Trulicity ® (dulaglutid) injektion

För fullständig produktresumé för Trulicity® se FASS.

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Trulicity® (dulaglutid): Användning med Insulin Lispro

Dulaglutid 1,5 mg och 0,75 mg en gång i veckan studerades i kombination med insulin lispro

Study Design

AWARD-4, a phase 3, open-label, 52-week study, evaluated the efficacy and safety of once-weekly dulaglutide 1.5 mg or dulaglutide 0.75 mg treatment in comparison with daily basal insulin glargine treatment, both in combination with prandial insulin lispro with or without metformin, in patients with T2DM .1

Patients were randomized (1:1:1) to one of the following treatment groups

  • once-weekly dulaglutide 1.5 mg SC (n=295)

  • once-weekly dulaglutide 0.75 mg SC (n=293), or

  • daily insulin glargine SC (n=296).1

All patients also used insulin lispro with 3 largest meals of the day.1

The insulin glargine dose was titrated using a treat-to-target algorithm based on the median of the previous 3 fasting glucose values.1 The insulin lispro dose was titrated using the algorithm proposed by Bergenstal et al.2

The primary outcome was change in HbA1c from baseline to 26 weeks.1

Efficacy Results

Both dulaglutide 1.5 mg and dulaglutide 0.75 mg treatment were superior (p<.025) to insulin glargine in the change in HbA1c from baseline at 26 weeks and 52 weeks (Table 1. HbA1c Outcomes at 26 and 52 Weeks, in the AWARD-4 Study).1

Table 1. HbA1c Outcomes at 26 and 52 Weeks, in the AWARD-4 Study1

Time Point

DU 1.5 mg

N=295

DU 0.75 mg

N=293

GLA

N=296

P Value

LSM change from baseline for HbA1c (%)a

26 weeks

-1.64

-1.59

-1.41

<.025 superiority of DU 1.5 mg and DU 0.75 mg vs GLA

52 weeks

-1.48

-1.42

-1.23

<.025 superiority of DU 1.5 mg and DU 0.75 mg vs GLA

Abbreviations: DU = dulaglutide; GLA = insulin glargine; HbA1c = glycated hemoglobin; LSM = least-squares mean.

a LSM adjusted for baseline value and other stratification factors.

Safety Results

At 52 weeks, TEAEs were reported in

  • 74% of patients receiving dulaglutide 1.5 mg

  • 78% of patients receiving dulaglutide 0.75 mg, and

  • 70% of patients receiving insulin glargine.1

The rate of total hypoglycemic events was significantly (p=0.0008) higher with insulin glargine treatment compared with dulaglutide 1.5 mg treatment.1

Precaution

Patients receiving dulaglutide in combination with sulphonylurea or insulin may have an increased risk of hypoglycaemia. The risk of hypoglycaemia may be lowered by a reduction in the dose of sulphonylurea or insulin.3

References

1. Blonde L, Jendle J, Gross J, et al. Once-weekly dulaglutide versus bedtime insulin glargine, both in combination with prandial insulin lispro, in patients with type 2 diabetes (AWARD-4): a randomised, open-label, phase 3, non-inferiority study. Lancet. 2015;385(9982):2057-2066. https://doi.org/10.1016/S0140-6736(15)60936-9

2. Bergenstal R, Johnson MA, Powers M, et al. Adjust to target in type 2 diabetes: comparison of a simple algorithm with carbohydrate counting for adjustment of mealtime insulin glulisine. Diabetes Care. 2008;31(7):1305-1310. http://dx.doi.org/10.2337/dc07-2137

3. Trulicity [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

Glossary

AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes

HbA1c = glycated hemoglobin

SC = subcutaneous

T2DM = type 2 diabetes mellitus

TEAE = treatment-emergent adverse event

Datum fӧr senaste ӧversyn 2019 M01 22


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