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): Glykemisk kontroll

Farmakokinetiken för Trulicity (dulaglutid) stödjer dosering en gång i veckan hos patienter med typ 2-diabetes mellitus.

Detailed Information

Dulaglutide improves glycemic control by lowering fasting, pre-meal, and postprandial glucose concentrations in patients with type 2 diabetes mellitus.1

Dulaglutide demonstrates gradual absorption and elimination resulting in a relatively flat and stable concentration-time profile over a once-weekly dosing interval at steady state, making it suitable for once-weekly administration.2

A post hoc analysis of the AWARD-3 study was conducted to assess for variability in glycemic control during the week due to peak and trough effects of once-weekly dulaglutide treatment.3 

The AWARD-3 study was selected as it was the only AWARD study where dulaglutide was not used in combination with other antihyperglycemic therapies.3

Eight-point SMBG profiles were collected from patients treated with dulaglutide 1.5 mg and dulaglutide 0.75 mg within 7 days prior to week 26 that included

  • premeal and 2 hours postmeal for morning, midday, and evening

  • bedtime

  • 3 AM, or 

  • 5 hours after bedtime.3

The mean daily SMBG values on days when the plasma dulaglutide concentration was highest and lowest for the week (peak days [day 2/3] and trough days [day 6/7]) were compared.3

The mean daily SMBG concentrations were equivalent for both dulaglutide 1.5 mg and dulaglutide 0.75 mg doses during the peak and trough concentration days (Figure 1).

Figure 1. Mean Daily SMBG Concentrations on Peak and Trough Days for Both Dulaglutide 1.5 mg and Dulaglutide 0.75 mg Doses3

Abbreviation: SMBG= self-monitored blood glucose.

The mean difference in mean daily SMBG concentrations between peak and trough days for dulaglutide 1.5 mg (mean difference -6.55[90 CI, -12.51 to -2.37]) and dulaglutide 0.75 mg (mean difference 0.91[90 CI, -8.65 to 2.31]) were within the 10% clinically acceptable margin of the lower mean peak or trough mean daily SMBG concentrations, allowing them to be considered equivalent.3 

Based on pharmacokinetic-pharmacodynamic modeling, the estimated concentration of dulaglutide remained above the minimum effective concentration of 8.7 ng/mL that was needed to achieve a clinically meaningful HbA1c reduction of 0.4% throughout the week.3

References

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

2. Geiser JS, Heathman MA, Cui X, et al. Clinical pharmacokinetics of dulaglutide in patients with type 2 diabetes: analyses of data from clinical trials. Clin Pharmacokinet. 2016;55(5):625-634. http://rd.springer.com/article/10.1007%2Fs40262-015-0338-3

3. Patel H, Fernández Landó L, Jia N, et al. Steady state blood glucose control for once weekly dulaglutide during peak and trough concentration days. Poster presented at: 77th Annual American Diabetes Association (ADA) Scientific Sessions; June 9-13, 2017; San Diego, CA. https://www.easd.org/virtualmeeting/home.html#!resources/steady-state-blood-glucose-control-for-once-weekly-dulaglutide-during-peak-and-trough-concentration-days-97101472-d0a4-4c05-a53c-817b4d4fc89a

Glossary

AWARD =  Assessment of Weekly AdministRation of LY2189265 in Diabetes 

HbA1c = glycated hemoglobin

PD = pharmacodynamic

PK = pharmacokinetic

SMBG =  self-monitored blood glucose

Datum fӧr senaste ӧversyn 2020 M01 02


Kontakta Medicinsk Information på Lilly

Kontakta oss på telefon

Kontorstid vardagar 9.00-17.00

Eller så kan du

Skriv din fråga till oss