Exenatide twice daily versus insulin glargine for the treatment of type 2 diabetes in Poland — subgroup data from a randomised multinational trial GWAA

Abstract

Introduction: We explored the safety and efficacy of exenatide BID v. insulin glargine in a subgroup of Polish patients with type 2 diabetes
sub-optimally controlled with metformin plus a sulfonylurea, participating in a 26-week randomised, controlled open-label trial.

Material and methods: In Poland, 80 patients (HbA1c 7–10%, BMI 25–45 kg/m2) were randomised to exenatide 10 μg BID (n = 40) or insulin
glargine once daily (n = 40). We present exploratory analyses on HbA1c, glucose profiles, body weight, hypoglycaemia and adverse events (AEs).

Results: Mean (SD) baseline HbA1c was 7.9% (0.86) for exenatide and 7.8% (1.02) for insulin glargine. At Week 26, LS mean (SEM) HbA1c
decreased in both groups (exenatide –0.72% [0.12]; glargine –0.64% [0.12]), as did fasting glucose. Postprandial glucose excursions after
breakfast and dinner were smaller in patients treated with exenatide. LS mean (SEM) body weight decreased by –1.9 (0.48) kg with exenatide
and increased by 1.6 (0.48) kg with glargine (group difference [95%CI]: –3.5 kg [–4.9 to –2.2]). Hypoglycaemia was low in both
groups; nocturnal hypoglycaemia was reported for three v. seven patients (three v. 24 episodes) in the exenatide and glargine groups,
respectively. Adverse events were more common with exenatide (nausea n = 22 v. n = 1, vomiting n = 5 v. n = 0, headache n = 8 v. n = 2).

Conclusion: This exploratory analysis confirms that findings from the global study apply to patients treated with exenatide BID and
glargine in Poland, showing that exenatide BID was as effective as insulin glargine. Data suggested that changes in HbA1c were similar,
with fasting glucose changes greater in the glargine group and postprandial changes greater in the exenatide BID group. Exenatide BID
was associated with weight reduction, less nocturnal hypoglycaemia, but more gastrointestinal events compared to glargine.

(Endokrynol Pol 2013; 64 (5): 375–382)