatide) for periods ranging

Conclusion

In combination with insulin glargine, once-weekly albiglutide and thrice-daily insulin lispro demonstrated comparable durable glycemic control over 52 weeks. With a simpler regimen, albiglutide can potentially improve patient adherence.

Author contributions

LAL contributed to the study design, data collection, and interpretation of the study results and the writing of the manuscript and approved the final version of this manuscript for submission. JLG contributed to the data collection and interpretation of the study results and approved the final version of this manuscript for submission. BA contributed to the study design, data collection, and interpretation of the results and the writing of the manuscript and approved the final version of this

Acknowledgements

This study was funded by GlaxoSmithKline; clinical trial registration number: NCT00976391 (clinicaltrials.gov).

The authors thank Douglas L. Wicks, MPH, CMPP (employee of GlaxoSmithKline), for managing the manuscript development. Editorial support, which was funded by GlaxoSmithKline, was provided by Joelle Suchy, PhD, and Linda Feighery, PhD, at MediTech Media, Hamilton, NJ (helped to produce the draft outline and first draft of the manuscript, assemble tables, and collate the authors'

References (3)

  • J. Rosenstock et al.

    Harmony 6 study group. Advancing basal insulin replacement in type 2 diabetes inadequately controlled with insulin glargine plus oral agents: a comparison of adding albiglutide, a weekly GLP-1 receptor agonist, versus thrice-daily prandial insulin lispro

    Diabetes Care

    (2014)
There are more references available in the full text version of this article.

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Conflict of Interest: LAL has received research funding from, has provided CME on behalf of, and/or has acted as a consultant to AstraZeneca, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Janssen, Merck, Novo Nordisk, Pfizer, Sanofi, Servier, and Takeda. JLG has received honoraria and/or grants/research support for serving on scientific advisory boards from the GLP-1RA manufacturers Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Novo Nordisk, and Roche. BA has received honoraria for lecturing and/or consultancy from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Merck, Novartis, Novo Nordisk, Sanofi, and Takeda. FC has received research support from Boehringer Ingelheim, GlaxoSmithKline, Merck, Novartis, NovoNordisk, Sanofi, and Takeda and has served on scientific advisory boards for Boehringer Ingelheim, Eli Lilly, Merck, Novartis, and Novo Nordisk. SJ was an employee of and was a shareholder in GlaxoSmithKline. DM is an employee and shareholder in GlaxoSmithKline.

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