Trulicity ® (dulaglutid) injektion

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Trulicity® (dulaglutid): Användning med insulin glargin (AWARD-9)

Trulicity (dulaglutid) 1,5 mg minskade HbA1c signifikant jämfört med placebo vid 28 veckor vid tillsats till insulin glargin med eller utan metformin.

Detailed Information

A phase 3, double-blind, 28-week study (AWARD-9) evaluated the efficacy and safety of once-weekly dulaglutide 1.5 mg administered SC compared with once-weekly placebo when both were added to titrated daily IGlar with or without metformin in patients with T2DM.1

Treatment with dulaglutide 1.5 mg

  • was superior to treatment with placebo in mean change in HbA1c from baseline to 28 weeks (p<.001)

  • resulted in significantly greater reductions in mean FSG and mean BW from baseline to 28 weeks compared with placebo (p<.001), and

  • produced more patients that reached a HbA1c target of less than 7% or less than or equal to 6.5% from baseline, compared with placebo (p<.001) (Table 1).1

Table 1. Efficacy Parameters at Week 28 in AWARD-91

Parameter

Dulaglutide 1.5 mg

(n=150a)

Placebo

(n=150a)

Treatment Difference

ΔHbA1cb, %

-1.44±0.09

-0.67±0.09

-0.77±0.10c

ΔFSGb, mmol/L (mg/dL)

-2.48± 0.26 (-44.63±4.16)

-1.69 ± 0.26 (-27.90±4.08)

-1.05± 0.30 (-16.73±4.72)c

ΔBWb, kg

-1.91±0.30

+0.50±0.30

-2.41±0.39c

HbA1c <7%, % of patients

66.7c

33.3

---

HbA1c ≤6.5%, % of patients

50.0c

16.7

---

Abbreviations: Δ = change from baseline; AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes; BW = body weight; FSG = fasting serum glucose; HbA1c = glycated hemoglobin.

a Intent-to-treat population.

b Least-squares mean ± SE.

c p<.001, dulaglutide 1.5 mg vs placebo.

Increases in the mean IGlar dose were significantly smaller in the dulaglutide treatment group, 13±2 units, compared to the placebo group, 26±2 units, at 28 weeks (p<.001).1

The most frequent reasons for discontinuation were patient decision (dulaglutide 1.5 mg, n=3; placebo, n=7) and AE (dulaglutide 1.5 mg, n=6; placebo, n=2).1

TEAEs were reported in significantly more patients who received dulaglutide 1.5 mg, 64%, compared with patients who received placebo, 50% (p=.014).1

The most common TEAEs were GI in nature, and hypoglycemia TEAEs were similar between treatment groups.1

Information from the label

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.2

References

1. Pozzilli P, Norwood P, Jódar E, et al. Placebo-controlled, randomized trial of the addition of once-weekly glucagon-like peptide-1 receptor agonist dulaglutide to titrated daily insulin glargine in patients with type 2 diabetes (AWARD-9). Diabetes Obes Metab. 2017;19(7):1024-1031. http://dx.doi.org/10.1111/dom.12937

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

Glossary

AE = adverse event

AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes

BW = body weight

FSG = fasting serum glucose

GI = gastrointestinal

HbA1c = glycated hemoglobin

IGlar = insulin glargine

SC = subcutaneous

T2DM = type 2 diabetes mellitus

TEAE = treatment-emergent adverse event

Datum fӧr senaste ӧversyn 2019 M08 24


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