Once-weekly dulaglutide (DU) vs. insulin glargine in the control of fasting serum glucose and hypoglycaemia rate in the first 20 weeks in patients with type 2 diabetes mellitus on metformin and glimepiride

Research Question:

In the 78-week AWARD-2 study, once-weekly DU 1.5 mg was more effective than insulin glargine (GLA) in reducing HbA1c, with lower hypoglycaemia risk. This post-hoc analysis examined the effect on control of fasting serum glucose (FSG) and hypoglycaemia rate (episodes (blood glucose ≤70 mg/dL)/patient/week) during the first 20 weeks.

Methodology:

810 patients were randomised to DU 1.5 mg, DU 0.75 mg, or GLA (dose titration). Patients with FSG < 130 mg/dL were identified at weeks 2, 4, 8, 14 and 20. Mean weekly hypoglycaemia rate, mean glimepiride and GLA doses were documented at each visit.

Findings:

For DU 1.5 mg and 0.75 mg, percentage of patients with FSG < 130 mg/dL was highest at Week 2 (58.9% and 53.7%, respectively), stabilising by Week 20 (55.0% and 47.2%, respectively) while for GLA, it was 44.4% at Week 2, increasing to 54.7% at Week 20. Mean weekly hypoglycaemia rates (episodes/patient/week in patients with FSG< 130 mg/dL) at Weeks 2 and 20, respectively, were 0.47 and 0.11 (DU 1.5 mg), 0.33 and 0.13 (DU 0.75 mg), and 0.27 and 0.23 (GLA); DU 1.5 mg vs. GLA at Week 2, p = 0.0104; Week 20, p = 0.0169. Severe hypoglycaemia was minimal. Odds ratios (95% CI) for probability of reaching FSG < 130 mg/dL without hypoglycaemia (DU 1.5 mg vs. GLA): Week 2, 1.31 (0.91 – 1.89); Week 4, 1.78 (1.22 – 2.60); Week 8, 1.69 (1.15 – 2.48); Week 14, 1.46 (0.99 – 2.17); Week 20, 1.36 (0.93 – 2.00).

Conclusion:

In this analysis, there was a higher probability of reaching FSG < 130 mg/dL without hypoglycaemia with DU 1.5 mg vs. GLA in the early weeks of treatment.