Trulicity ® (dulaglutid) injektion

För fullständig produktresumé för Trulicity® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Trulicity® (dulaglutid): Jämförelse med liraglutid (AWARD-6)

Dulaglutid 1,5 mg/vecka var inte sämre än liraglutid 1,8 mg/dag, i kombination med metformin, baserat på förändringen i HbA1c från utgångsvärdet till 26 veckor.

Detailed Information

A phase 3, randomized, 26-week, parallel-arm, open-label, active-comparator, noninferiority study compared once-weekly dulaglutide 1.5 mg with once-daily liraglutide (0.6 mg daily week 1, 1.2 mg daily week 2, and 1.8 mg daily thereafter), both administered SC in patients with T2DM who were unable to achieve optimal glycemic control with metformin (AWARD-6).1

Efficacy Results

Dulaglutide was noninferior to liraglutide based on the change in HbA1c from baseline to 26 weeks. Treatment with both dulaglutide and liraglutide resulted in significant (p<.0001) reductions in HbA1c from baseline, and changes in HbA1c were similar between groups.1

Both treatment groups also experienced reductions from baseline to 26 weeks in 

  • FSG

  • PPG, and

  • BW.1

Safety Results

Dulaglutide and liraglutide had similar safety and tolerability profiles.1

The most frequently reported TEAEs were mainly GI in nature and were not significantly different between treatment groups. The majority of GI AEs were categorized as mild to moderate and transient.1

Gastrointestinal AEs, with nausea being the most common reason, led to discontinuation of study drug in

  • 9 (3%) patients receiving dulaglutide, and

  • 13 (4%) patients receiving liraglutide.1

Total hypoglycemia, defined as plasma glucose ≤3.9 mmol/L (70.2 mg/dL), occurred in

  • 26 (9%) patients receiving dulaglutide, and

  • 17 (6%) patients receiving liraglutide.1

No severe hypoglycemia occurred.1

References

1. Dungan KM, Povedano ST, Forst T, et al. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. Lancet. 2014;384(9951):1349-1357. http://dx.doi.org/10.1016/S0140-6736(14)60976-4

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

PPG = postprandial glucose

SC = subcutaneous

T2DM = type 2 diabetes mellitus

TEAE = treatment-emergent adverse event

Datum fӧr senaste ӧversyn 2018 M11 16


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