A total of 737 patients were randomized, showing that dulaglutide significantly improved blood sugar control compared to glimepiride.
Both doses of dulaglutide (1.5 mg and 0.75 mg) reduced glycated hemoglobin () more effectively than glimepiride.
The least squares mean difference for HbA1c reduction was -6.34 mmol/mol (or -0.58%) for dulaglutide 1.5 mg and -3.50 mmol/mol (or -0.32%) for dulaglutide 0.75 mg.
74.1% of patients on dulaglutide 1.5 mg reached the HbA1c target of <53 mmol/mol (<7.0%), compared to 57.4% on glimepiride.
Mean body weight decreased in patients taking dulaglutide, and total hypoglycemia rates were lower than in the glimepiride group.
Common side effects in the dulaglutide groups included diarrhea, nausea, and decreased appetite.
Simplified
AIMS: To compare the efficacy and safety of once-weekly glucagon-like peptide-1 receptor agonist dulaglutide 1.5 and 0.75 mg with glimepiride in East-Asian patients with type 2 diabetes (T2D).
MATERIALS AND METHODS: In this phase III, multinational, multicentre, double-blind, randomized, parallel-arm, 26-week study, patients with inadequate glycaemic control were randomized 1:1:1 to once-weekly dulaglutide 1.5 or 0.75 mg or daily glimepiride (1-3 mg/d). The primary endpoint was assessment of the non-inferiority of dulaglutide (1.5 mg), as measured by change in glycated haemoglobin (), compared with glimepiride using a 0.4% non-inferiority margin.
RESULTS: A total of 737 patients were randomized (dulaglutide 1.5 mg, n = 244; dulaglutide 0.75 mg, n = 248; glimepiride, n = 245). At week 26, both doses of dulaglutide were non-inferior and also superior to glimepiride for HbA1c reduction from baseline with a least squares mean difference of -6.34 mmol/mol (95% confidence interval [CI] -8.31, -4.26) or -0.58% (95% CI -0.76, -0.39) for dulaglutide 1.5 mg and -3.50 mmol/mol (95% CI -5.47, -1.42) or -0.32% (95% CI -0.50, -0.13) for dulaglutide 0.75 mg (P < .001). A greater proportion of patients in the dulaglutide 1.5 mg group achieved the HbA1c target of <53 mmol/mol (<7.0%) compared with the glimepiride group (74.1% vs 57.4%; P < .001). The mean body weight decreased (P < .005) and total hypoglycaemia rates were lower (P < .001) in the dulaglutide groups compared with the glimepiride group. The most common drug-related adverse events in both dulaglutide groups (≥5% of patients) included diarrhoea, nausea, increased lipase, decreased appetite, abdominal distension and vomiting.
CONCLUSIONS: Dulaglutide (both doses) demonstrated superior glycaemic control vs glimepiride, with a favourable tolerability and safety profile in East-Asian patients with T2D.
Key numbers
-6.34 mmol/mol
Reduction with Dulaglutide 1.5 mg
Least squares mean difference from baseline at week 26.
74.1%
Target Achievement
Proportion of patients achieving <53 mmol/mol at week 26.
0.14 events/patient/year
Total Hypoglycemia Rates
Mean rates in the dulaglutide 1.5 mg group.
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L.G., F.W. and J.Y. are employees of Eli Lilly and Company. P.L was an employee of Eli Lilly and Company at the time of manuscript preparation. Y.H.C., C‐N.H., Y.M.C. and W.Q.W. have nothing to disclose.
