Efficacy and safety of subgroup analysis stratified by baseline HbA1c in a Japanese phase 3 study of dulaglutide 0.75 mg compared with insulin glargine in patients with type 2 diabetes

Sep 15, 2017Endocrine journal

Effectiveness and safety of dulaglutide 0.75 mg versus insulin glargine by starting blood sugar levels in Japanese patients with type 2 diabetes

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Abstract

Dulaglutide 0.75 mg resulted in a statistically significantly greater reduction in HbA1c compared to insulin glargine after 26 weeks in patients with type 2 diabetes.

Patients with baseline HbA1c ≤8.5% experienced a reduction of -1.27% with dulaglutide versus -0.72% with glargine.
In patients with baseline HbA1c >8.5%, dulaglutide led to a reduction of -2.04%, compared to -1.47% with glargine.
Dulaglutide treatment was associated with weight loss, while glargine treatment resulted in weight gain in both HbA1c subgroups.
Both treatment groups showed similar reductions in fasting blood glucose, but dulaglutide provided a greater reduction in postprandial blood glucose.
While dulaglutide increased mild gastrointestinal adverse events, these were generally well tolerated.
Dulaglutide was associated with a lower incidence of hypoglycemia compared to glargine.

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The efficacy and safety of once-weekly dulaglutide 0.75 mg (dulaglutide) compared with once-daily insulin glargine (glargine) in Japanese patients with type 2 diabetes were evaluated according to subgroups stratified by baseline glycated hemoglobin (HbA1c) (≤8.5% or >8.5%). This exploratory analysis of a randomized, open-label, phase 3 study included 361 patients. In both HbA1c subgroups (patients with baseline HbA1c ≤8.5% or >8.5%), a statistically significantly greater reduction in HbA1c was observed in dulaglutide-treated patients compared with glargine-treated patients after 26 weeks of treatment (HbA1c ≤8.5%: dulaglutide, -1.27%; glargine, -0.72%; HbA1c >8.5%: dulaglutide, -2.04%; glargine, -1.47%; p < 0.001 for both). Mean body weight was decreased from baseline in both subgroups of the dulaglutide group and increased in both subgroups of the glargine group; there were statistically significant differences between the treatment groups in both subgroups (p < 0.05 for both). In both subgroups, similar reductions in fasting blood glucose were observed for dulaglutide- and glargine-treated patients, and a greater reduction in postprandial blood glucose was observed for dulaglutide-treated patients compared with glargine-treated patients. Although dulaglutide increased gastrointestinal adverse events compared with glargine in both subgroups, all gastrointestinal events of diarrhea, nausea, constipation, and vomiting in dulaglutide-treated patients were mild in intensity and well tolerated. In both subgroups, there was a lower incidence of hypoglycemia with dulaglutide than with glargine. Dulaglutide demonstrated significantly greater HbA1c reduction compared with glargine, with an acceptable safety profile, regardless of baseline HbA1c.

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Efficacy and safety of subgroup analysis stratified by baseline HbA1c in a Japanese phase 3 study of dulaglutide 0.75 mg compared with insulin glargine in patients with type 2 diabetes

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