A 24‐week study to evaluate the efficacy and safety of once‐weekly dulaglutide added on to glimepiride in type 2 diabetes (AWARD ‐8)

Jan 23, 2016Diabetes, obesity & metabolism

Once-weekly dulaglutide added to glimepiride for 24 weeks in type 2 diabetes: effectiveness and safety

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Abstract

Dulaglutide 1.5 mg reduced HbA1c by 1.3% compared to placebo over 24 weeks in patients with type 2 diabetes.

A higher proportion of participants taking dulaglutide achieved an HbA1c level of <7.0% compared to those on placebo (55.3% vs 18.9%).
Dulaglutide significantly lowered fasting serum glucose levels compared to placebo, with a difference of -1.86 mmol/l.
Weight decreased significantly in the dulaglutide group, although the difference compared to placebo was not statistically significant.
The most common side effects of dulaglutide included gastrointestinal issues such as nausea (10.5%) and diarrhea (8.4%).
There was a higher total incidence of hypoglycaemia with dulaglutide compared to placebo (2.37 vs 0.07 events/participant/year), though no severe hypoglycaemia was reported.

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AIMS: To evaluate the safety and efficacy of once-weekly dulaglutide 1.5 mg, a long-acting glucagon-like peptide-1 receptor agonist, compared with placebo in patients with type 2 diabetes (T2D) on glimepiride monotherapy.

METHODS: This phase III, randomized (4 : 1; dulaglutide:placebo), double-blind, placebo-controlled, 24-week study compared the safety and efficacy of once-weekly dulaglutide 1.5 mg with placebo in sulphonylurea-treated (≥half-maximal dose, stable ≥3 months) patients (N = 300) with T2D and inadequate glycaemic control [glycated haemoglobin (HbA1c) ≥7.5 and ≤9.5% (≥58 mmol/mol and ≤80 mmol/mol)]. Analysis was carried out according to intention-to-treat.

RESULTS: At baseline, the mean participant age was 58 years; mean HbA1c was 8.4% (68 mmol/mol) and mean weight was 85.5 kg. Dulaglutide 1.5 mg was superior to placebo at 24 weeks for HbA1c reduction from baseline with a between-group HbA1c difference of -1.3% [95% confidence interval (CI) -1.6, -1.0] or -14 mmol/mol (95% CI -17, -11); p < 0.001. A greater proportion of participants in the dulaglutide group reached an HbA1c level of <7.0% (53 mmol/mol) compared with placebo (55.3% vs 18.9%; p < 0.001). Dulaglutide significantly decreased fasting serum glucose from baseline compared with placebo (between-group difference -1.86 mmol/l (95% CI -2.58, -1.14) or -33.54 mg/dl (95% CI -46.55, -20.53); p < 0.001. Weight was decreased significantly from baseline in the dulaglutide group (p < 0.001); the between-group difference was not significant. The most common treatment-emergent adverse events for dulaglutide 1.5 mg were gastrointestinal: nausea (10.5%), diarrhoea (8.4%) and eructation (5.9%). Total hypoglycaemia was higher with dulaglutide 1.5 mg vs placebo (2.37 and 0.07 events/participant/year, respectively; p = 0.025). No severe hypoglycaemia was reported.

CONCLUSIONS: Once-weekly dulaglutide 1.5 mg had a favourable benefit/risk profile when added to glimepiride monotherapy.

Key numbers

-1.4%

HbA1c Reduction

Change from baseline for dulaglutide vs. placebo

55.3%

Proportion Achieving HbA1c Target

Participants achieving HbA1c <7.0%

-1.86 mmol/l

Fasting Serum Glucose Change

Change from baseline compared to placebo

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A 24‐week study to evaluate the efficacy and safety of once‐weekly dulaglutide added on to glimepiride in type 2 diabetes (AWARD ‐8)

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