Trulicity ® (dulaglutid) injektion

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Trulicity® (dulaglutid): Långsiktig effekt

Behandling med dulaglutid 1,5 mg och 0,75 mg en gång i veckan visade en varaktig minskning av HbA1c vid 52 och 104 veckor.

Detailed Information

The AWARD-5 study was an adaptive, multicenter, randomized, 104-week, double-blind study that compared once-weekly dulaglutide 1.5 mg and dulaglutide 0.75 mg treatments with once-daily sitagliptin 100 mg and placebo in patients with T2DM inadequately controlled with metformin.1

Patients completing the 104-week treatment period included

  • 63% in the dulaglutide 1.5 mg group

  • 61% in the dulaglutide 0.75 mg group, and

  • 59% in the sitagliptin group.1,2

At 52 and 104 weeks, treatment with dulaglutide 1.5 mg and dulaglutide 0.75 mg once weekly resulted in a sustained reduction in

Table 1. Results of Primary and Secondary Outcomes at 52 and 104 Weeks in the AWARD-5 Study1-3

Outcomea

DULA 1.5 mg
(n=304)

DULA 0.75 mg
(n=302)

SITA 100 mg
(n=315)

Baseline to 52 Weeks

Change in HbA1c, %

-1.10b

-0.87b

-0.39

Proportion of patients who achieved target HbA1c <7.0% at 52 weeks, %

58b

49b

33

Proportion of patients who achieved target HbA1c ≤6.5% at 52 weeks, %

42b

29b

19

Change in FPG, mmol/L (mg/dL)

-2.39 (-43)b

-1.61 (-29)b

0.89 (-16)

Change in body weight, kg

-3.03b

-2.60b

-1.53

Baseline to 104 Weeks

Change in HbA1c, %

-0.99b

-0.71b

-0.32

Proportion of patients who achieved target HbA1c <7.0% at 104 weeks, %

54b

45b

31

Proportion of patients who achieved target HbA1c ≤6.5% at 104 weeks, %

39b

24b

14

Change in FPG, mmol/L (mg/dL)

-2.00 (-36)b

-1.39 (-25)b

-0.44 (-8)

Change in body weight, kg

-2.88b

-2.39

-1.75

Abbreviations: AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes; DULA = dulaglutide; FPG = fasting plasma glucose; HbA1c = glycated hemoglobin; SITA = sitagliptin.

a Data presented as least-squares mean of percent of patients.

b p<.001 compared with sitagliptin group.

References

1. Weinstock RS, Guerci B, Umpierrez G, et al. Safety and efficacy of once-weekly dulaglutide versus sitagliptin after 2 years in metformin-treated patients with type 2 diabetes (AWARD-5): a randomized, phase III study. Diabetes Obes Metab. 2015;17(9):849-858. http://dx.doi.org/10.1111/dom.12479

2. Nauck M, Weinstock RS, Umpierrez GE, et al. Efficacy and safety of dulaglutide versus sitagliptin after 52 weeks in type 2 diabetes in a randomized controlled trial (AWARD-5). Diabetes Care. 2014;37(8):2149-2158. http://dx.doi.org/10.2337/dc13-2761

3. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes

BW = body weight

FPG = fasting plasma glucose

HbA1c = glycated hemoglobin

T2DM = type 2 diabetes mellitus

Trulicity = Trulicity® (dulaglutide)

Datum fӧr senaste ӧversyn 2018 M11 13

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