Diabetologie und Stoffwechsel 2015; 10 - P158
DOI: 10.1055/s-0035-1549664

Indirect comparisons (ICs) of once weekly dulaglutide (DU) plus metformin (MET) versus sulphonylureas (SU) plus MET in patients with type 2 diabetes (T2D) from AWARD-5

J Baeumler 1, E Heitmann 1, C Nicolay 1, H Jung 1
  • 1Lilly Deutschland GmbH, Bad Homburg, Germany

Objective: German “Gemeinsamer Bundesausschuss (G-BA)” determined SU+MET as a comparator for DU+MET. ICs examined the relative efficacy and safety of these regimens in adult patients with T2D.

Methods: Randomised controlled trials (n = 3) were identified by systematic review for ICs with AWARD-5 data; Sitagliptin+MET was the bridging comparator. Eligibility criteria for this second-order IC (Bucher method) included: appropriate comparators; ≥24 weeks' duration; German label doses used; relevant endpoints reported; similar baseline characteristics. DU 1.5 mg was compared with SU at weeks 26/30 (glimepiride), 52 (glipizide) and 104 (glimepiride); all agents+MET.

Results: From ICs of DU vs. SU at 26/30, 52 and 104 weeks, the mean (SE) difference in HbA1c change ranged from -0.54 (0.09)% to -0.67 (0.10)% (p < 0.001 for all). The mean (SE) IC difference in weight change (DU vs. SU) at 26/30, 52 and 104 weeks ranged from -3.17 (0.49)kg to -4.00 (0.50)kg (p < 0.001 for all). The odds ratios for proportion of patients experiencing ≥1 hypoglycaemic event (≤70 mg/dl) with DU vs. SU for the three ICs were 0.58 (p = 0.186), 0.25 (p < 0.001) and 0.16 (p = 0.001) at 26/30, 52 (both total events) and 104 weeks (documented symptomatic events), respectively. The associated absolute risk reductions were 11% (p < 0.001), 22% (p < 0.001) and 11% (p < 0.001) at 26/30, 52 (both total events) and 104 weeks (documented symptomatic events), respectively.

Conclusions: Although these were ICs, they showed that DU 1.5 mg+MET was superior to SU+MET for reducing HbA1c and weight, while decreasing hypoglycaemic risk in patients with T2D, consistent with the expected profile of the GLP-1 class.