The fate of taspoglutide, a weekly GLP-1 receptor agonist, versus twice-daily exenatide for type 2 diabetes: the T-emerge 2 trial

Abstract

Objective: Taspoglutide is a long-acting glucagon-like peptide 1 receptor agonist developed for treatment of type 2 diabetes. The efficacy and safety of once-weekly taspoglutide was compared with twice-daily exenatide.

Research design and methods: Overweight adults with inadequately controlled type 2 diabetes on metformin ± a thiazolidinedione were randomized to subcutaneous taspoglutide 10 mg weekly (n = 399), taspoglutide 20 mg weekly (n = 398), or exenatide 10 µg twice daily (n = 392) in an open-label, multicenter trial. The primary end point was change in HbA(1c) after 24 weeks.

Results: Mean baseline HbA(1c) was 8.1%. Both doses of taspoglutide reduced HbA(1c) significantly more than exenatide (taspoglutide 10 mg: -1.24% [SE 0.09], difference -0.26, 95% CI -0.37 to -0.15, P < 0.0001; taspoglutide 20 mg: -1.31% [0.08], difference -0.33, -0.44 to -0.22, P < 0.0001; exenatide: -0.98% [0.08]). Both taspoglutide doses reduced fasting plasma glucose significantly more than exenatide. Taspoglutide reduced body weight (taspoglutide 10 mg, -1.6 kg; taspoglutide 20 mg, -2.3 kg) as did exenatide (-2.3 kg), which was greater than with taspoglutide 10 mg (P < 0.05). HbA(1c) and weight effects were maintained after 52 weeks. More adverse events with taspoglutide 10 and 20 mg than exenatide developed over time (nausea in 53, 59, and 35% and vomiting in 33, 37, and 16%, respectively). Allergic and injection-site reactions were more common with taspoglutide. Discontinuations were greater with taspoglutide. Antitaspoglutide antibodies were detected in 49% of patients.

Conclusions: Once-weekly taspoglutide demonstrated greater glycemic control than twice-daily exenatide with comparable weight loss, but with unacceptable levels of nausea/vomiting, injection-site reactions, and systemic allergic reactions.

Trial registration: ClinicalTrials.gov NCT00717457.

Figures

Figure 1

Glycemic control and body weight. A: HbA1c values from baseline to week 52. B: Change in HbA1c values from baseline to weeks 24 and 52. C: Fasting plasma glucose concentrations from baseline to week 52. D: Change in fasting plasma glucose concentrations from baseline to weeks 24 and 52. E: Body weight from baseline to week 52. F: Change in body weight from baseline to weeks 24 and 52. A, C, and E: Open circle, taspoglutide 10 mg once weekly (n = 384), baseline 8.1%; closed circle, taspoglutide 20 mg once weekly (n = 392), baseline 8.1%; open square, exenatide 10 μg twice daily (n = 373), baseline 8.1%. B, D, and F: White bar, taspoglutide 10 mg; black bar, taspoglutide 20 mg; striped bar, exenatide.