Diabetologie und Stoffwechsel 2015; 10 - P246
DOI: 10.1055/s-0035-1549752

Effect of baseline body mass index (BMI; < 30 kg/m2, ≥30-< 35 kg/m2, and ≥35 kg/m2) on glycaemic response and weight change in patients with type 2 diabetes (T2DM) with baseline HbA1c ≥7.5% after treatment with the once-weekly glucagon-like peptide-1 receptor agonist (GLP-1RA), dulaglutide, and active comparators in five clinical studies (AWARD 1 – 5)

M Cummings 1, R Gentilella 2, C Nicolay 3, O Adetunji 4
  • 1Portsmouth NHS Trust, Academic Department of Diabetes and Endocrinology, Portsmouth, United Kingdom
  • 2Eli Lilly Italia, Sesto Fiorentino, Italy
  • 3Lilly Deutschland GmbH, Bad Homburg, Germany
  • 4Eli Lilly & Company, Basingstoke, United Kingdom

Introduction: We investigated the effect of baseline BMI on treatment with dulaglutide and active comparators in patients with T2DM with baseline HbA1c ≥7.5% (AWARD 1 – 5). The National Institute for Health and Care Excellence (NICE) recommends HbA1c ≥7.5% for initiation of GLP-1RA therapy.

Methods: Post-hoc, by-study analyses of change in HbA1c and bodyweight in patients receiving once-weekly dulaglutide 1.5 mg (n = 954) or 0.75 mg (n = 943), exenatide (n = 165), insulin glargine (n = 432), metformin (n = 126) or sitagliptin (n = 224) at 26 weeks.

Results: Across 5 studies, ranges of least squares mean (LSM; standard error [SE]) HbA1c reductions from baseline in patients with BMI < 30 kg/m2, ≥30-< 35 kg/m2 and ≥35 kg/m2, respectively, were: dulaglutide 1.5 mg: 0.89 (0.17)-1.91 (0.12)%; 1.04 (0.16)-1.94 (0.12)%; 1.10 (0.17)-2.12 (0.13)%; dulaglutide 0.75 mg: 0.98 (0.19)-1.83 (0.13)%, 1.03 (0.11)-1.89 (0.12)%, 0.92 (0.16)-1.77 (0.13)%. Reductions in dulaglutide 1.5 mg-treated BMI subgroups were significantly (p < 0.05) greater than in all corresponding exenatide, sitagliptin and glargine-treated subgroups, except ≥35 kg/m2 in AWARD-2. Results were mainly similar for comparisons between dulaglutide 0.75 mg and active comparators. Across all studies, ranges of LSM (SE) bodyweight changes from baseline were: dulaglutide 1.5 mg: 0.12 (0.45) to –2.68 (0.32)kg (< 30 kg/m2), –0.88 (0.44) to –3.13 (0.37)kg (≥30-< 35 kg/m2), –1.38 (0.59) to –3.05 (0.45)kg (≥35 kg/m2); dulaglutide 0.75 mg: 0.87 (0.63) to –2.18 (0.32)kg, 0.29 (0.46) to –2.99 (0.38)kg, 0.25 (0.47) to –2.42 (0.44)kg. Reductions were significantly greater or increases significantly smaller in dulaglutide 1.5 mg-treated BMI subgroups than in two of three sitagliptin-treated subgroups and all corresponding glargine-treated subgroups. Treatment-by-BMI subgroup interaction p-values for change in HbA1c and bodyweight ranged from 0.214 to 0.856.

Conclusions: These data suggest consistent efficacy with both doses of dulaglutide vs. active comparators.