Trulicity ® (dulaglutid) injektion

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Trulicity® (dulaglutid): Jämförelse med Sitagliptin (AWARD-5)

Minskningen av HbA1c vid 52 och 104 veckor var signifikant större hos patienter behandlade med dulaglutid och metformin jämfört med de som behandlades med sitagliptin och metformin.

Study Design

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

The study consisted of a lead-in period of up to 11 weeks, during which patients’ metformin was titrated to stable (≥1500 mg/day) doses for at least 6 weeks before randomization, and other OAMs were discontinued. After the lead-in period, patients were randomly assigned to receive once-weekly dulaglutide 1.5 mg, once-weekly dulaglutide 0.75 mg, once-daily sitagliptin 100 mg, or placebo in a ratio of 2:2:2:1. Placebo-treated patients continued treatment until week 26 and were then switched to sitagliptin in a blinded manner.2

The primary objective of the AWARD-5 study was to show noninferiority of once-weekly dulaglutide 1.5 mg treatment to sitagliptin for change in HbA1c at 52 weeks.2

Efficacy Results

Treatment with dulaglutide 1.5 mg and dulaglutide 0.75 mg once weekly both resulted in significantly greater reductions in HbA1c levels from baseline to 52 weeks and 104 weeks than did treatment with sitagliptin (p<.001) (Table 1. Change in HbA1c From Baseline to 52 and 104 Weeks With Dulaglutide and Sitagliptin in AWARD-5).1-3

Table 1. Change in HbA1c From Baseline to 52 and 104 Weeks With Dulaglutide and Sitagliptin in AWARD-51-3

HbA1c (%)a

DULA 1.5 mg
(n=304)

DULA 0.75 mg
(n=302)

SITA 100 mg
(n=315)

52 weeks

-1.10b

-0.87b

-0.39

104 weeks

-0.99b

-0.71b

-0.32

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

a Percentage is LSM reduction in HbA1c from baseline.

b p<.001 compared with sitagliptin group.

Safety Results

Treatment with dulaglutide was associated with a significantly higher incidence of GI TEAEs than treatment with sitagliptin (p<.05).1,2

Nausea, diarrhea, and vomiting were the most commonly reported AEs with the incidence highest after 2 weeks of treatment and decreased at the following visits.1

Hypoglycemia was defined as blood glucose ≤70 mg/dL and/or signs/symptoms consistent with hypoglycemia. Severe hypoglycemia was defined as any episode that required assistance from another person to administer treatment.2 

The incidence of hypoglycemia at 104 weeks was 12.8% for dulaglutide 1.5 mg, 8.6% for dulaglutide 0.75 mg, and 8.6% for sitagliptin.1,2

There were no severe hypoglycemic events reported in the AWARD-5 study.1,2

Adjudication-confirmed acute pancreatitis was reported in 2 patients who were taking sitagliptin.1,2

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

Glossary

AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes

AE = adverse event

GI = gastrointestinal

HbA1c = glycated hemoglobin

OAM = oral antihyperglycemic medication

T2DM = type 2 diabetes mellitus

TEAE = treatment-emergent adverse event

Datum fӧr senaste ӧversyn 2019 M03 12

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